List of Enclosures S. No Content Annexure

LIST OF ENCLOSURES
S. No Content Annexure
1 CFE Copy Enclosure -I
2 CFO Copy Enclosure -II
3 Land Documents Enclosure-III
COPY OF CFE
COPY OF CFO
LAND DOCUMENT
LIST OF ANNEXURES
S. No Content Annexure
1 List of Products Annexure-I
2 Manufaturing Process Description Annexure-II
3 Water Consumption Details Annexure-III
4 Hazardous waste
5 Industrial Process waste
Annexure-IV
6 Sewage sludge
7 Hazardous & Solid waste
8 Stack Emission Details Annexure-V
9 Process Emission Details Annexure-VI
10 List of Raw Materials Annexure- VII
11 List of By - Products Annexure-VIII
12 Waste water Details Annexure-IX

Additional info M/s. Shree Jaya Laboratories Pvt Ltd
Annexure - I
LIST OF PROPOSED PRODUCTS
CAS Therapeutic Quantity

S. No Name of the Product
Number Category In Kg/Month
1 Benzyl Magnesium chloride 6921-34-2 Organic Reagent 10000.00
2 Butyl Magnesium Chloride 693-04-9 Organic Reagent 15000.00
3 Domperidone 57808-66-9 Antiemetic. 5000.00
4 Escitalopram oxalate 219861-08-2 Antidepressant. 3000.00
Esomeprazole Magnesium
5 217087-10-0 Antiulcer Agent 5000.00
trihydrate
6 Ethyl magnesium Chloride 925-90-6 Organic Reagent 15000.00
7 Linezolid 165800-03-3 Antibiotic 2000.00
8 Loperamide hydrochloride 34552-83-5 Ant diarrheal 2000.00
9 Magnesium tert.Butoxide 32149-57-8. Organic Reagent 15000.00
10 Metformin hydrochloride 1115-70-4 Hypoglycemic 50000.00
11 Methyl magnesium chloride 676-58-4 Organic Reagent 20000.00
N,N-Dimethyl propyl
12 - Drug Intermediate 20000.00
magnesium chloride
Proton pump
13 Omeprazole 73590-58-6 20000.00
inhibitor.
Gastric Acid
14 Pantoprazole sodium 138786-67-1 Secretion 15000.00
Inhibitor
100-59-4
Organic
15 Phenyl magnesium chloride 15000.00
Reagents
16 Quetiapine Fumarate 111974-72-2 Antipsychotic, 5000.00
Gastric Acid
17 Rabeprazole Sodium 117976-90-6 Secretion 5000.00
Inhibitor
18 Sodium Methoxide 124-41-4 Antineoplastic 50000.00
19 Sodium tert butoxide 865-48-5 Organic Reagent 20000.00
20 Telmisartan 144701-48-4 Anti hypertensive 3000.00
Total 295000.00
Prepared By Rightsource Industrial Solutions Pvt. Ltd. Page 1

Annexure - II
MANUFACTURING PROCESS
1. BENZYL MAGNESIUM CHLORIDE
Process Description:
Stage-1
Magnesium metal is charged into a clean and dry reactor under nitrogen purging.
Charge DEE & THF and start stirring. Raise the reactor temperature up to required
temperature. Start and continue the addition of benzyl chloride up to completion of the
reaction. Distill off DEE and maintain for few hours and then cool to room temperature.
Check the sample and unload the material into the containers under nitrogen
atmosphere.Check the Product and unload the material into the containers under
Nitrogen atmosphere.
BENZYL MAGNESIUM CHLORIDE
Route of synthesis:
Stage-1:
MgCl
Cl
THF
Mg +
Magnesium Benzyl chloride Benzylmagnesium chloride

24.31 C7H7Cl C7H7ClMg
126.58 150.89
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 2

Flow Chart:
Magnesium
Benzyl chloride Diethyl ether Rec
Stage-1
Diethyl ether THF Rec
Tetrahydrofuran
Material Balance:
Material Balance of Benzyl Magnesium Chloride

Stage-1
Batch Size: 1000.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Benzyl magnesium chloride in 2056.00
Magnesium 160.00
THF Solution
Benzyl chloride 840.00 Diethyl ether Recovery 732.00
Diethyl ether 770.00 Diethyl ether Loss 38.00
Tetrahydrofuran 1100.00 Tetrahydrofuran Loss 44.00
Total 2870.00 Total 2870.00

2. BUTYL MAGNESIUM CHLORIDE
Process Description
Stage-1
Charge THF and start stirring. Raise the reactor temperature up to required
temperature. Start and continue the addition of butyl chloride up to completion of the
reaction. Maintain for few hours and cool to room temperature. Check the Products and
unload the material into the containers under Nitrogen atmosphere.
BUTYL MAGNESIUM CHLORIDE
Route of Synthesis
Stage-1
Nitrogen Mg CH3
Mg + Cl CH3 Cl
THF
Butyl Magnesium Chloride
Magnesium Butyl chloride
C4H9MgCl
24.31 C4H9Cl
92.57 116.87

Flow Chart
Magnesium Metal
Butyl Chloride Stage-1 THF Rec
THF
Material Balance:
Material Balance of Butyl Magnesium Chloride

Stage-1
Batch Size: 1000.0 Kgs
in Kg in Kg
Butyl Magnesium Chloride in 1768.00
Magnesium Metal 210.00
THF Solution
Butyl Chloride 790.00 THF Loss 40.00
THF 805.00
Total 1808.00 Total 1808.00

3. DOMPERIDONE
Stage-1
N-carbethoxy-4-piperidone is reacted with Hydrogen and Ammonia in the presence of

Raney nickel as catalyst and Methanol as solvent media to give stage-1 as product.
Stage-2
Stage-1 reacts with 2, 5-Dichloro nitrobenzene & Sodium Carbonate in presence of

Methanol as a solvent media to give Stage-2 as product.
Stage-3
Stage-2 reacts with Hydrogen in presence of Raney Nickel as catalyst and Toluene
as solvent media to give Stage-3 as product.
Stage-4
Stage-3 reacts with Urea in the presence of Sodium Hydroxide as a solvent media to
give Stage-4 as product.
Stage-5
Stage-4 undergoes hydrolysis with Sodium Hydroxide to give Stage-5 as product.
Stage-6
Stage-5 reacts with 1-(3-chloropropyl)-1, 3-dihydro-2H-benzimedazole-2-one and

Sodium Carbonate in the presence of Methyl Isobutyl Ketone as solvent media to give
Domperidone as product.

DOMPERIDONE
Route of synthesis:
Stage-1
O NH2
Raney Nickel +
+ H2 + NH3 H 2O
N N
O O CH3 O O CH3
Ammonia 4-Amino-piperidine-1- 18.00

N-Carbethoxy-4-piperidone Hydrogen
carboxylic acid ethyl ester
C8H13NO3 2.00 17.03
C8H16N2O2
171.19
172.22
Stage-2
Cl
NH2
HN
NO2
Cl NO2
1
Methanol
+ + /2 Na2CO3
N
Cl N
O O CH3
O O CH3
4-Amino-piperidine-1- 2,5-Dichloro Sodium 4-(4-Chloro-2-nitro-phenylamino)

carboxylic acid ethyl ester Nitrobenzene carbonate -piperidine-1-carboxylic acid ethyl ester
1
C8H16N2O2 C6H3Cl2NO2 /2X105.98=52.99 C14H18ClN3O4
172.22 192.00 327.76
NaCl + 1/2 CO2 1

+ + /2 H2O
Sodium chloride Carbon dioxide 1

/2X18=9.00
1
58.44 /2X44=22.00

Stage-3
Cl
Cl
HN
HN
NH2
NO2
Raney Nickel
+ 3 H2
Toluene N
N
O O CH3
O O CH3
4-(4-Chloro-2-nitro-phenylamino) Hydrogen 4-(2-Amino-4-chloro-phenylamino)

-piperidine-1-carboxylic acid ethyl ester -piperidine-1-carboxylic acid ethyl ester
3X2=6.00
C14H18ClN3O4 C14H20ClN3O2
327.76 297.78
+ 2H2O
2X18=36.00
Stage-4
H
Cl Cl N
O
HN N
NH2 O
NaOH
+ N
N H2N NH2
O O CH3
O O CH3
4-(2-Amino-4-chloro-phenylamino) 4-(5-Chloro-2-oxo-2,3-dihydro-
Urea
-piperidine-1-carboxylic acid ethyl ester enzoimidazol-1-yl)-piperidine-1-
CH4N2O carboxylic acid ethyl ester
C14H20ClN3O2
60.05 C15H18ClN3O3
297.78
323.77
+ 2NH3
Ammonia
2X17.03=34.06

Stage-5
Cl H
N
Cl H
O N
N O
N
+ NaOH
N
N
O O CH3 H
4-(5-Chloro-2-oxo-2,3-dihydro-benzoimidazol Sodium hydroxide 5-Chloro-1-piperidin-4-yl-1,3

-1-yl)-piperidine-1-carboxylic acid ethyl ester -dihydro-benzoimidazol-2-one
40.00
C15H18ClN3O3 C12H14ClN3O
323.77 251.71
+ C2H5ONa + CO2
Sodium ethoxide Carbon dioxide

68.05 44.00

Stage-6
Cl H
N
O H
N N MIBK
1
O + /2Na2CO3
+
N
Cl
N
H
5-Chloro-1-piperidin-4-yl-1,3 1-(3-chloropropyl)-1,3-dihydro Sodium carbonate
-dihydro-benzoimidazol-2-one -2H-(Benzimidazole-2-one) 1
/2X105.98=52.99
C12H14ClN3O C10H11ClN2O
251.71 210.66
N
N
O 1/ CO
+ 1
N + NaCl /2 H2O + 2 2
N
H O Cl
N
H
Sodium chloride Water Carbon dioxide

Domperidone
1 1/
C22H24ClN5O2 58.44 /2X18=9.00 2X44=22.00
425.91

DOMPERIDONE
Flow Chart:
N-Carbethoxy-4-piperidone Product
Ammonia gas Methanol Rec
Methanol Stage-1
Raney Nickel 70.0 Kg
Hydrogen Effluent water
Stage-1 Product
2,5-Dichloro Nitrobenzene Methanol Rec
Stage-2
Sodium Carbonate
95.0 Kg
Methanol
Effluent water
Stage-2 Product
Hydrogen Toluene Rec
Raney Nickel Stage-3
Toluene 75.0 Kg
Effluent water
Stage-3 Product
Urea Ammonia
Stage-4
Sodium Hydroxide (48%) 67.0 Kg
Effluent water
Stage-4 Product
Sodium Hydroxide Carbon Dioxide
Stage-5
45.0 Kg
Effluent water
Stage-5
1-(3-Chloropropyl)-1,3-dihydro Product
2H-benzimedazole-2-one Sodium chloride
Sodium Carbonate Stage-6
50.0 Kg CO2
Methyl Isobutyl Ketone
Effluent water
DOMPERIDONE

DOMPERIDONE
Material Balance:
Material Balance of Domperidone

Stage-1
Batch Size:50Kg
in Kg in Kg
N-Carbethoxy-4-piperidone 80.00 Stage-1 70.00
Ammonia gas 28.00 Methanol Recovery 283.00
Methanol 300.00 Methanol Loss 15.00
Raney Nickel 20.00 Spent Raney Nickel 20.00
Hydrogen 5.00 Generated water 8.40
Process Emission 24.00
(Ammonia-20,Hydrogen-4)
Organic Residue 12.60
(Organic Impurities-10.6,Methanol-
2)
Total 433.00 Total 433.00

Stage-2
Batch Size:50Kg
in Kg in Kg
Stage-1 70.00 Stage-2 95.00
2,5-Dichloro Nitrobenzene 78.00 Methanol Recovery 470.00
Sodium Carbonate 30.00 Methanol Loss 25.00
Methanol 500.00 Effluent Water 538.85
Water 500.00 (Water-500,generated water-
3.65,Sodium chloride-23.7,Sodium
carbonate-8.5,Methanol-3)
(Carbon dioxide)
(Organic Impurities-38.22,
Methanol-2)
Total 1178.00 Total 1178.00


Stage-3
Batch Size:50Kg
in Kg in Kg
Stage-2 95.00 Stage-3 75.00
Hydrogen 5.00 Toluene Recovery 330.00
Raney Nickel 10.00 Toluene Loss 17.00
Toluene 350.00 Raney Nickel Reuse 10.00
Water 400.00 Effluent Water 411.43
(Water-400,generated water-10.43,
Toluene-1)
(Hydrogen)
(Organic Impurities-11.3,Toluene-2)

Stage-4
Batch Size:50Kg
in Kg in Kg
Stage-3 75.00 Stage-4 67.00
Urea 20.00 Effluent Water 664.90
Sodium Hydroxide (48%) 60.00 (Water-600,Urea-4.9,Sodium
hydroxide-28.8,water from sodium
hydroxide-31.2)
Water 600.00 Process Emission 8.57
(Ammonia)


Stage-5
Batch Size:50Kg
in Kg in Kg
Stage-4 67.00 Stage-5 45.00
Sodium Hydroxide 15.00 Effluent Water 420.70
Water 400.00 (Water-400,Sodium hydroxide-6.7,
Sodium ethoxide-14)
(Carbon dioxide)

Stage-6
Batch Size:50Kg
in Kg in Kg
Stage-5 45.00 Domperidone 50.00
1-(3-Chloropropyl)-1,3-dihydro- 40.00 Methyl Isobutyl Ketone Recovery 1135.00
2H-benzimedazole-2-one
Sodium Carbonate 20.00 Methyl Isobutyl Ketone Loss 60.00
Methyl Isobutyl Ketone 1200.00 Effluent Water 424.50
Water 400.00 (Water-400,generated water-
1.6,Sodium chloride-10.4,Sodium
carbonate-10.5,MIBK-2)
(Carbon Dioxide)
(Organic Impurities-28.57,MIBK-3)
Total 1705.00 Total 1705.00

4. ESCITALOPRAM OXALATE
Stage-1
5-Bromo phthalide reacts with P-Fluoro Magnesium chloride in the presence of

Toluene as a solvent media to give stage-1 as product.
Stage-2
Stage-1 reacts with HBr in the presence of Toluene as a solvent media to give stage-2
as product.
Stage-3
Stage-2 reacts with MPR as a resoluting agent in the presence of Toluene as a solvent
media to give stage-3 as product.
Stage-4
Stage-3 undergoes resolution in the presence of Toluene as a solvent media to give

stage-4 as product.
Stage-5
Stage-4 undergoes cyclisation in the presence of Toluene as a solvent media to give

stage-5 as product.
Stage-6
Stage-5 reacts with Oxalic acid in the presence of Toluene as a solvent media to give
stage-6 as product.
Stage-7
Stage-6 reacts with cuprous cyanide in the presence of Toluene as a solvent media to
give stage-7 as product.
Stage-8
Stage-7 reacts with Oxalic acid in the presence of Toluene as a solvent media to give
Escitalopram Oxalate as product.

ESCITALOPRAM OXALATE
Route of synthesis:
Stage-1:
Br MgBr H3C
N MgCl Toluene
O + + + 3H2O
H3 C
F
O
5-Bromo pthalide P-Fluoromagnesium Dimethyl amino 3X18=54.00

C8H5BrO2 bromide magnesium chloride
C6H4BrFMg C5H12ClMgN
213.02
199.30 145.91
Br
OH
CH3
OH
N
CH3
+ Mg(Br)OH + Mg(Cl)OH
F
4-Dimethylamino-1-(4-fluoro- Magnesium Magnesium
phenyl)-1-(2-hydroxymethyl- hydroxy bromide hydroxy chloride
phenyl)-butan-1-ol 121.21 76.76
C19H23BrFNO2
396.29

Stage-2:
Br
Br OH
OH CH3
CH3 OH
OH N
N CH3
CH3
Toluene HBr
+ HBr
F
F
4-Dimethylamino-1-(4-fluoro- Hydrobromic acid 4-Dimethylamino-1-(4-fluoro-

phenyl)-1-(2-hydroxymethyl- phenyl)-1-(2-hydroxymethyl-
80.91
phenyl)-butan-1-ol phenyl)-butan-1-ol
C19H23BrFNO2 C19H23BrFNO2.HBr
396.29 477.20
Stage-3:
Br
OH H3 C O OH
CH3 O
OH
N O Toluene
CH3 O
+
HBr O
O OH CH3
4-Dimethylamino-1-(4-fluoro- MPR
phenyl)-1-(2-hydroxymethyl- C20H18O8
phenyl)-butan-1-ol Hydrobromide
386.35
C19H23BrFNO2.HBr
477.20
Br
OH
CH3 H3C O OH
OH O
N
CH3 O + HBr
O
O
O OH CH3
F
Hydrobromic acid
1-(4-Bromo-2-hydroxymethyl-phenyl)-4-dimethylamino
-1-(4-fluoro-phenyl)-butan-1-ol with (+)/(-) MPR Salt 80.91
C19H23BrFNO2.C20H18O8
782.64

Stage-4:
Br
OH H3C O OH
CH3 O
OH
N Toluene
CH3 O
O
O
O OH CH3
F
1-(4-Bromo-2-hydroxymethyl-phenyl)-4-dimethylamino
-1-(4-fluoro-phenyl)-butan-1-ol with (+)/(-) MPR Salt
C19H23BrFNO2.C20H18O8
782.64
Br
OH
CH3
OH H3C O OH
N O
CH3
O
+ O
O
O OH CH3
F
1-(4-Bromo-2-hydroxymethyl-phenyl)- MPR
4-dimethylamino-1-(4-fluoro-phenyl)-butan-1-ol
C20H18O8
C19H23BrFNO2 386.35
396.29

Stage-5:
Br Br
OH O CH3
CH3
OH N
N CH3
CH3 Toluene
F
F
1-(4-Bromo-2-hydroxymethyl-phenyl)- {3-[5-Bromo-1-(4-fluoro-phenyl)-1,3-dihydro-
4-dimethylamino-1-(4-fluoro-phenyl)-butan-1-ol isobenzofuran-1-yl]-propyl}-dimethyl-amine
C19H21BrFNO
C19H23BrFNO2
378.27
396.29
+ H2 O
18.00
Stage-6:
Br
O CH3
N O OH
CH3
Toluene
+
HO O
F
{3-[5-Bromo-1-(4-fluoro-phenyl)-1,3-dihydro-isobenzofuran- Oxalic acid

1-yl]-propyl}-dimethyl-amine C2H2O4
C19H21BrFNO 90.03
378.27
Br
O CH3
N
CH3 O OH
HO O
F
{3-[5-Bromo-1-(4-fluoro-phenyl)-1,3-dihydro-isobenzofuran-
1-yl]-propyl}-dimethyl-amine salt of Oxalic acid
C19H21BrFNO.C2H2O4
474.36

Stage-7:
Br
O CH3
N
CH3 O OH Toluene
CuCN
+
HO O
F
{3-[5-Bromo-1-(4-fluoro-phenyl)-1,3-dihydro-isobenzofuran- Cuprous cyanide

1-yl]-propyl}-dimethyl-amine salt of Oxalic acid 89.56
C19H21BrFNO.C2H2O4
468.31
NC
O CH3
N O OH
CH3
+ CuBr +
HO O
F
{3-[5-Cyano-1-(4-fluoro-phenyl)-1,3-dihydro- Cuprous bromide Oxalic acid
isobenzofuran-1-yl]-propyl}-dimethyl-amine 90.03
143.45
C20H21FN2O
324.39

Stage-8:
NC
O CH3
N O OH
CH3
Toluene
+
HO O
{3-[5-Cyano-1-(4-fluoro-phenyl)-1,3-dihydro- Oxalic acid

isobenzofuran-1-yl]-propyl}-dimethyl-amine C 2 H2 O 4
C20H21FN2O 90.03
324.39
NC
O CH3
N
CH3 O OH
HO O
F
{3-[5-Cyano-1-(4-fluoro-phenyl)-1,3-dihydro-
isobenzofuran-1-yl]-propyl}-dimethyl-amine salt of Oxalic acid
C20H21FN2O.C2H2O4
414.42

Stage-9
NC
NC
O CH3
O CH3
N
N CH3 O OH
CH3 O OH
IPA
HO O
HO O
F
F
Esitolopram oxalate
Esitolopram oxalate
C20H21FN2O.C2H2O4
C20H21FN2O.C2H2O4
414.42
414.42

Flow Chart:
Bromophthalide
Fluorobromobenzene
Dimethyl amino propyl Stage-1 Effluent water
magnesium chloride
Magnesium turnings
Stage-1
Hydrobromic acid Toluene Rec
Stage-2 Effluent water
Activated carbon
Toluene
Stage-2
MPR IPA Rec
Activated carbon Stage-3 Toluene Rec
IPA Effluent water
Toluene
Stage-3
Toluene Rec
Sodium hydroxide
Stage-4 Effluent water
Sodium sulfate
Toluene
Stage-4
Methane sulfonyl chloride Acetone Rec
Triethylamine Stage-5 Effluent water
Sodium sulfate
Toluene

Stage-5
Oxalic acid Stage-6 Acetone Rec
Acetone
Stage-6
Sodium hydroxide DMF Rec
Copper cyanide Stage-7 Toluene Rec
Ethylene di amine
DMF
Toluene
IPA Rec
Stage-7 Toluene Rec
Oxalic acid Stage-8
Effluent water
Toluene
IPA
Stage-8
IPA Stage-9 IPA Rec
Activated carbon

Material Balance:
Material Balance of Escitalopram oxalate

Stage-1
Batch Size: 100 Kgs
in Kg in Kg
Bromo phthalide 110.00 Stage-1 200.00
Fluoro bromo benzene 103.00 Toluene Recovery 474.00
Dimethyl amino propyl magnesium 76.00 Toluene Loss 25.00
chloride
Magnesium turnings 28.00 THF Recovery 949.00
Acetic acid 87.00 THF Loss 50.00
Iodine 3.00 Effluent water 883.80
Ammonia Liq 90.00 (Water-572.2, Magnesium hydroxyl
bromide-62.6,Magnesium hydroxyl
chloride-40,Magnesium turnings-
28,Acetic acid-87, Ammonia-
9,Water from ammonia-81,Iodine-
3, THF-1)
Activated carbon 4.00 Spent carbon 4.00
Toluene 500.00 Organic Residue 15.20
Tetrahydrofuran 1000.00 (Organic Impurites-14.2,Toluene-
1)
Water 600.00
Total 2601.00 Total 2601.00


Stage-2
Batch Size: 100 Kgs
in Kg in Kg
Stage-1 200.00 Stage-2 225.00
Hydro bromic acid 41.00 Toluene Recovery 333.00
Activated carbon 5.00 Toluene Loss 17.00
Toluene 350.00 Effluent water 601.00
Water 600.00 (Water-600,Toluene-1) 0
Spent carbon 5.00
Total 1196.00 Total 1196.00

Stage-3
Batch Size: 100 Kgs
in Kg in Kg
Stage-2 225.00 Stage-3 350.00
MPR 173.00 Toluene Recovery 1424.00
Caustic flakes 38.30 Toluene Loss 75.00
Sodium sulfate 62.00 IPA Recovery 949.00
Activated carbon 7.30 IPA Loss 50.00
IPA 1000.00 Effluent water 677.34
Toluene 1500.00 (Water-600,Generated water-
8.47,Sodium bromide-48.4,Sodium
hydroxide-19.47,Toluene-1)
Water 600.00 Inorganic sold waste 62.00
(Sodium sulfate)
Organic solid waste 10.96
(Organic Impurities-9.96,IPA-1)
Spent carbon 7.30
Total 3605.60 Total 3605.60


Stage-4
Batch Size: 100 Kgs
in Kg in Kg
Stage-3 350.00 Stage-4 165.00
Sodium hydroxide 10.00 Toluene Recovery 6173.00
Sodium sulfate 100.00 Toluene Loss 325.00
Water 400.00 (Water-400,Sodium hydroxide-
10,Toluene-1)
Inorganic solid waste 100.00
(Sodium sulfate)
MPR Reagent Reuse 173.00
Organic Solid waste 13.00
(Organic Impurities-12,Toluene-1)
Total 7360.00 Total 7360.00

Stage-5
Batch Size: 100 Kgs
in Kg in Kg
Stage-4 165.00 Stage-5 150.00
Methane sulfonyl chloride 50.00 Toluene Recovery 6173.00
Triethylamine 15.00 Toluene Loss 325.00
Sodium chloride 20.00 Effluent water 493.50
Sodium sulfate 100.00 (Water-400,Generated water-7.5,
Methane sulfonyl chloride-50,
Sodium chloride-20,Triethyl
amine-15,Toluene-1)
Toluene 6500.00 Inorganic solid waste 100.00
Water 400.00 (Sodium sulfate)
(Organic Impurities-7.5,Toluene-1)
Total 7250.00 Total 7250.00


Stage-6
Batch Size: 100 Kgs
in Kg in Kg
Stage-5 150.00 Stage-6 180.00
Oxalic acid 40.00 Acetone Recovery 1095.00
Acetone 1152.00 Acetone Loss 56.00
(Organic Impurities-10,Acetone-1)
Total 1342.00 Total 1342.00

Stage-7
Batch Size: 100 Kgs
in Kg in Kg
Stage-6 180.00 Stage-7 120.00
Copper cyanide 45.00 Toluene Recovery 2660.00
Copper iodide 57.00 Toluene Loss 139.00
Ethylene di amine 267.00 DMF Recovery 2173.00
DMF 2288.00 DMF Loss 114.00
Toluene 2800.00 Ethylene di amine Recovery 254.00
Water 300.00 Ethylene di amine Loss 13.00
Effluent water 458.00
(Water-300,Cuprous bromide-
56,Oxalic acid-44,Copper iodide-
57,DMF-1)
(Organic Impurities-5,Toluene-1)
Total 5937.00 Total 5937.00


Stage-8
Batch Size: 100 Kgs
in Kg in Kg
Stage-7 120.00 Stage-8 129.00
Oxalic acid 34.00 Toluene Recovery 2659.00
Ammonia Liquid 114.00 Toluene Loss 140.00
Acetic acid 34.00 Isopropyl ether Recovery 228.00
Activated carbon 50.00 Isopropyl ether Loss 12.00
Hyflow 10.00 Acetone Recovery 542.00
Toluene 2800.00 Acetone Loss 28.00
Isopropyl ether 240.00 Effluent water 550.00
Acetone 572.00 (Water-400,Acetic acid-34,
Ammonia-11.4,Water from
ammonia-102.6, Toluene-1,
Acetone-1)
Water 400.00 Spent carbon &Hyflow 60.00
(Organic Impurities-25,Acetone-1)
Total 4374.00 Total 4374.00

Stage-9
Batch Size: 100 Kgs
in Kg in Kg
Stage-8 129.00 Escitalopram oxalate 100.00
IPA 3200.00 IPA Recovery 3039.00
Activated carbon 14.00 IPA Loss 160.00
Spent carbon 14.00
(Organic Impurities-29,IPA-1)
Total 3343.00 Total 3343.00

5. ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Process
Description:
Stage-1
5-Methoxy-2-[(4-Methoxy-3,5-Dimethyl-2-pyridinyl) Methyl Thio]-1H-

Benzimidazole reacts with Cumin hydroperoxide and Potassium hydroxide in the
presence of Toluene as a solvent media to give stage-1 as product.
Stag
e-2
Stage-1 undergoes hydrolysis with Magnesium sulfate in the presence of Toluene

as a solvent media to give Esomepraszole Magnesium Trihydrate as product.

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Route of synthesis:
Stage-1:
OCH3 CH3
OH
H3C CH3 H3C O
N OCH3
Toluene
N C S + KOH
+
H2
N
H
5-Methoxy-2-[(4-methoxy-3, 5-dimethyl-pyridin Cumin hydroperoxide Potassium hydroxide

-2-ylmethyl Thio]-1H -Benzoimidazole C9H12 O2 56.10
C17H19N3O2S 152.19
329.41
OCH3
CH3
H3C CH3 H3C OH
O N OCH3
N C S H2O +
H2
N
K+
Esomeprazole potassium salt.Monohydrate Cumin hydroxide

C9H12 O
C17H20KN3O4S
136.19
401.52

Stage-2:
OCH3
H3C CH3
O N OCH3
2 N C S H2O + MgSO4 + H2O
H2
N
K+
Esomeprazole potassium salt.Monohydrate Magnesium sulfate 18.00
C17H20KN3O4S 120.36
2X401.52=803.04
OCH3
H3C CH3
O N OCH3 K2SO4
Mg 3H2O +
N C S
H2
N 2
Esomeprazole Magnesium Tri Hydrate Potassium sulfate

C17H18N3O3S.Mg3H2O 174.25
767.15

Flow Chart:
Omeprazole sulfide
Cumin hydroperoxide Stage-1 Methanol Rec
Potassium hydroxide
Methanol
Stage-1
Magnesium sulfate Stage-2 Effluent Water
Water
ESOMEPRAZOLE MAGNESIUM


Material Balance:
Material Balance of Esomeprazole Magnesium trihydrate

Stage-1
Batch Size: 100 Kgs
Name of the input Quantity in Name of the out put Quantity in
Kg Kg
in Kg In Kg
Omeprazole sulfide 88.00 Stage-1 107.00
Cumin hydro peroxide 41.00 Toluene Recovery 305.00
Potassium hydroxide 15.20 Toluene loss 15.00
DET 11.30 Methanol Recovery 95.00
Titanium isopropoxide 2.50 Methanol Loss 5.00
NEDIPA 4.50 NEDIPA Loss 4.50
Methanol 100.00 (DET-11.3,Titanium
isopropoxide-2.5,Cumin
hydroxide-37.2,)
Material Balance of Esomeprazole Magnesium trihydrate

Stage-2
Batch Size: 100 Kgs
Name of the input Quantity in Name of the out put Quantity in
Kg Kg
Name of the input Quantity in Name of the out put Quantity
Kg In Kg
Stage-1 107.00 Esomeprazole Magnesium 100.00
trihydrate
Magnesium sulfate 16.00 Effluent water 980.80
Water 960.00 (Water-957.6,Potassium
sulfate-23.2)
Total 1083.00 Total 1083.00

6. ETHYL MAGNESIUM CHLORIDE
Stage-1
Magnesium metal is charged into a clean and dry reactor under Nitrogen purging,
temperature. Start and continue the addition of ethyl chloride up to completion of
the reaction. Maintain few hours and cool to room temperature. Check sample and
unload the material into containers under Nitrogen atmosphere.
ETHYL MAGNESIUM CHLORIDE
Route of Synthesis:
Stage-1:
THF
Mg H3C Cl H3C MgCl
+
Magnesium Ethyl Chloride Ethyl Magnesium Chloride

24.31 64.51 C2H5MgCl
88.82

Flowchart:
Ethyl Chloride
Mg turnings Stage-1 THF Recovery
THF
Material Balance:
Material Balance of Ethyl Magnesium Chloride

Stage-1
in Kg in Kg
Ethyl Magnesium Chloride in 2425.00
Ethyl Chloride 724.00
THF Solution
Mg turnings 276.00 THF Loss 75.00
THF 1500.00
Total 2500.00 Total 2500.00

7. LINEZOLID
Stage-1:
N-[3-pthalimido-2R-Hydroxy propyl]-3-(fluoro-4-morpholinyl) aniline is treated with

carbonyl diimidazole, Hydrazine hydrate and acetic anhydride in the presence of
MDC and Methanol to give Linezolid as product.

LINEZOLID
Route of Synthesis:
Stage-1
O
O N NH O
OH
N N N
F
O + NH HN
2-[3-(3-Fluoro-4-morpholin-4-yl-phenylamino) +
-2-hydroxy-propyl]-isoindole-1,3-dione Carbonyl diimidazole
C 7 H 6 N4 O
C21H22 FN3O4
162.15
399.42
O O
O H2 N
H H NH2 MDC
+ O
Hydrazine hydrate Acetic anhydride
H6N2O C4H6O3
50.06
102.09
O
O
O N N H
N CH3 HN
F N
O + 2 + CH3COOH
Linezolid
Imidazole 60.0
C16 H20FN3O4 C 3 H 4 N2
337.35
2X68.08=136.16
OH
N
N
+
+ H2 O
OH
Phthalazine -1,4-diol
18.0
C8H6N2O2
162.15
LINEZOLID

Flow Chart:
N-[3-Phthalimido-2R-hydroxy
propyl-3-fluoro-4-
morpholinyl aniline Stage-1 Methanol Rec
Carbonyl diimidazole
Hydrazine Hydrate
Methanol
LINEZOLID
LINEZOLID
Material Balance:
Material balance of Linezolid

Stage-1
Batch Size:90.0 Kg
in Kg In Kg
N-[3-Phthalimido-2R- 110.00 Linezolid 90.00
hydroxypropyl-3-fluoro-4-
morpholinyl aniline
Carbonyl di imidazole 43.25 Methanol Recovery 710.00
Hydrazine Hydrate 13.35 Methanol Loss 37.00
Acetic anhydride 27.23 MDC Recovery 2548.00
Methanol 753.00 MDC Loss 134.00
MDC 2682.00 Ethyl acetate Recovery 765.00
Activated carbon 10.80 Ethyl acetate Loss 40.00
Ethyl acetate 805.00 Acetone Recovery 1471.00
Water 1422.00 Effluent water 1523.38
(Water-1422,Generated water-
4.8,Acetic acid-16,Phthalazine-
1,4-diol-43.25,Methanol-
1,Imidazole-36.33)
Spent carbon 10.80
(Organic Impurities-
3.45,Methanol-5)
Total 7414.63 Total 7414.63

8. LOPERAMIDE HYDROCHLORIDE
Stage-1:
N-(3,3-diphenyldihydrofuran-2(3H)-ylidene)-N-methylmethanaminium bromide is
reacted with 4-(Chloro phenyl) - Piperidine –4-ol in presence of Potassium
carbonate(K2CO3), Potassium iodide(KI), Potassium hydroxide (KOH) acetone,
Toluene ,HCl & Water to get Stage-1 compound.
Stage-2
Stage I is reacted with Methanolic HCl and then it is purified in presence of Acetone,
Methanol & Activated carbon to get Loperamide HCl (Pharama)

LOPERAMIDE HYDROCHLORIDE
Route of Synthesis
Stage-1:
O
N+ Br- OH Cl
HN 1/2 K2 CO3
+
+
Potassium
N-(3,3-diphenyldihydrofuran- 4-(Chloro phenyl) -
Carboante
2(3H)-ylidene)-N-methylm Piperidine -4-ol
C11H14ClNO 1/2X138.21=69.1
ethanaminium bromide
C18H20BrNO 211.69
346.26
Acetone / KI
OH
N
O Cl
N
+ KBr + 1/2 CO2 + 1/2H2O
4-[4-(4-chlorophenyl)-4-hydroxy 119.0 1/2X44=22.0 1/2X18=9.0

piperidin-1-yl]-N,N-dimethyl-2,2-
diphenylbutanamide
C29H33ClN2O2
477.04

Stage-2:
OH
Cl
N
N
O
Methanol
+ HCl
Carbon
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]- Hydrochloric Acid

N,N-dimethyl-2,2-diphenylbutanamide 36.46
C29H33ClN2O2
477.04
OH
Cl
N
N
O Cl
H
4-[4-(4-chlorophenyl)-4-hydroxy
piperidin-1-yl]-N,N-dimethyl-2,2-
diphenylbutanamide Hydrochloride
C29H34Cl2N2O2
513.50

Flow Chart
N-[(2Z)-3-(diphenylmethyl)dihydra
furan-2(3H)-ylidene]methanamine Acetone Rec
4-(Chloro phenyl)-Piperidine-4-ol Stage-1 Effluent water
Potassium carbonate
Acetone
Stage-1 Methanol Rec

Stage-2 Acetone Rec
Methanol
Acetone Spent carbon
Methanolic HCl
Activated Carbon LOPERAMIDE HYDROCHLORIDE

Material Balance
Material Balance of Loperamide Hydrochloride

Stage-1
BatchSize:180 Kg
in Kg in Kg
N-[(2Z)-3- 122.00 Stage-1 168.00
(diphenylmethyl)dihydrafuran-
2(3H)-ylidene]methanamine
4-(Chloro phenyl)-Piperidine-4-ol 75.00 Acetone Recovery 563.00
Potassium carbonate 25.00 Acetone Loss 30.00
Potassium Iodide 1.00 Effluent Water 3051.11
Acetone 600.00 (Water-3000,generated water-
3.19,Potassium bromide-41.92,
Acetone-5 , Potassium Iodide-1
Water 3000.00 Process Emission 7.96
(Carbon dioxide)
Acetone-2)
Total 3823.00 Total 3823.00

Material Balance of Loperamide Hydrochloride

Stage-2
BatchSize:180Kg
in Kg in Kg
Stage-1 168.00 Loperamide Hydrochloride 180.00
Methanol 600.00 Methanol Recovery 677.50
Acetone 300.00 Methanol Loss 30.00
Methanolic HCl (10%) 125.00 Acetone Recovery 280.00
Activated Carbon 20.00 Acetone Loss 20.00
Spent Carbon 20.00
Methanol-5)
Total 1213.00 Total 1213.00

9. MAGNESIUM TERTIARY BUTOXIDE
Process Description
Stage-1
2 moles of Methyl Magnesium Chloride in THF are reacted under certain conditions
to form Di methyl Magnesium and Magnesium Chloride.
Stage-2
Di methyl Magnesium in THF is reacted with Tertiary Butanol to get Magnesium

Tertiary Butoxide. The Magnesium Tertiary Butoxide solution in THF is taken into a
dryer and THF is recovered and used in next batches. The dried product is packed in
polythene bags and kept in MS drums.

MAGNESIUM TERTIARY BUTOXIDE
Route of Synthesis
Stage-1
THF
2 CH3MgCl (CH3)2Mg + MgCl2
Di MethylMagnesium Magnesium Chloride

Methl magnesium chloride
95.21
2X74.79=149.58 54.37
Stage-2
CH3
2 H3C OH THF
(CH3)2Mg (C4H9O)2Mg + 2 CH4
+ CH3
Tert Butanol Magnesium Tertiary Methane gas

Dimethyl Magnesium
C4H9OH Butoxide 2X16.04=32.08
54.37 C8H18MgO2
2X74.12=148.24
170.53

Flow Chart
Methyl magnesium Chloride THF Rec

THF Stage-1
MgCl2(Byproduct)
Stage-1 Methane gas

Stage-2
Tert-Butanol Tert-Butanol Rec
Material Balance:
Material Balance of Magnesium Tertiary Butoxide

Stage-1
Batch Size:200.0Kgs
in Kg in Kg
Methyl Magnsium Chloride 214.00 Stage-1+ THF 1400.00
THF 1400.00 THF Loss 70.00
By-product 144.00
(Magnesium chloride-144)
Total 1614.00 Total 1614.00

Material Balance of Magnesium Tertiary Butoxide

Stage-2
in Kg in Kg
Magnesium Tertiary Butoxide in 1528.00
Stage-1 + THF 1369.30
THF Solution
Tert-Butanol 200.00 Process Emission 41.30
(Methane gas-41.30)
Total 1569.30 Total 1569.30

10. METFORMIN HYDROCHLORIDE
Process Description
Dimethylamine hydrochloride reacts with Dicyanodiamide in the presence of Xylene

and Water Solvent media to produce aqueous layer containing Metformin
Hydrochloride which is purified with Activated carbon in the presence of Methanol
Solvent media to produce Metformin Hydrochloride.
METFORMIN HYDROCHLORIDE
Route of Synthesis:
Stage-1:
CH3
NH
H H
N N N NH2
H CN H3C
H3C CH3 Xylene H
Cl + H2N N
H Cl
NH NH
Dimethyl amine Hydrochloride N-Cyanoguanidine
Metformin Hydrochloride
C2H8NCl C2H4N4 C4H12N5Cl
81.58 84.08 165.66

Flow Chart:
Dimethylamine Hcl
N-Cyano guanidine Xylene Recovery
Stage - 1
Xylene Methanol Recovery
Methanol
Metformin
Hydrochloride
Material Balance:
Material Balance of Metformin Hydrochloride

Stage-1
Batch Size: 250Kg
in Kg in Kg
Dimethyl amine Hcl 126.00 Metformin Hydrochloride 250.00
N-Cyano guanidine 130.00 Xylene Recovery 285.00
Xylene 300.00 Xylene Loss 15.00
Activated carbon 2.00 Methanol Recovery 90.00
Hyflo 1.00 Methanol Loss 5.00
Methanol 100.00 Effluent water 324.00
Water 320.00 (Water-320,Methanol-1,Dimethyl
Amine Hydrochloride-3)
Spent carbon + Hyflo 2.00
(Organic Impurities-4,Methanol-4)

11. METHYL MAGNESIUM CHLORIDE
Process Description
Stage-1
temperature. Start and continue the addition of methyl chloride up to completion of
the reaction. Maintain for few hours and cool to room temperature. Check Product
and unload the material into the containers under nitrogen atmosphere.
METHYL MAGNESIUM CHLORIDE
Route of Synthesis
Stage-1
Mg + CH3Cl Nitrogen CH3MgCl

THF
Methyl Magnesium Chloride
Magnesium Methyl chloride
50.49 74.79
24.31

Flow Chart
Magnesium Metal
Methyl Chloride Stage-1 THF Rec
THF
Material Balance:
Material Balance of Methyl Magnesium Chloride

Stage-1
in Kg in Kg
Methyl Magnesium Chloride in 4156.50
Magnesium Metal 974.00
THF Solution
Methyl Chloride 2026.00 THF Loss 113.50
THF 1270.00
Total 4270.00 Total 4270.00

12. N, N-DIMETHYL PROPYL MAGNESIUM CHLORIDE
Process Description
Stage-1
N, N-Dimethyl proyl amino chloride reacts with magnesium in presence of THF and
Toluene by addition of Catalytic amount of Iodine and EDB.
N, N-DIMETHYL PROPYL MAGNESIUM CHLORIDE
Route of Synthesis
Stage-1
CH3
Cl N CH3
I2 / EDB ClMg N
CH3 + Mg
CH3
THF/Toluene
(3-Chloro-propyl)- 24.31
dimethyl-amine N,N-Dimethyl propyl
C5H12ClN magnesium chloride
C5H12ClMgN
121.61
145.91

Flow Chart
(3-Chloro-propyl)-
dimethyl-amine
Magnesium turnings Stage-1 THF Rec
EDB Toluene Rec
Iodine
THF
Toluene
Material Balance:
Material Balance of N,N-Dimethyl propyl Magnesium chloride

Stage-1
Batch Size:500Kg
in Kg in Kg
(3-Chloro-propyl)-dimethyl- 417.00 N,N-Dimethyl propyl 500.00
amine Magnesium chloride
Magnesium turnings 84.00 THF Recovery 950.00

EDB 1.00 THF Loss 50.00
Iodine 0.20 Toluene Recovery 950.00
THF 1000.00 Toluene Loss 50.00
Total 2502.20 Total 2502.20

13. OMEPRAZOLE
Process Description
Stage-1
3, 5-Lutidine undergoes oxidation with Hydrogen peroxide initially in Acetic acid.

Then the reaction mass will be subjected to Nitration with Nitric acid and Sulphuric
acid mixture. Below is the equation.
Stage-2
Above stage compound on reaction with Sodium methoxide, Sodium Hydroxide and
Dimethyl sulphate in Methanol and water produces stage-2 product. Reaction takes
place as per the equation
Stage-3
A Stage-2 product on reaction with Thionyl chloride, APS and sodium hydroxide
produces stage-3 compound. Toluene is the solvent used in the process. Below is
the equation.
Stage-4
Stage-3 product on condensation with 5-Methoxy -2-Mercapto benzimidazole in

presence of C.S. Lye Produces stage-4.Toluene is the solvent medium
Stage-5
Above stage-4 compound on reaction with Hydrogen Peroxide produces stage-5

pharma. Methanol and Acetone are used in the process.

OMEPRAZOLE
Route of Synthesis:
Stage-1
NO2
N
Acetic acid N
+ H2O2 + HNO3 + 2H2O
3,5-Lutidine Hydrogen Nitric acid 3,5-Dimethyl-4-nitro 2X18=36.0

C7H9N peroxide -pyridine N-Oxide
63.01
107.15 34.01 C7H8N2O3
168.15
.Stage-2
NO2
N Methanol
+ CH3ONa + 2NaOH + (CH3)2SO4
O
3,5-Dimethyl-4-nitro Sodium Sodium hydroxide Dimethyl sulfate
-pyridine N-Oxide methoxide
2X40=80.0 126.13
C7H8N2O3
54.02
168.15
COOH
N + NaNO2 + H 2O + Na2SO4 + CH3OH
O
3,5-Dimethyl-isonicotinic acid 69.0 18.0 142.04 32.0
N-Oxide
C8H9NO3
167.16

Stage-3
O Cl
COOH
N Toluene N
+ SOCl2 + NH4OH
O O
3,5-Dimethyl-isonicotinic acid Thionyl chloride Ammonium
N-Oxide 3,5-Dimethyl-isonicotinoyl
hydroxide
C8H9NO3 118.97 chloride N-Oxide
35.05 C8H8ClNO2
167.16
185.61
+ NH4Cl + H2O + SO2
53.49 18.0 64.06
Stage-4
O Cl
H
N
HS + NH4OH Toluene
N + N O
O
2-Mercapto-5-methoxy Ammonium
3,5-Dimethyl-isonicotinoyl
benzimidazole Hydroxide
chloride N-Oxide
C8H8N2OS 35.05
C8H8ClNO2
180.23
185.61
N
O N CH3
S
N H3C + NH4Cl
H OCH3 + H2O
53.49 18.0
5-Methoxy-2-(4-methoxy-3,5-dimethyl-
pyridin-2-ylmethylsulfanyl)-
1H-benzoimidazole
C17H19N3O2S
329.42

Stage-5
N
O N CH3
S
N Methanol
H3 C OCH3 + H2 O 2
H
5-Methoxy-2-(4-methoxy-3,5-dimethyl-pyridin-2-ylmethylsulfanyl)-1H- Hydrogen peroxide

benzoimidazole
C17H19N3O2S 34.01
329.42
H
N
S N
+ H2 O
O N O
Omeprazole 18.0
C17H19N3O3S
345.42

OMEPRAZOLE
Flow Chart:
Product
3,5-Lutidine
Hydrogen Peroxide Stage-1
Acetic acid 47.3 Kg
Effluent water
Stage-1
Product
Sodium methoxide
Methanol Rec
Sodium hydroxide Stage-2
Dimethyl sulphate 42.5 Kg
Methanol
Effluent water
Product
Stage-2
Toluene Rec
Thionyl Chloride Stage-3
Sodium hydroxide 52.40 Kg
Toluene
Effluent water
Stage-3 Product
2-Mercapto-5-methoxy Benzimidazole Toluene Rec
Stage-4
CS Lye 94.0 Kg
Toluene
Effluent water
Stage-4 Product
Hydrogen peroxide Methanol Rec
Stage-5 Acetone Rec
Methanol
100.0 Kg
Acetone
Effluent water
OMEPRAZOLE

OMEPRAZOLE
Material Balance:
Material balance of Omeprazole

Stage-1
Batch Size:100Kg
in Kg in Kg
3,5-Lutidine 33.00 Stage-1 51.00
Hydrogen Peroxide 11.00 Effluent Water 411.14
Acetic acid 25.00 (Water-400,gen.water- 0
11.14)
Nitric acid 19.50 Acetic acid recovery 25.00
Water 400.00 Organic Residue 1.36

Stage-2
Batch Size:100Kg
in Kg in Kg
Stage-1 51.00 Stage-2 50.00
Sodium methoxide 16.40 Methanol Recovery 475.00
Sodium hydroxide 24.30 Methanol Loss 25.00
Dimethyl sulphate 38.30 Effluent Water 615.17
Methanol 500.00 (Water-600,gen.water-5.45, 0
Methanol-9.72)
Water 600.00 By-Product 64.06
(Sodium Sulphate-43.13, 0
Sodium nitrate-20.93)
Total 1230.00 Total 1230.00


Stage-3
Batch Size:100Kg
in Kg in Kg
Stage-2 50.00 Stage-3 55.00
Thionyl Chloride 36.00 Toluene Recovery 465.00
Ammonium hydroxide 11.00 Toluene Loss 25.00
Water 400.00 (Water-400,gen.water-5.38
Toluene-10)
By-Product 16.80
(Ammonium chloride)
(Sulphur dioxide)

Stage-4
Batch Size:100 Kg
in Kg in Kg
Stage-3 55.00 Stage-5 96.00
2-Mercapto-5-methoxy 53.50 Toluene Recovery 470.00
Benzimidazole
Toluene 500.00 Effluent Water 355.33
Water 350.00 (Water-350,Generated water-
5.33)
By-Product 16.80
(Ammonium chloride-16.8)


Stage-5:Pharma
Batch Size:100 Kg
in Kg in Kg
Stage-4 96.00 Omeprazole 100.00
Hydrogen peroxide 12.00 Methanol Recovery 237.50
Methanol 250.00 Methanol Loss 12.50
Acetone 250.00 Acetone Recovery 237.50
Acetone Loss 12.50
Effluent water 5.25
(Generated Water)

14. PANTOPRAZOLE SODIUM

Process Description
Stage-1
Maltol and Dimethyl sulphate condense in Acetone solvent medium. Excess
Dimethyl sulphate is removed by treating the reaction mass with Potassium
Carbonate. Reaction takes place as per the below equation.
Stage-2
Stage-1 compound on treating with Liquor Ammonia solution stage-2 compound is
formed. Reaction proceeds as per the below equation
Stage-3
Stage-2 compound on reaction with Phosphorous oxy chloride produces stage-3
compound. Further reaction is stopped by treating the reaction mass with water.
Final product is extracted with MDC and after distilling out MDC compound is
obtained. Below is the reaction scheme.
Stage-4
Stage-3 compound when reacts with Hydrogen peroxide in presence of Acetic acid,
stage-4 compound is obtained. Methanol is the solvent employed.
Stage-5
Stage-4 compound on reaction with Methanol in sodium methoxide presence
produces stage-5 compound. Execs Methanol is used. Below is the reaction
Stage-6
Above stage compound on reaction with Acetic anhydride produces an
intermediate.MDC used as solvent. Product is precipitated with C.S. Flakes. Below is
the reaction scheme.
Stage-7
Stage-6 compound when reacts with Sodium hydroxide MDC is used as solvent.
Stage-8
Stage-7 compound when reacts with Thionyl chloride an intermediate is formed.MDC
is used as solvent. Product is crystallized in Methanol. Finally product is purified with
Acetone.
Stage-9
When 2-Chloromethyl-3, 4-dimethoxy-pyridine Hydrochloride reacts with 5-diFluoro
methoxy-2-mercapto-benzimidazole, in presence of Sodium hydroxide, product is
formed. Methylene dichloride is the solvent.
Stage-10
Stage-9 is treated with Sodium hypochlorite in presence of Sodium hydroxide, to
produce the Pantoprazole sodium .This is purified in Acetone. Methylene dichloride
is used as solvent.

PANTOPRAZOLE SODIUM
Route of Synthesis:
Stage-1:
O O
OH OCH3
Acetone
2 + (CH3)2SO4 + K2CO3 2 + K2SO4
O CH3 O CH3
Maltol Dimethyl sulphate 138.21 3-Methoxy-2-methyl- 174.26

pyran-4-one
C6H6O3 126.13 C7H8O3
2X126.11=252.22 2x140.14=280.28
+ CO2 + H2O
44.0 18.0
Stage-2:
O O
OCH3 OCH3
+ (NH4)2CO3 + NH4OH + CO2 + H 2O
O CH3 N CH3
H
3-Methoxy-2-methyl- Ammonium 18.0
3-Methoxy-2-methyl- 35.0 44.0
pyran-4-one carbonate
1H-pyridin-4-one
C7H8O3 96.0 C7H9NO2
140.14 139.15
Stage-3:
O Cl
OCH3 OCH3
MDC
3 + POCl3 3 + H3PO4
N CH3 N CH3
H
4-Chloro-3-methoxy- Phosphoric Acid
3-Methoxy-2-methyl- Phosphorous
2-methyl-pyridine 98.0
1H-pyridin-4-one oxychloride
C7H8ClNO
C7H9NO2 153.33
3X157.60=472.8
3X139.15=417.45

Stage-4:
Cl
Cl OCH3
OCH3
H 2O 2 MeOH N CH3 H 2O
+ +
Acetic acid
N CH3 O
4-Chloro-3-methoxy-2- Hydrogen peroxide 3-methoxy-2-methyl-4- 18.0
methyl-pyridine chloro pyridine-N-oxide
34.01
C7H8ClNO
C7H8ClNO
157.60 173.60
Stage-5:
Cl OCH3
OCH3 OCH3
MeOH
+ CH3ONa + NaCl
N CH3 N CH3
O O
54.02
58.5
3,4-Dimethoxy-2-methyl 3,4-Dimethoxy-2-methyl
pyridine-N-oxide pyridine-N-oxide
C7H8ClNO C8H11NO3
169.18
173.60
Stage-6:
OCH3
OCH3
OCH3
OCH3
MDC
+ (CH3CO)2O + CH3COOH
N CH3 N CH2OCOCH3
O
Acetic acid
Acetic acid 3,4-dimethoxy-
3,4-Dimethoxy-2-methyl Acetic anhydride
pyridin-2-ylmethyl ester 60.0
pyridine-N-oxide C10H13NO4
C8H11NO3
102.09 211.21
169.18

Stage-7
OCH3 OCH3
OCH3 OCH3
MDC CH3COONa
+ NaOH +
N CH2OCOCH3 N CH2OH
(3,4-Dimethoxy-pyridin- Sodium acetate

Acetic acid 3,4-dimethoxy- 40.0 2-yl)-methanol
pyridin-2-ylmethyl ester 82.03
C8H11NO3
C10H13NO4
169.18
211.21
Stage-8:
OCH3
OCH3
OCH3
OCH3
MDC,MeOH HCl + SO2
+ SOCl2
N CH2Cl
N CH2OH
2-Chloromethyl-3,4-dimethoxy- Sulphur dioxide

(3,4-Dimethoxy-pyridin- Thionyl chloride 64.0
pyridine Hydrochloride
2-yl)-methanol 118.97 C8H11Cl2NO2
C8H11NO3
169.18 224.12

Stage-9:
SH
N NH
OCH3
OCH3
O MDC
HCl + + 2 NH4OH
F
N CH2Cl
F
2-Chloromethyl-3,4-dimethoxy- 5-Difluoromethoxy-2- Ammonium
pyridine Hydrochloride mercaptobenzimidazole hydroxide
C8H6F2N2OS 2X35.04=70.08
C8H10ClNO2.HCl
216.21
224.12
OCH3
OCH3
H
N
N CH2 S F
N O 2 H2 O
+ 2 NH4Cl +
F
5-Difluoromethoxy-2-(3,4-dimethoxy- Ammonium chloride 2x18.0=36
pyridin-2-ylmethylsulfanyl)-
1H-benzoimidazole 106.98
C16H15F2N3O3S
367.37

Stage-10:
OCH3
OCH3
H
N
N CH2 S F
N O MDC
+ NaOCl + NaOH
F
Acetone
5-Difluoromethoxy-2-(3,4-dimethoxy- Sodium Sodium
pyridin-2-ylmethylsulfanyl)- hypochlorite hydroxide
1H-benzoimidazole 40.0
C16H15F2N3O3S 74.44
367.37
OCH3
OCH3
O
N
N CH2 S F
N O + NaCl + H 2O
Na F
Sodium chloride 18.0

Pantoprazole sodium
C16H14F2N3NaO4S 58.5
405.35

PANTOPRAZOLE SODIUM
Flow Chart:
Maltol
Dimethyl sulphate Stage-1 Potassium sulfate
Potassium carbonate
Stage-1
Ammonium
Carbonate Stage-2 Toluene Rec
Toluene
Stage-2
Phosphorous
oxy chloride Stage-3 MDC Rec
MDC
Stage-3
Hydrogen peroxide
Acetic acid Stage-4 Methanol Rec
Methanol
Stage-4
Methanol Stage-5 Methanol Rec
Sodium methoxide
Stage-5
Acetic Anhydride Stage-6 Chloroform rec
Chloroform

Stage-6
Sodium hydroxide Stage-7 MDC Rec
MDC
Stage-7
Thionyl chloride
chloroform Stage-8 Chloroform Rec
Stage-8
5-diFluoromethoxy
-2-mercapto- Stage-9 Sodium chloride
benzimidazole
Stage-9
Sodium
hypochlorite Stage-10 Sodium chloride
Sodium
Hydroxide
PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM
Material Balance:
Material Balance of Pantoprazole Sodium

Stage-1
Batch Size: 200 Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
Maltol 66.00 Stage-1 73.00
Dimethyl sulphate 33.00 Acetone Recovery 378.00
Potassium carbonate 36.00 Acetone Loss 20.00
Acetone 400.00 Generated water 4.70
(Carbon dioxide)
By-Product 45.60
(Potassium Sulphate)
Acetone-2)

Stage-2
Batch Size: 200Kg
in Kg in Kg
Stage-1 73.00 Stage-2 72.00
Ammonium Carbonate 50.00 Toluene Recovery 280.00
Toluene 300.00 Toluene Loss 15.00
(Water-600,Ammonium 0
hydroxide-18.2
,Generated water-
9.37,Toluene-2)
(Organic Impurities-0.53, 0
Toluene-3)
(Carbon dioxide)
Total 1023.00 Total 1023.00


Stage-3
Batch Size: 200Kg
in Kg in Kg
Stage-2 72.00 Stage-3 79.00
Phosphorous oxy chloride 26.00 MDC Recovery 285.00
Ammonia 9.00 MDC Loss 15.00
Methylenedichloride 300.00 Effluent Water 600.00
Water 600.00 (Water-600) 0
By-Product 26.30
(Ammonium phosphate) 0
Total 1007.00 Total 1007.00

Stage-4
Batch Size: 200Kg
in Kg in Kg
Stage-3 79.00 Stage-4 87.00
Hydrogen peroxide 17.00 MDC Recovery 668.00
Acetic acid 30.00 MDC Loss 30.00
Sodium Hydroxide 20.00 Methanol Loss 12.50
MDC 700.00 Effluent Water 419.50
Water 400.00 (Water-400, Generated
water-17, Methanol-2.5)
By-Product 41.00
(Sodium acetate)
Organic Solid Waste 5.00
1,MDC-2,Methanol-2)
Total 1496.00 Total 1496.00


Stage-5
Batch Size: 200 Kg
in Kg in Kg
Stage-4 87.00 Stage-5 85.00
Sodium methoxide 27.00 Methanol Loss 20.00
Acetic Acid 10.00 Effluent Water 642.20
Water 600.00 (Water-600, Sodium 0
Chloride-29.2,Methanol-
3,Acetic acid-10)
Total 1224.00 Total 1224.00

Stage-6
Batch Size: 200Kg
in Kg in Kg
Stage-5 85.00 Stage-6 106.00
Acetic Anhydride 172.00 Chloroform Recovery 190.00
Chloroform 200.00 Chloroform Loss 10.00
Water 400.00 Acetic acid Recovery 101.00
Effluent Water 400.00
(Water-400) 0


Stage-7
Batch Size: 200Kg
in Kg in Kg
Stage-6 106.00 Stage-7 85.00
MDC 200.00 MDC Recovery 190.00
Sodium hydroxide 20.00 MDC Loss 10.00
(Water-200)
By-Product 41.00
(Sodium acetate)

Stage-8
Batch Size: 200Kg
in Kg in Kg
Stage-7 85.00 Stage-8 (Chloro 112.00
compound)
Thionyl chloride 60.00 Chloroform Recovery 810.00
Chloroform 850.00 Chloroform Loss 40.00
Acetone 200.00 Methanol Loss 25.00
Acetone Recovery 189.00
Acetone Loss 10.00
(Sulphur Dioxide)
(Organic Impurities-1,
Methanol-1,Acetone-1)
Total 1320.00 Total 1320.00


Stage-9
Batch Size: 200Kg
in Kg in Kg
Stage-8 112.00 Stage-9 183.00
5-diFluoromethoxy-2-mercapto- 108.00 Toluene Recovery 472.00
benzimidazole
Water 600.00 (Water-600, gen.Water- 0
18, Toluene-1.5)
B-Product 54.19
(Ammonium chloride) 0
Toluene-1.5)
Total 1355.50 Total 1355.50

Stage-10:Pharma
Batch Size: 200Kg
in Kg in Kg
Stage-8 183.00 Pantoprazole Sodium 200.00
Sodium hypochlorite 37.00 MDC Recovery 950.00
Sodium Hydroxide flakes 20.00 MDC Loss 50.00
Ammonium Chloride 25.00 Acetone Recovery 378.00
Methylene dichloride 1000.00 Acetone Loss 20.00
Activated Carbon 10.00 Effluent Water 465.00
Acetone 400.00 (Water-400,gen.water-9, 0
Sodium chloride-29,
Aluminum chloride-25,
Acetone-2)
Water 400.00 Spent carbon 10.00
Total 2075.00 Total 2075.00

15. PHENYL MAGNESIUM CHLORIDE
Process Description
Stage-1
temperature. Start and continue the addition of Chlorobenzene up to completion of
the reaction. Maintain for few hours and cool to room temperature. Check Product
and unload the material into the containers under nitrogen atmosphere.
PHENYL MAGNESIUM CHLORIDE
Route of Synthesis:
Stage-1:
Cl MgCl
THF
Mg +
Magnesium Chlorobenzene Phenyl Magnesium chloride

24.31 C6H5Cl C6H5ClMg
112.56 136.86

Flow Chart:
Chlorobenzene
Stage-1 THF Recovery
Magnesium turnings
THF
Material Balance:
Material Balance of phenyl Magnesium Chloride

Stage-1
in Kg in Kg
Phenyl Magnesium Chloride in 1750.00
Chlorobenzene 820.00
THF Solution
Magnesium turnings 180.00 THF Loss 50.00
THF 800.00
Total 1800.00 Total 1800.00

16. QUETIAPINE FUMARATE
Stage-1
2-Aminbiphenylsulphate when reacts with Phenyl chloro fumarate, the compound is

formed. Toluene is the solvent .Toluene layer is washed with water to remove acidic
salts that form during the reaction.
Stage-2
Stage-1 compound is hydrolyzed in presence of Phosphoric acid to obtain the stage-

2 compound. Acetone wash is given to remove water traces.
Stage-3
Stage-2 compound made to react with Piperazine in Toluene medium to produce the
stage -3 compound.
Stage-4
Stage-3 is converted to pharma by treating with Chloro ethoxy ethanol and Fumaric
acid in Toluene medium. Toluene layer is washed with water to remove water
soluble impurities. Finally the pharma is re-crystallized in Methanol.

QUETIAPINE FUMARATE
Route of synthesis:
Stage-1:
-O O
O
Cl
O S O
O Toluene
+ -O O
NH2
2-Aminodiphenyl sulphate Phenyl chloro fumarate
C12H11NO4S C10H5ClO4
224.60
265.29
NH O O Cl
S
OH + CO2
+ HO O
Phenyl-2-(phenyl carbamate Hydroperoxy-hydroxy Carbondioxide

-acetyl chloride 44.01
C19H15NO2S
C2HClO4
321.39
124.48

Stage-2:
O
OH
NH O HN
S
Phosphoric acid
+ H2 S
Dibenzo,1,4-thiozepin,1-H-one
Phenyl-2-(phenyl carbamate Hydrogen
C13H11NOS
C19H15NO2S 2.00
229.30
321.39
OH
Phenol
C6H6O
94.11
Stage-3:
NH
OH
HN H N
N
Toluene
+ HN NH
S + H 2O
S
Dibenzo,1,4-thiozepin Piperazine 11-Piperazin-1-yl-5a,9a,10,11 18.00

1-H-one -tetrahydro-dibenzo[b,f]
C4H10N2
C13H11NOS [1,4]thiazepine
86.14 C17H19N3S
229.30 297.42

Stage-4:
Step-A
NH
H N
N
O Toluene
S + HO Cl
11-Piperazin-1-yl-5a,9a,10,11 2-(2-Chloro-ethoxy)-ethanol
-tetrahydro-dibenzo[b,f] C4H9ClO2
[1,4]thiazepine
C17H19N3S 124.57
297.42
O
N Cl
H N
N
+ H2 O
S
11-{4-[2-(2-Chloro-ethoxy)-ethyl]-piperazin 18.00
-1-yl}-10,11-dihydro-dibenzo[b,f]
[1,4]thiazepine
C21H26ClN3OS
403.97

Step-B
O
N
Cl O OH
H N
N
+ HO O
S
Fumaric acid
11-{4-[2-(2-Chloro-ethoxy)-ethyl]-piperazin
-1-yl}-10,11-dihydro-dibenzo[b,f] C4H4O4
[1,4]thiazepine
C21H26ClN3OS 116.07
403.97
Toluene
O
N OH
O Cl
H N
N +
HO O
S
Chloro fumaric acid

Quetiapine
C4H3ClO3
C21H27N3O2S
134.52
385.52

Step-C
O
N OH
H N O OH
N
S
+ HO O
2
Fumaric acid
Quetiapine
C42H50N6O4S2 C 4 H4 O 4
2X385.52=770.00 116.07
O
N OH
N O OH
H
N
S HO O
2
Quetiapine fumarate
C46H54N6O8S2
886.07

QUETIAPINE FUMARATE
Flow Chart:
2-Aminbiphenylsulphate
Phenyl chloro fumarate Stage-1 Toluene Rec
Toluene
Stage-1
phosphoric acid Stage-2 Acetone Rec
Acetone
Stage-2
Piperazine Stage-3 Toluene Rec
Toluene
Stage-3
Chloro ethoxy ethanol Stage-4 Methanol Rec
Fumaric acid
Methanol.
QUETIAPINE FUMARATE

QUETIAPINE FUMARATE
Material Balance:
Material Balance of Quetiapine fumarate

Stage-1
Batch Size: 200Kg
in Kg in Kg
2-Aminbiphenylsulphate 140.00 Stage-1 165.00
Phenyl chloro fumarate 118.50 Toluene Recovery 378.00
(Water-200,Chloro-oxo
ethane peroxic acid-65.6,
Toluene-1)
(Carbon dioxide)
Toluene-1)

Stage-2
Batch Size: 200Kg
in Kg in Kg
Stage-1 165.00 Stage-2 115.00
phosphoric acid 46.70 Acetone Recovery 372.00
Hydrogen gas 1.02 Effluent Water 324.80
Water 250.00 (Water-250,Acetic Acid-
20.1,Acetone-8,Phosphoric
Acid-46.7)
Phenol Recovery 30.92


Stage-3
Batch Size: 200Kg
in Kg in Kg
Stage-2 115.00 Stage-3 140.00
Piperazine 44.00 Toluene Recovery 332.00
Gen. Water 9.02
Toluene-1)

Stage-4 Pharma
Batch Size: 200Kg
in Kg in Kg
Stage-3 140.00 Quetiapine fumarate 200.00
Chloro ethoxy ethanol 59.00 Toluene Recovery 380.00
Fumaric acid 85.00 Toluene Loss 20.00
Methanol. 400.00 Methanol Recovery 377.00
Toluene 400.00 Methanol Loss 20.00
(Water-800,gen.water-8.46,
Methanol-2, Chloro fumaric acid-
63.3)
Methanol-1)
Total 1884.00 Total 1884.00

17. RABEPRAZOLE SODIUM
Process Description
Stage-1
2, 3-Lutidine is reacted with Hydrogen Peroxide in presence of Acetic Acid to give N-

Oxide it further reacts with Nitration mixture (Nitric Acid + Sulfuric Acid) to give
Stage-1
Stage-2
Stage-1 is reacted with 3-Methoxy-1-Propanol and Sodium Hydroxide to get Stage-2

Compound
Stage-3
Stage-2 Compound is reacted with Acetic Anhydride, Sodium Hydroxide and

Hydrochloric Acid to get Stage-3 Compound
Stage-4
Stage-3 Compound is reacted with Thionyl Chloride, 2Mercapto benzimidazole and

sodium hydroxide in the presence of MDC as a solvent media to give stage-4 as
product.
Stage-5
Stage-4 Compound is reacted with Sodium Hypochlorite to get Rabeprazole Base
Stage-6
Stage-5 reacts with Sodium hydroxide to get Rabeprazole Sodium

RABEPRAZOLE SODIUM
Route of Synthesis:
Stage-1:
NO2
CH3 CH3
H2SO4 2H2O
H2O2 + +
+ HNO3
N CH3 N CH3
O
2,3-Lutidine Hydrogen 4-Nitro-2,3-Dimethyl
Niric acid pyridine-N-oxide 36.0
C7H9N peroxide
34.01 63.0 C7H8N2O3
107.15
168.15
Stage-2:
O O
NO2
H3C
CH3
+ HO O + NaOH H3C N+
N CH3
O-
O
4-Nitro-2,3-Dimethyl 3-Methoxy-1-Propanol 4(3-Methoxy propoxy)-2,3-
40.0
pyridine-N-oxide C4H10O2 Dimethyl pyridine-N-oxide
C7H8N2O3 90.12 C11H17NO3
168.15 211.26
+ NaNO2 + H2 O
Sodium Nitrite 18.0

69.0

Stage-3:
O O
H 3C
(CH3CO)2O + HCl
+ NaOH
H3C N+ +
36.5
O- 40.0
4(3-Methoxy propoxy)-2,3 Acetic Anhydride
-Dimethyl pyridine-N-oxide 102.0
C11H17NO3
211.26
O O
Cl
H CH3COONa + CH3COOH
HO +
N
82.0 60.0
4(3-methoxy propoxy)-2-hydroxy
methyl -3-methyl pyridine
hydrochloride
C11H17NO3 HCl
247.72
Stage-4:
O O O O
Cl
+ SO2
H + SOCl2 Cl
HO N
N 64.0
Thionyl 4-(3-methoxy-propoxy)-2-
4(3-methoxy propoxy)-2-hydroxy
Chloride Chloromethyl-3-methyl-
methyl -3-methyl pyridine
Pyridine
hydrochloride 118.97 C11H16ClNO2
C11H17NO3 HCl
247.72 229.7
+ 2 HCl
2X36.5=73

Stage-5:
O O
H
N
Cl + HS + NH4OH
N N
4-(3-methoxy-propoxy)-2- 2-Mercapto benzimidazole 35.05

Chloromethyl-3-methyl- C7H6N2S
pyridine 150.25
C11H16ClNO2
229.7
O O
N
S C N
N H2 + NH4Cl + H2 O
H
2-[4-(3-Methoxy-propoxy)-3-methyl-pyridin- 53.49 18.0
2-ylmethylsulfanyl]-1H-benzoimidazole
C18H21N3O2S
343.44

Stage-6:
O O
O O
O
N
N
NaOCl S C N
S C N + H2
N H2 N
H H
2-[4-(3-Methoxy-propoxy)-3-methyl- Sodium 2-[4-(3-Methoxy-propoxy)-3-methyl-

pyridin-2-ylmethylsulfanyl]- Hypochlorite pyridin-2-ylmethanesulfinyl]-
1H-benzoimidazole 1H-benzoimidazole
C18H21N3O2S 74.44 C18H21N3O3S
343.44 359.44
+ NaCl
58.5
Stage-7:
O O O O
O O
N N
S C N + NaOH S CH N + H 2O
N H2 N
H H Na
2-[4-(3-Methoxy-propoxy)-3-methyl- 40.0 Rabeprazole Sodium

pyridin-2-ylmethanesulfinyl]- C18H20N3NaO3S 18.0
1H-benzoimidazole
381.42
C18H21N3O3S
359.44

RABEPRAZOLE SODIUM
Flow Chart:
2,3 Lutidine
Hydrogen peroxide Stage-1 Generated water
Nitric acid
Stage-1
3-Methoxy-1-propanol Stage-2 Sodium nitrite
Sodium hydroxide
Stage-2 Sodium acetate

Stage-3
3-Methoxy-1-propanol
Acetic anhydride
Stage-3 Stage-4 Sulphur dioxide

Thionyl chloride
Stage-4 Sodium chloride

Stage-5
2-mercaptobenzimidazole
Stage-5 Stage-6 Sodium chloride

Sodium hypochlorite
Stage-6 Stage-7 Generated water

Sodium hydroxide
RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM
Material Balance:
Material balance of Rabeprazole Sodium

Stage-1
Batch Size: 100Kg
in Kg in Kg
2,3-Lutidine 46.00 Stage-1 65.00
Hydrogen Peroxide (50%) 33.00 Effluent Water 350.80
Nitric acid 38.00 (Water-300 ,Acetic Acid- 0
6,Hydrogen Peroxide-
1.9,Nitric Acid-10.9, gen.
water-15.5,Water from
Hydrogen peroxide-16.5)
Acetic acid 6.00 Organic Residue 7.20
Water 300.00

Stage-2
Batch Size: 100Kg
in Kg in Kg
Stage-1 65.00 Stage-2 80.00
3-Methoxy-1-Propanol 43.00 Toluene Recovery 235.00
Sodium Hydroxide 15.50 Toluene Loss 12.00
Toluene 250.00 DMSO Recovery 188.00
DMSO 200.00 DMSO Loss 10.00
Generated water 7.00
By-Product 29.70
(Sodium Nitrite-29.7)
Toluene-3,DMSO-2)


Stage-3
Batch Size: 100Kg
in Kg in Kg
Stage-2 80.00 Stage-3 90.00
Acetic anhydride 39.00 Toluene Recovery 660.00
Sodium Hydroxide 15.00 Toluene Loss 35.00
Hydrochloric acid 20.00 Effluent Water 302.00
Toluene 700.00 (Water-300, Toluene-2)
Water 300.00 Acetic Acid Recovery 25.20
By-Product 34.50
(Sodium Acetate)
4.3,Toluene-3)
Total 1154.00 Total 1154.00

Stage-4
Batch Size: 100Kg
in Kg in Kg
Stage-3 90.00 Stage-4 80.00
Thionyl Chloride 53.00 MDC Recovery 710.00
MDC 750.00 MDC Loss 37.00
Sodium Sulphate 10.00 Effluent Water 426.50
Water 400.00 (Water-400,Hydrochloric
acid-26.5)
Inorganic Solid Waste 10.00
(Sodium Sulphate)
(Organic Impurites-13.3,
MDC-3)
(sulfur dioxide)
Total 1303.00 Total 1303.00


Stage-5
Batch Size: 100Kg
in Kg in Kg
Stage-4 80.00 Stage-5 100.00
2-Mercaptobenzimidazole 53.00 Toluene Recovery 375.00
Water 300.00 (Water-300, generated
water-6.42,Toluene-2)
By-Product 19.07
(Ammonium chloride)
(Organic Impurites-
20.01, Toluene-3)

Stage-6
Batch Size: 100Kg
in Kg in Kg
Stage-5 100.00 Stage-6 100.00
Sodium Hypochlorite (8%) 327.00 MDC Recovery 570.00
MDC 600.00 MDC Loss 30.00
Acetone 150.00 Acetone Recovery 137.00
Sodium hydro sulphate 12.00 Acetone Loss 10.00
MMA in Methanol 10.00 Effluent Water 1344.30
Water 1000.00 (Water-1000,Sodium 0
Chloride-17,water from
sodium hypochlorite-
300,Sodium
Hypochlorite-5.3,MMA-
10, Sodium
hydrosulphate-12)
(Organic Impurities-4.7, 0
Acetone-3)
Total 2199.00 Total 2199.00


Stage-7:Pharma
Batch Size: 100Kg
in Kg in Kg
Stage-6 100.00 Rabeprazole Sodium 100.00
Sodium Hydroxide 13.00 IPA Recovery 280.00
Isopropyl Alcohol 300.00 IPA Loss 15.00
Activated Carbon 10.00 Generated water 5.00
Spent carbon 10.00
8,IPA-5)

18. SODIUM METHOXIDE
Process Description
Stage-1
Sodium hydroxide reacts with Methanol to give sodium methoxide,by eliminating

water.
SODIUM METHOXIDE
Route of Synthesis
Stage-1
NaOH + CH3OH CH3ONa + H2 O
Sodium hydroxide Methanol Sodium methoxide 18.02

40.00 32.04 54.02
SODIUM METHOXIDE
Flow Chart
Sodium hydroxide Stage-1 Methanol Rec

Methanol
SODIUM METHOXIDE

SODIUM METHOXIDE
Material Balance:
Material Balance of Sodium methoxide

Stage-1
Batch Size:2000Kg
in Kg in Kg
Sodium hydroxide 1482.00 Sodium methoxide in Methanol 2000.00
Methanol Loss 38.00
Generated water 668.00
Total 3182.00 Total 3182.00

19. SODIUM TERT BUTOXIDE
Process Description
Stage-1
Sodium is added into excess tert-butanol in a rotary drier cum reactor. Excess Tert-
Butanol is used to ensure the complete reaction of the corresponding metals. Then
the excess Tert-Butanol is recovered by thermic fluid heating through a condensor
and used again in the next batches. A small quantity of hydrogen is let out through a
liquid paraffin trap.
SODIUM TERT BUTOXIDE
Route of Synthesis
Stage-1:
CH3 CH3
H3C OH H3C ONa 1/2 H2

Na + +
CH3 CH3
Sodium metal Tert-Butanol Sodium tert-butoxide Hydrogen gas

C4H10O C4H9ONa 1/2X2=1.00
22.99
74.12
96.10

Flow Chart:
Sodiummetal Hydrogen gas

Stage-1
Tert-Butanol Tert-Butanol Rec
SODIUM TERT- BUTOXIDE
Material Balance:
Material Balance of Sodium tert-Butoxide

Stage-1
Batch Size:500.0 Kgs
in Kg in Kg
Sodium 141.18 Sodium tert-Butoxide 500.00
Tert-Butanol 650.00 t-Butanol Recovery 271.25
t-Butanol Loss 15.48
(Hydrogen-4.45)

20. TELMISARTAN
Process Description
Stage-1
Step-A
Methyl-4-(butyramido)3-methyl-5-nitrobenzoate undergoes hydrogenation in the
presence of Palladium carbon as catalyst by using Methanol as solvent media to
give Stage-1A as product.
Step-B
Stage-1A product reacts with sodium hydroxide and hydrochloric acid to give Stage-
1B as product.
Stage-2
Stage-1 B product reacts with N-Methylbenzene-1,2-diamine in the presence of

Sodium hydroxide and polyphosphoric acid to give Stage -2 as product.
Stage-3
Stage-2 product reacts with 1, 3-dibromo-5, 5-dimethylimidazolidine-2,4-dione in the

presence of Chloroform as solvent media to give Stage-3 as product.
Stage-4
Stage-2 product reacts with Stage-3 and potassium hydroxide in the presence of
acetone as solvent media to give Stage-4 as product.
Stage-5
Stage-4 product reacts with potassium hydroxide and hydrochloric acid in the
presence of MDC as solvent media to give stage-5 as product.
Stage-6
Stage-5 product undergoes purification with Methanolic ammonia, acetic acid and
activated carbon in the presence of methanol as solvent media to give Telmisartan
as product.

TELMISARTAN
Route of Synthesis:
Stage-1
Step-A
NH NH
Pd/C
O + H2 H3CO O + O2
H3 CO NH2
NO2 MeOH
O O
methyl-4-(buytramido)-3-methyl Hydrogen Methyl-3-amino-4-(buytramido) Oxygen
-5-nitrobenzoate 2.0 -5-methylbenzoate
C13H16N2O5 C13H18N2O3 32.0
280.28 250.29
Step-B
NH
O + NaOH + HCl
H3CO
NH2
O
Methyl-3-amino-4-(buytramido) Sodium Hydrochloric
-5-methylbenzoate hydroxide acid
C13H18N2O3 40.0 36.5
250.29
OH
N
H + CH3OH + NaCl + H2O
O
7-Methyl-2-propyl-3H-benzoimidazole- Methanol Sodium chloride Water

5-carboxylic acid 58.5 18.0
32.0
C12H14N2O2
218.25

Stage-2
N
N NH
PPA N
OH + NaOH N
N
H NH2 N
O H
7-Methyl-2-propyl-3H-benzoimidazole- N-Methylbenzene- 4-Methyl-6-(1-methyl-1H-benzoimidazol
5-carboxylic acid 1,2-diamine -2-yl)-2-propyl-1H-benzo imidazole
C12H14N2O 2 C7H10N2
C19H20N4
218.25 122.17
304.39
+ 2H2O
36.0
H3PO4 + 3 NaOH Na3PO4 + 3 H2 O
Phosphoric Acid Sodium hydroxide Sodium phosphate Water
98.0 3X40=120 163.94 3X18=54
Stage-3
H3C O
COOCH3 BrH2C
COOCH3
Br N Chloroform
+
N
Br
O
methyl-4-methyl-1,1-biphenyl- 1,3-Dibromo-5,5-dimethyl
2-carboxylate 4-(bromomethyl)biphenyl-2-
imidazolidine-2,4-dione
C15H14O2 carboxylic acid methyl ester
C5H6N2O2 C15H13 BrO2
226.27 285.92 305.17
+
HN
N
Br
O
1-Bromo-5,5-dimethyl
C5H7BrN2O2
207.03

Stage-4
N BrH2C
COOCH3
N
N + Acetone
+ KOH
N
H
4-Methyl-6-(1-methyl-1H-benzoimidazol 4-(bromomethyl)biphenyl Potassium

-2-yl)-2-propyl-1H-benzo imidazole -2-carboxylic acid methyl ester hydroxide
C19H20N4 C15H13BrO2 56.11
304.39 305.17
N
N
N
+ KBr + H2O
COOCH3
methyl-4-[[2n-propyl-4-methyl-6-(1-methylbenzimidazole-2-yl)- 119.0 18.0

benzimidazole-1-yl]-methyl]biphenyl carboxylate
C34H32 N4O2
528.64

Stage-5
N
N
N
MeOH
+ KOH + HCl
COOCH3
methyl-4-[[2n-propyl-4-methyl-6-(1-methylbenzimidazole-2-yl)- Potassium Hydrochloric

benzimidazole-1-yl]-methyl]biphenyl carboxylate hydroxide acid
C34H32N4O2 56.11 36.5
528.64
N
N
+ CH3 OH + KCl
N
COOH
4-[[2n-Propyl-4-methyl-6-(1-methyl benzimidazole-2-yl) 32.0 74.55

-benzimidazole-1-yl]-methylbiphenyl carboxylic acid
C33H30N4O2
514.62

Stage-6
N
N
N
MeOH
+ CH3OH NH3 + CH3COOH
COOH
4-[[2n-Propyl-4-methyl-6-(1-methyl benzimidazole-2-yl) Methanolic Acetic acid

-benzimidazole-1-yl]-methylbiphenyl carboxylic acid ammonia
60.0
C33H30 N4O2 CH7NO
514.62 49.07
N
N
N
+ CH3COONH4 + CH3OH
COOH
Telmisaratn Ammonium acetate Methanol

C33 H30N4O2 77.08 32.0
514.62

TELMISARTAN
Flow chart:
Methyl-4-(butyramido)-3- Product
methyl-5-nitrobenzene Methanol Rec
Methanol Stage-1
Palladium carbon(Wet 5% MC) 55.0 Kg
Sodium hydroxide Effluent water
Hydrochloric acid
Stage-1 Product
N-Methylbenzene-1,2-diamine Stage-2
Poly phosphoric acid 73.0 Kg
Sodium hydroxide
Effluent water
Methyl-4-methyl-1,1-biphenyl-
2-carboxylate Product
1,3-dibromo-5,5-dimethyl n-Hexane Rec
Stage-3
Sodium meta bisulphate 73.50 Kg
Chloroform Effluent water
n-Hexane
Product
Stage-2 Acetone Rec
Stage-4
Stage-3 123.0 Kg
Potassium hydroxide
Acetone Effluent water
Stage-4 Product
Potassium hydroxide Carbon Dioxide
Stage-5
MDC 115.0 Kg
Methanol
Hydrochloric acid (20%) Effluent water
Stage-5 Product
Methanolic ammonia Methanol Rec
Stage-6
Acetic acid
100.0 Kg
Methanol
Effluent water
TELMISARTAN

TELMISARTAN
Material Balance:
Material Balance of Telmisartan

Stage-1
Batch Size: 100Kg
in Kg in Kg
Methyl-4-(butyramido)-3- 73.00 Stage-1 55.00
methyl-5-nitrobenzene
Palladium carbon(Wet 5% MC) 3.00 Methanol Loss 43.00
Sodium hydroxide 10.40 Effluent water 550.20
Hydrochloric acid 31.60 (Water-500,generated water-4.6,
Sodium chloride-15.2,Hydrochloric
acid-22.1, Methanol-8.3)
Water 500.00 Palladium Carbon Reuse 3.00
(Oxygen)
Total 1483.00 Total 1483.00

Stage-2
Batch Size: 100Kg
in Kg in Kg
Stage-1 55.00 Stage-2 73.00
N-Methylbenzene-1,2-diamine 32.00 Effluent Water 658.67
Phosphoric acid 90.00 (Water-600,generated water-58.67)
Sodium hydroxide 110.20 By-Product 150.56
Water 600.00 (Sodium Phosphate)


Stage-3
Batch Size: 100Kg
in Kg in Kg
Methyl-4-methyl-1,1-biphenyl- 57.00 Stage-3 73.50
2-carboxylate
1,3-dibromo-5,5-dimethyl 72.00 Chloroform Recovery 304.00
Azo bis isobutyronitrile 2.90 Chloroform Loss 16.00
Sodium meta bisulphate 4.30 n-Hexane Recovery 95.00
Chloroform 320.00 n-Hexane Loss 5.00
n-Hexane 100.00 Effluent water 407.20
Water 400.00 (Water-400,Sodium meta
bisulphate-4.3,Azobis
isobutyronitrile-2.9,)
By-Product 52.13
(1-Bromo-5,5-dimethyl imidazoline-
2,4-dione)

Stage-4
Batch Size: 100Kg
in Kg in Kg
Stage-2 73.00 Stage-4 123.00
Stage-3 73.50 Acetone Recovery 427.00
Potassium hydroxide 18.00 Acetone Loss 22.00
Acetone 450.00 Effluent water 939.30
Water 900.00 (Water-900,generated water-4.3,
Potassium hydroxide-4.5,Acetone-
2,Potassium bromide-28.5)
(Organic Impurities-2.2,Acetone-1)
Total 1514.50 Total 1514.50


Stage-5
Batch Size: 100Kg
in Kg in Kg
Stage-4 123.00 Stage-5 115.00
Potassium hydroxide 15.00 MDC Recovery 1138.00
MDC 1200.00 MDC Loss 60.00
Hydrochloric acid (20%) 50.00 Methanol Loss 50.00
Acetic acid 40.00 Effluent water 706.20
Activated carbon 5.00 (Water-600,Potassium chloride-
17.3,Methanol-7.4,Acetic acid-40,
water from HCl-40,Hydrochloric
acid-1.5)
Water 600.00 Spent Carbon 5.00
(Organic Impurities-6.8, Methanol-
2,MDC-2)
Total 3033.00 Total 3033.00

Stage-6
Batch Size: 100Kg
in Kg in Kg
Stage-5 115.00 Telmisartan 100.00
Methanolic ammonia 50.00 Methanol Recovery 833.00
Acetic acid 20.00 Methanol Loss 40.00
Methanol 830.00 Effluent water 234.40
Activated carbon 5.00 (Water-230,Acetic acid-2.4,
Methanol-2)
By-Product
(Ammonium acetate) 22.70
Water 230.00 Spent Carbon 5.00
Total 1243.00 Total 1243.00

Annexure - III
WATER CONSUMPTION DETAILS
Water
S. No Purpose Requirement
In KLD
1 Process 49.82
2 Washings 2.00
3 Boiler Make up 58.50
4 Cooling towers Make up 144.50
5 DM Plant 2.00
6 Scrubbing system 2.00
7 Domestic usage 2.00
8 Gardening 5.00
Total 266.0

Annexure - IV
HAZARDOUS WASTE DETAILS
Name of the Quantity

S. No Disposal Method
Hazardous Waste Kg/Day
1 Organic waste 1254.00 Sent to Cement Industries
2 Spent Carbon 146.00 Sent to Cement Industries
3 Solvent Distillation Residue 176.00 Sent to Cement Industries
4 Inorganic Waste 279.00 Sent to TSDF
5 MEE Salts 5990.0 Sent to TSDF
6 ETP Sludge 50.00 Sent to TSDF
7 800 SPCB Authorized Agencies
Used Oils
L/Annum for Reprocessing/Recycling
8 After Detoxification sent
600 No’s /
Detoxified Containers back to suppliers/SPCB
Month
Authorized Parties
9 4 No’s/ Send back to suppliers for
Used Lead Acid Batteries
Annum buyback of New Batteries
Solid Waste Details
10 Coal ash from boiler 11750 Sent to Brick Manufacturers

Annexure - V
STACK EMISSIONS FOR PROPOSED BOILERS
10.0 TPH Coal fired 6.0 TPH Coal

Particulars Units Boiler fired Boiler
(Proposed) (Stand By )
Type of Fuel -- Indian Coal Indian Coal
Coal Consumption TPD 25.0 15.0
Ash Content % 47 47
Sulphur Content % 0.8 0.8
Nitrogen Content % 1.07 1.07
No. of Stacks No 1 1
Height of stack M 32 30
Diameter of Stack M 0.80 0.60
o
Temperature of Flue Gas C 140 110
Velocity of Flue Gas m/s 8.50 8.50
Particulate Matter at outlet of gm/sec
Bag filter (Based on 115 0.74 0.62
mg/Nm3 at outlet)
Sulphur dioxide emission gm/sec 2.31 1.39
Oxides of Nitrogen emission gm/sec 3.01 1.86
Cyclone separator
Cyclone separator
followed by
followed by suitable
Pollution control equipment - suitable pack of
pack of Bag filters
Bag filters
6 TPH Coal fired boiler is kept as stand by
STACK EMISSION DETAILS FOR EXISTING & PROPOSED DG SETS
Emission Emission Emission Stack Flue Gas Stack Flue gas

Capacity
of SPM in Of SO2 in of NOx In dia. Temp. in Height Velocity
In KVA
mg/Nm3 mg/Nm3 mg/Nm3 In m O
C in m In m/sec.
275 KVA 67.0 118.0 140.0 0.25 200 10 18.50
(Existing)
500 KVA
80.0 190.0 235.0 0.30 220 12 23.20
(Existing)
275KVA 67.0 118.0 140.0 0.25 200 10 18.50
(Proposed)

Annexure - VI
EXPECTED PROCESS EMISSION DETAILS
Quantity
S. No Name of the Gas In Treatment Method
Kg/Day
Polluting Process Emission Details
1 Ammonia 95.00 Scrubbed by using chilled water media
2 Sulphur dioxide 248.00 Scrubbed by using C. S. Lye solution
Non- Polluting Process Emission Details
1 Carbon dioxide 150.00 Dispersed into atmosphere
2 Oxygen 8.00 Dispersed into atmosphere
30.00 Diffused by using Nitrogen through
3 Hydrogen
Flame arrestor
103.00 Dispersed into atmosphere through
4 Methane
Nitrogen

Annexure - VII
LIST OF RAW MATERIALS
1. BENZYL MAGNESIUM CHLORIDE
Used /Batch in Used/ Day in

S. No Raw Material Source
Kgs Kgs
1 Magnesium 160.00 53.33 Indigenous
2 Benzyl chloride 840.00 280.00 Indigenous
3 Diethyl ether 770.00 256.67 Indigenous
4 Tetrahydrofuran 1100.00 366.67 Indigenous
2. BUTYL MAGNESIUM CHLORIDE

Kgs Kgs
1 Magnesium Metal 210.00 105.00 Indigenous
2 Butyl Chloride 790.00 395.00 Indigenous
3 THF 805.00 402.00 Indigenous
3. DOMPERIDONE
Used /Batch Used/ Day in

in Kgs Kgs
1 N-Carbethoxy-4-piperidone 80.00 266.67 Indigenous
1-(3-Chloropropyl)-1,3-
2 dihydro-2H- 40.00 133.33 Indigenous
benzimedazole-2-one
3 2,5-Dichloro Nitrobenzene 78.00 260.00 Indigenous
4 Ammonia gas 28.00 93.33 Indigenous
5 Hydrogen 10.00 33.33 Indigenous
6 Methanol 800.00 2666.67 Indigenous
7 Methyl Isobutyl Ketone 1200.00 4000.00 Indigenous
8 Raney Nickel 30.00 100.00 Indigenous
9 Sodium Carbonate 50.00 166.67 Indigenous
10 Sodium Hydroxide 75.00 250.00 Indigenous
11 Toluene 350.00 1166.67 Indigenous
12 Urea 20.00 66.67 Indigenous

4. ESCITALOPRAM OXALATE

Kgs Kgs
1 Bromo phthalide 110.00 110.00 Indigenous
2 Acetic acid 121.00 121.00 Indigenous
3 Acetone 1724.00 1724.00 Indigenous
4 Activated carbon 80.30 80.30 Indigenous
5 Ammonia Liq 204.00 204.00 Indigenous
6 Caustic flakes 38.30 38.30 Indigenous
7 Copper cyanide 45.00 45.00 Indigenous
8 Copper iodide 57.00 57.00 Indigenous
Dimethyl amino propyl
9 76.00 76.00 Indigenous
magnesium chloride
10 DMF 2288.00 2288.00 Indigenous
11 Ethylene di amine 267.00 267.00 Indigenous
12 Fluoro bromo benzene 103.00 103.00 Indigenous
13 Hydro bromic acid 41.00 41.00 Indigenous
14 Hyflow 10.00 10.00 Indigenous
15 Iodine 3.00 3.00 Indigenous
16 IPA 4200.00 4200.00 Indigenous
17 Isopropyl ether 240.00 240.00 Indigenous
18 Magnesium turnings 28.00 28.00 Indigenous
19 Methane sulfonyl chloride 50.00 50.00 Indigenous
20 MPR 173.00 173.00 Indigenous
21 Oxalic acid 74.00 74.00 Indigenous
22 Sodium chloride 20.00 20.00 Indigenous
23 Sodium hydroxide 10.00 10.00 Indigenous
24 Sodium sulfate 260.00 260.00 Indigenous
25 Tetrahydrofuran 1000.00 1000.00 Indigenous
27 Triethylamine 15.00 15.00 Indigenous
5. ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

Kgs Kgs
1 Omeprazole sulfide 88.00 146.67 Indigenous
2 Cumin hydro peroxide 41.00 68.33 Indigenous
3 Potassium hydroxide 15.20 25.33 Indigenous
4 DET 11.30 18.83 Indigenous
5 Titanium isopropoxide 2.50 4.17 Indigenous
6 NEDIPA 4.50 7.50 Indigenous
10 Magnesium sulfate 16.00 26.67 Indigenous

6. ETHYL MAGNESIUM CHLORIDE

Kgs Kgs
1 Ethyl Chloride 724.00 362.00 Indigenous
2 Mg turnings 276.00 138.00 Indigenous
7. LINEZOLID

Kgs Kgs
1 N-[3-Phthalimido-2R-
hydroxypropyl-3-fluoro-4- 110.00 81.47 Indigenous
morpholinyl aniline
2 Carbonyl di imidazole 43.25 32.03 Indigenous
3 Hydrazine Hydrate 13.35 9.89 Indigenous
4 Acetic anhydride 27.23 20.17 Indigenous
6 MDC 2682.00 1986.47 Indigenous
8 Ethyl acetate 805.00 596.24 Indigenous
8. LOPERAMIDE HYDROCHLORIDE
Used /Batch Used/ Day in

in Kgs Kgs
1 N-[(2Z)-3-
(diphenylmethyl)dihydrafuran- 122.00 45.18 Indigenous
2(3H)-ylidene]methanamine
2 4-(Chloro phenyl)-Piperidine-
75.00 27.78 Indigenous
4-ol
3 Potassium carbonate 25.00 9.26 Indigenous
4 Potassium Iodide 1.00 0.37 Indigenous
8 Methanolic HCl (10%) 125.00 46.29 Indigenous
9 Activated Carbon 20.00 7.41 Indigenous

9. MAGNESIUM TERTIARY BUTOXIDE

Kgs Kgs
1 Methyl Magnsium Chloride 214.00 535.00 Indigenous
3 Tert-Butanol 200.00 500.00 Indigenous
10. METFORMIN HYDROCHLORIDE

Kgs Kgs
1 Dimethyl amine Hcl 126.00 840.00 Indigenous
2 N-Cyano guanidine 130.00 866.67 Indigenous
3 Xylene 300.00 2000.00 Indigenous
5 Hyflow 1.00 6.67 Indigenous
11. METHYL MAGNESIUM CHLORIDE

Kgs Kgs
1 Magnesium Metal 974.00 216.55 Indigenous
2 Methyl Chloride 2026.00 450.45 Indigenous
12. N, N-DIMETHYL PROPYL MAGNESIUM CHLORIDE

Kgs Kgs
(3-Chloro-propyl)-dimethyl-
1 417.00 556.00 Indigenous
amine
3 EDB 1.00 1.33 Indigenous
4 Iodine 0.20 0.27 Indigenous

13. OMEPRAZOLE

Kgs Kgs
1 3,5-Lutidine 33.00 220.00 Indigenous
2-Mercapto-5-methoxy
Benzimidazole
5 Ammonium hydroxide 22.00 146.67 Indigenous
6 Dimethyl sulphate 38.30 255.33 Indigenous
7 Hydrogen Peroxide 23.00 153.33 Indigenous
9 Nitric acid 19.50 130.00 Indigenous
11 Sodium methoxide 16.40 109.33 Indigenous
12 Stage-1 252.00 1680.00 Indigenous
13 Thionyl Chloride 36.00 240.00 Indigenous

14. PANTOPRAZOLE SODIUM

Kgs Kgs
1 Maltol 66.00 165.00 Indigenous
5-diFluoromethoxy-2-
2 mercapto- 108.00 270.00 Indigenous
benzimidazole
4 Acetic Anhydride 172.00 430.00 Indigenous
7 Ammonia 9.00 22.50 Indigenous
8 Ammonium Carbonate 50.00 125.00 Indigenous
9 Ammonium Chloride 25.00 62.50 Indigenous
11 Chloroform 1050.00 2625.00 Indigenous
12 Dimethyl sulphate 33.00 82.50 Indigenous
13 Hydrogen peroxide 17.00 42.50 Indigenous
16 Methylene dichloride 1300.00 3250.00 Indigenous
17 Phosphorous oxy chloride 26.00 65.00 Indigenous
18 Potassium carbonate 36.00 90.00 Indigenous
20 Sodium Hydroxide flakes 20.00 50.00 Indigenous
21 Sodium hypochlorite 37.00 92.50 Indigenous
22 Sodium methoxide 27.00 67.50 Indigenous
24 Thionyl chloride 60.00 150.00 Indigenous
15. PHENYL MAGNESIUM CHLORIDE

Kgs Kgs
2 Chlorobenzene 820.00 410.00 Indigenous

16. QUETIAPINE FUMARATE
Used /Batch Used/ Day

in Kgs in Kgs
1 2-Aminbiphenylsulphate 140.00 116.67 Indigenous
3 Chloro ethoxy ethanol 59.00 49.17 Indigenous
4 Fumaric acid 85.00 70.83 Indigenous
5 Hydrogen gas 1.02 0.85 Indigenous
6 Methanol. 400.00 333.33 Indigenous
7 Phenyl chloro fumarate 118.50 98.75 Indigenous
8 phosphoric acid 46.70 38.92 Indigenous
9 Piperazine 44.00 36.67 Indigenous
17. RABEPRAZOLE SODIUM
S. Used /Batch Used/ Day in

Raw Material Source
No in Kgs Kgs
1 2,3-Lutidine 46.00 76.67 Indigenous
2 2-Mercaptobenzimidazole 53.00 88.33 Indigenous
3 3-Methoxy-1-Propanol 43.00 71.67 Indigenous
5 Acetic anhydride 39.00 65.00 Indigenous
9 DMSO 200.00 333.33 Indigenous
10 Hydrochloric acid 20.00 33.33 Indigenous
11 Hydrogen Peroxide (50%) 33.00 55.00 Indigenous
12 Isopropyl Alcohol 300.00 500.00 Indigenous
13 MDC 1350.00 2250.00 Indigenous
14 MMA in Methanol 10.00 16.67 Indigenous
15 Nitric acid 38.00 63.33 Indigenous
16 Sodium hydro sulphate 12.00 20.00 Indigenous
18 Sodium Hypochlorite (8%) 327.00 545.00 Indigenous
19 Sodium Sulphate 10.00 16.67 Indigenous
20 Stage-1 515.00 858.33 Indigenous
21 Thionyl Chloride 53.00 88.33 Indigenous

18. SODIUM METHOXIDE

Kgs Kgs
19. SODIUM TERT BUTOXIDE

Kgs Kgs
1 Sodium 141.18 188.24 Indigenous
2 Tert-Butanol 650.00 866.67 Indigenous
20. TELMISARTAN

Kgs Kgs
Methyl-4-methyl-1,1-
biphenyl-2-carboxylate
1,3-dibromo-5,5-dimethyl
6 Azo bis isobutyronitrile 2.90 2.90 Indigenous
7 Chloroform 320.00 320.00 Indigenous
8 Hydrochloric acid 81.00 81.00 Indigenous
11 Methanolic ammonia 50.00 50.00 Indigenous
Methyl-4-(butyramido)-3-
methyl-5-nitrobenzene
13 n-Hexane 100.00 100.00 Indigenous
N-Methylbenzene-1,2-
diamine
Palladium carbon(Wet 5%
MC)
16 Phosphoric acid 90.00 90.00 Indigenous
17 Potassium hydroxide 33.00 33.00 Indigenous
19 Sodium meta bisulphate 4.30 4.30 Indigenous

Annexure - VIII
LIST OF BY -PRODUCTS
Name of the Quantity

S. No Name of the Product
By- Product In Kg/Day
Piperazine
1 Ciprofloxacin Hydrochloride 41.00
Hydrochloride
2 N-Butyl Lithium Lithium Chloride 171.00
3 Ritonovir 4-Nitro phenol 46.00

Annexure - IX
WASTE WATER DETAILS
S. No Purpose Effluent
In KLD
1 Process 52.39
2 Washings 2.00
3 Boiler Blow down 8.50
4 Cooling towers Blow down 26.00
5 DM Plant Regeneration 2.00
6 Scrubbing system 2.00
7 Domestic 2.00
Total 95.00
HTDS & LTDS DETAILS
Unit HTDS LTDS Effluent Treatment Method

KLD KLD Generation
in KLD
Process 29.98 22.41 52.39 HTDS Effluent after
Washings 0.00 2.00 2.00 neutralization, filtration
Boiler Blow down 8.50 0.00 8.50 sent to MEE.
Cooling towers Blow LTDS effluents along with
down 26.00 0.00 26.00 MEE condensate will be
DM Plant sent to Biological
Regeneration 2.00 0.00 2.00 treatment and finally to
RO system
RO Rejects to MEE
system and RO permeate
to reuse; MEE residue to
Scrubbing system 2.00 0.00 2.00 ATFD for drying.
Septic tank followed by
Domestic 0.00 2.00 2.00 soak pit
Total 68.48 26.41 95.00

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LIST OF ENCLOSURES

11 List of By - Products Annexure-VIII

12 Waste water Details Annexure-IX

LIST OF PROPOSED PRODUCTS

CAS Therapeutic Quantity

11 Methyl magnesium chloride 676-58-4 Organic Reagent 20000.00

Prepared By Rightsource Industrial Solutions Pvt. Ltd. Page 1

1. BENZYL MAGNESIUM CHLORIDE

BENZYL MAGNESIUM CHLORIDE

Magnesium Benzyl chloride Benzylmagnesium chloride

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 2

BENZYL MAGNESIUM CHLORIDE

BENZYL MAGNESIUM CHLORIDE

BENZYL MAGNESIUM CHLORIDE

Material Balance of Benzyl Magnesium Chloride

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 3

2. BUTYL MAGNESIUM CHLORIDE

BUTYL MAGNESIUM CHLORIDE

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BUTYL MAGNESIUM CHLORIDE

BUTYL MAGNESIUM CHLORIDE

BUTYL MAGNESIUM CHLORIDE

Material Balance of Butyl Magnesium Chloride

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N-carbethoxy-4-piperidone is reacted with Hydrogen and Ammonia in the presence of

Stage-1 reacts with 2, 5-Dichloro nitrobenzene & Sodium Carbonate in presence of

Stage-4 undergoes hydrolysis with Sodium Hydroxide to give Stage-5 as product.

Stage-5 reacts with 1-(3-chloropropyl)-1, 3-dihydro-2H-benzimedazole-2-one and

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 6

Ammonia 4-Amino-piperidine-1- 18.00

4-Amino-piperidine-1- 2,5-Dichloro Sodium 4-(4-Chloro-2-nitro-phenylamino)

NaCl + 1/2 CO2 1

Sodium chloride Carbon dioxide 1

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 7

4-(4-Chloro-2-nitro-phenylamino) Hydrogen 4-(2-Amino-4-chloro-phenylamino)

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4-(5-Chloro-2-oxo-2,3-dihydro-benzoimidazol Sodium hydroxide 5-Chloro-1-piperidin-4-yl-1,3

Sodium ethoxide Carbon dioxide

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 9

Sodium chloride Water Carbon dioxide

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Material Balance of Domperidone

Material Balance of Domperidone

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 12

Material Balance of Domperidone

Material Balance of Domperidone

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 13

Material Balance of Domperidone

Material Balance of Domperidone

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5-Bromo phthalide reacts with P-Fluoro Magnesium chloride in the presence of

Stage-3 undergoes resolution in the presence of Toluene as a solvent media to give

Stage-4 undergoes cyclisation in the presence of Toluene as a solvent media to give

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 15

5-Bromo pthalide P-Fluoromagnesium Dimethyl amino 3X18=54.00

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4-Dimethylamino-1-(4-fluoro- Hydrobromic acid 4-Dimethylamino-1-(4-fluoro-

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{3-[5-Bromo-1-(4-fluoro-phenyl)-1,3-dihydro-isobenzofuran- Oxalic acid

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 19