VERITAS PHARMACEUTICALS LIMITED,

' #*ritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

STANDARD TEST PROCEDURE

Name COLLOIDAL SILICON DIOXIDE USP

Document No.: TP/'l '103001/01 lssue Date : 24Jan2014

Version No.:01 Superseded doc. No,: VRME/C/06'l 2/002 Review Date : 23 Jan2017

Aoproval of Current Version of the Document

Name Job Title Sionature & Date

Prepared by Md. Monjur Rahman Quality Control Officer

%Ytzr*
Agreed by Md. Tarikul lslam Bossunia Asst. Manager Quality Control '0qffiofl^
Approved by Md. Moniruzzaman Quality Assurance Manager M%,el'lY

CONTENT

1. Description
2. Solubility
3. ldentification
4. Assay (ignited basis)
5 Loss on ignition,
6. Arsenic
7. pH
8. Loss on drying
9. Revision History

DISTRIBUTION LIST

QC Laboratory 01

This document is Effective from the Date of the Approval.

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER DELEGATE, COPY OF THIS
DOCUMENT IS STRICTLY PROHIBITED

IF THE DOCUMENT IS SIGNED BY BLUE IN& IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTTNE WORK
Page 1 of 3
 VERITAS PHARMACEUTIGALS LIMITED,
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas
STANDARD TEST PROCEDURE

MaterialName: COLLOIDAL SILICON DIOXIDE USP

Doc. No.: TP/1 103001/01 Version:01 Prepared By: Approved ay:

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1. Description
Procedure:

Take about 1 gm of sample in a watch glass and observe for its physical appearance, color, etc. using a white background.

Limit: Light white non gritty powder of exkemely fine particle size (about 15 pm).
Solubility
Procedure:
Descriptive term Approximate volume of Solvent in millilitres per gram of solute
Very soluble Less than 1

Freely soluble From 1 to 10

Soluble From 10 to 30

Sparingly soluble From 30 to 100

Slightly soluble From 100 to 1 000

Very slightly soluble From 1 000 to 10 000

Practically insoluble More than 10 000

Limit: lnsoluble in water and in acid (except hydrofluoric acid); soluble in hot solution of alkali hydroxides.
ldentification
A: Transfer about 5 mg to a platinum crucible, and mix with about 200 mg of anhydrous potassium carbonate. lgnite at a
red

heat over a burner for about 10 minutes, and cool. Dissolve the melt in 2 mL of freshly distilled water, warming if necessary,

and slowly add 2 mL of ammonium molybdate TS to the solution: a deep yellow color is produced"

B: place 1 drop of the yellow silicomolybdate solution obtained in ldentification test A on a filter paper, and evaporate the
blue,
solvent. Add 1 drop of aiaturated solution of o{olidine in glacialacetic acid to reduce the silicomolybdate to molybdenum
and place the paper over ammonium hydroxide: a greenish blue spot is produced.

4. Assay
Transfer about 500 mg of Colloidal Silicon Dioxide to a tared platinum crucible, ignite at 1000 r25 'for 2 hours, cool in a
desiccator, and weigh.ldd 3 drops of sulfuric acid, and add enough alcoholto just moisten the sample completely. Add 15 mL
of hydrofluoric acid, and in a weil-ventilated hood evaporate on a hot plate to dryness, using medium heat (95 to 105 ) and
taking care that the sample does not spatter as dryness is approached. Heat the crucible to a red color with the aid of a Bunsen
burnir. lgnite the residue at 1000 t25
for 30 minutes, cool in a desiccator, and weigh. lf a residue remains, repeat the
procedure, beginning with "add 15 mL of hydrofluoric acid." The weight lost by the assay specimen, previously ignited at 1000
I 25 , represents the weight of Si02 in the portion taken..

Limit: 99.0 -'100.5% (ignited basis)

Loss on Ignition (zge)

Dry a weighing crucible in an muffle furnace at 1000'C for 30 minutes. Place it in desiccators, allow cooling and weighing.
Accurately weigh about 1.0 g of dried sample in the crucible and ignite it in the furnace. .Remove the crucible and allow cooling
in desiccators and reweigh. Calculate the percentage of loss on ignition using the following formula:
Galculation:
(W1-W2)x100
(w1-c)
Where, C = Weight of the crucible (in g)
W1 = Weight of the crucible and sample before ignition (in g).
W2 = Weight of the crucible and the sample after ignition (in g).

Limit: NMT 2.0%

IF THE DOCUMENT IS SIGNED BY BLUE IN& IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
Page 2 of 3
 VERITAS PHARMACEUTICALS LIMITED,
ffieritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

STANDARD TEST PROCEDURE

MaterialName: COLLOIDAL SILICON DIOXIDE USP

Doc. No.: TP/1 103001/01 Version:01 Prepared rr,

}37ffiYo
Approved ay: -ffi],1'l

6. Arsenic (211)

Prepare the Test Preparation as follows. Transfer 2.5 g to a flask, add 50 mL of 3 N hydrochloric acid, and reflux for 30 minutes
using a water condenser. Cool, filter with the aid of suction, and hansfer the filtrate to a 100-mL volumetric flask. Wash the filter
and flask with several portions of hot water, and add the washings to the flask. Cool, dilute with water to volume, and mix: a
15.0-mL portion of this solution, to which 3 mL of hydrochloric acid has been added, meets the requirements of the test, the
addition of the 7 N sulfuric acid being omitted. The limit is 8 pg per g.

Limit: NMT 8.0 ppm

7. pH (zst)

Disperse 1 g in 25 mlwater

Limit:3.5 - 5.5

8. Loss on Drying (zet)

Dry a crucible in an oven at 1050C for 30 minutes. Place it in desiccators, allow cooling and weighing. Accurately weigh about

1.0 g of sample in the crucible and dry in an oven at 100-105oC.Remove the crucible from oven and allow cooling in

desiccators and reweigh. Calculate the percentage of loss on drying using the following formula:

Calculation:

(W1-W2)x100

(w1_c)

Where, C = Weight of the weighing bottle (in g)

W1 = Weight of the weighing bottte and sampte before drying (in g).

W2 = Weight of the weighing botile and the sample after drying (in g).

Limit: NMT 2.5 %

9. Revision History

Document,Nd. Version No Date Reason

vRME/C/o612/002 00 Jan2012 lnitial procedure for analysis of Colloidal Silicon Dioxide

TP/1 103001/01 01 Jan2014 To detail the procedure for analysis of Colloidal Silicon

IF THE DOCUMENT IS SIGNED BY BLUE INIC IT IS A MASTER DOCUMENT AND CAN NOT
BE USED FOR ROUTINE WORK
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