EMP 030730e - Soluble Kollidon Grades

Pharma
Ingredients
& Services
= Registered trademark of BASF SE Soluble polyvinylpyrrolidone for the pharmaceutical industry
Soluble Kollidon
grades
Povidone Ph.Eur., USP, JP
Technical Information
August 2008
Supersedes issue dated June 2007
EMP 030730e-05/Page 1 of 12
Contents
Page
1. Introduction 3
1.1 General 3
1.2 Synonyms 3
1.3 Product range 3
2. Specications and stability 4
2.1 Specications 4
2.2 Regulatory status 4
2.3 Microbial status, absence of pyrogens 4
2.4 Residual solvents 4
3. Physical and chemical properties 4
3.1 Description 4
3.2 Molecular weight 4
3.3 Viscosity 5
3.4 Solubility 5
3.5 Hygroscopicity 6
3.6 Particle-size distribution 6
3.7 Bulk density 6
3.8 Stability in solutions, sterilization 6
3.9 Complexation, chemical interactions 7
4. Applications 7
4.1 General 7
4.2 Binder for tablets 7
4.3 Solubilization 9
4.4 Co-precipitation, co-milling 9
4.5 Stabilizer for suspensions 9
4.6 Thickening agent 9
4.7 Ophthalmics 10
4.8 Sugar-coating 10
4.9 Film-coating 10
4.10 Miscellaneous applications 10
4.11 Food products 10
5. Toxicological data 11
6. PBG- and PRD-No. 12
7. Packaging 12
8. Stability and storage 12
9. Safety Data Sheets 12
10. Note 12
EMP 030730e-05 August 2008 Page 2 of 12 Soluble Kollidon grades
1. Introduction
1.1 General The foundations of modern acetylene chemistry were laid by Reppe at BASF. One
of the many products to emerge from this work was soluble polyvinylpyrrolidone,
which is obtained by radical polymerization of N-vinylpyrrolidone

Monomer unit: 111.14

Because of its sol u bil ity in water and in many organic sol vents, its high bind ing
power and abil ity to form com plexes, sol u ble poly vi nyl pyr rol i done occu pies a
spe cial posi tion among the syn thetic col loids.

Sep ar ate Tech ni cal Data Sheets are avail able for the insol u ble Kol li don grades
(cros pov i done) and for Kollidon VA 64, a copol ymer of N-vinyl pyr rol i done and
vinyl ace tate (copo vi done).

More infor ma tion on Kollidon-Grades may be found in the book, Kollidon, Poly vi nyl-
pyr rol i done for the Phar ma ceu ti cal Indus try. This information is available on CD-
ROM, too.
1.2 Syno nyms Sol u ble poly vi nyl pyr rol i done is also known as pov i don(e), povid o num, poly vi done,
poly(1-vinyl-2-pyr rol i done) and PVP.
1.3 Product range As the require ments dif fer con sid er ably in the var i ous elds of appli ca tion, it has
been found nec es sary to create two prod uct lines: the Kollidon grades for phar ma-
ceu ti cal prod ucts and the Luvis kol
grades for cos met ics and tech ni cal appli ca tions.

The Kollidon range con sists of the fol low ing prod ucts:

- Kollidon 12 PF
- Kollidon 17 PF
- Kollidon 25
- Kollidon 30 Origin Germany
- Kollidon 90 F

2. Specications and stability
2.1 Specications See separate document: Standard Specication (not for regulatory purposes)
available via BASFs WorldAccount: https://worldaccount.basf.com (registered
access).
2.2 Regulatory status Kollidon 12 PF meets current Ph.Eur. and USP/NF povidone monograps.
Kollidon 17 PF, Kollidon 25, Kollidon 30 Origin Germany, Kollidon 90 F meet
current Ph.Eur., USP/NF and JP/JPE povidone monographs.

2.3 Microbial status, endotoxins The microbial status is determined by Ph.Eur. 5 methods 2.6.12 and 2.6.13.
The limits given in the European Pharmacopoeia (Table 1) apply to all the soluble
Kollidon grades.
Table 1 Microbial purity requirements
(Ph.Eur. 5, 5.1.4, Categories 2 + 3A)
Max. 10
2
aerobic bacteria and fungi/g
No Escherichia coli/g
Max. 10 Enterobacteriaceae and other gram-negative bacteria/g
No Pseudomonas aeruginosa/g
No Staphylococcus aureus/g
Kollidon 12 PF and Kollidon 17 PF are tested for bacterial endotoxins by Method
2.6.14 in the 5th edition of the European Pharmacopoeia. A 6% solution of Kollidon
in isotonic sodium chloride solution is tested.
2.4 Residual solvents The Kollidon grades fulll the requirements for residual solvents (Class 3, Ph.Eur.
5, 5.4)
3. Physical and chemical properties
3.1 Descrip tion All grades of Kollidon are sup plied in the form of an almost white free-ow ing
pow der. They have a slight char ac ter is tic odour.
3.2 Molec u lar weight With poly mers gen er ally, the aver age molec u lar weight can be expressed in
three forms: weight, number and vis cos ity aver age.
The molec u lar weight of pov i done is usu ally expressed as the K-value, from
which it is pos sible to cal cu late the vis cos ity aver age molec u lar weight (M
v
).
How ever, the weight aver age molec u lar weight (M
w
) is found more fre quently in
the lit er a ture. It is deter mined by meth ods such as light scat ter ing that meas ure
the weight of the mole cules.
The fol low ing M
w
val ues were deter mined for dif fer ent grades of Kollidon in
recent meas ure ments.
Kollidon 12 PF 2 000 3 000
Kollidon 17 PF 7 000 11 000
Kollidon 25 28 000 34 000
Kollidon 30 Origin Germany 44 000 54 000
Kollidon 90 F 1 000 000 1 500 000

Earlier measurements of M
w
that were not quite so accurate gave values of 40,000
for Kollidon 30 and 700,000 for Kollidon 90, for example.
3.3 Viscosity Fig. 2 shows the relationship between the viscosity of aqueous solutions of the
different grades of Kollidon and their concentration.

Fig. 2 Viscosity of Kollidon solutions (Ubbelohde viscometer, 25C)
3.4 Sol u bil ity The sol u bil ity of Kollidon var ies con sid er ably from one sol vent to another. In Table 2
below, sol u ble sig ni es that a solu tion of at least 10% can be pre pared, and
insol u ble sig ni es that the sol u bil ity is less than 1%.
Table 2 Sol u bil ity of Kollidon Grades
Sol u ble in:
chlo ro form n-buta nol
cyclo hex a nol n-prop a nol
eth a nol abs. poly eth y lene gly col 400
glyce rine (= Lutrol
E 400)
iso prop a nol pro py lene gly col
meth a nol tri eth a nol a mine
meth yl ene chlo ride water
Insol u ble in:
cyclo hex ane pen tane
die thyl ether car bon tet ra chlo ride
ethyl ace tate toluene
liq uid par af n xylene

3.5 Hygro sco pic ity The hygro scopic nature of Kollidon is impor tant in many appli ca tions. There is
hardly any dif fer ence between the indi vid ual grades so that the same curve applies
to all (Fig. 1).

Fig. 1 Hygro sco pic ity of sol u ble Kollidon
3.6 Particle-size distribution In the pharmaceutical technology of solid dosage forms, particularly in the direct
compression of tablets, the particle-size distribution of the solid ingredients used
is a factor of some signicance.
The following table gives some typical particle-size distribution values (determined
in an air-jet sieve; 5 min, 20 mbar):
Table 3 Particle-size distribution, %
< 50 > 250
Kollidon 25/30 approx. 10 max. 5
Kollidon 90 F max. 10 max. 20

3.7 Bulk density The bulk density of Kollidon is determined according to Ph.Eur. 5, Section 2.9.16.
Table 4 Bulk density of the Kollidon grades
Kollidon 12 PF 400-600 g/l
Kollidon 17 PF 400-600 g/l
Kollidon 25/30 400-600 g/l
Kollidon 90 F 400-550 g/l

3.8 Stabil ity in solu tion, Particle size distribution and bulk density are considered characteristic values.
ster il iza tion They are not part of any specications. Aqueous solu tions of pov i done have no
buf fer ing action. If left to stand, and par tic u larly if heated, they take on a slight
yel low ish colour. The yel low ing can be dimin ished by add ing a reduc ing agent,
e. g. sodium met a bis ul te or cys tein. Local leg is la tion on the use of sodium met-
a bis ul te in paren ter als must be observed.
For ster il iza tion pur poses, 0.01-0.1% sodium met a bis ul te or 0.05-0.1% cys tein,
as a pro por tion of the Kollidon, is added to the solu tion which is then heated in
the absence of air.
3.9 Com plex a tion,
chem i cal inter ac tions
Po vi done can form fairly stable asso ci a tion com pounds or com plexes with a
num ber of active sub stances. The best known exam ple is PVP- iodine which is
the sub ject of a sep ar ate leaet.

The abil ity of Kollidon to form a water-sol u ble com plex with insol u ble active sub-
stances can be used in phar ma ceu ti cals to improve the release rate and sol u bil ity
of drugs (see Sec tions 4.3 and 4.4).

There are a few sub stances such as the poly phen ols that form stronger com plexes
that can pre cip i tate in neu tral or acidic media. This effect can be used in the removal
of poly phen ols and anthoc ya no gens from solu tions or bev er ages. How ever, insol u ble
poly vi nyl pyr rol i done (Kollidon CL) is most suit able for this pur pose.

It must be noted that if pov i done is com bined with strongly alka line sub stances
such as lith ium car bo nate or sodium hydrox ide it can cross link and become insol u ble,
par tic u larly at ele vated tem per a tures. In extreme cases, this can increase the vis-
cos ity of liq uid pres en ta tion forms and delay bio avail abil ity in solid pres en ta tion
forms.
4. Applications
4.1 General The main applications of the soluble Kollidon grades are summarised in Table 5.
Table 5: Main applications of the soluble Kollidon grades
Binder
Tablets, capsules, granules
Bioavailability enhancement
Tablets, capsules, granules, pellets,
suppositories, transdermal systems
Film formation
Opthalmic solutions, tablets, medical plastics
Solubilization
Oral, parenteral and topical solutions
Taste masking
Oral solutions
Lyophilising agent
Injection preparations, oral lyophilisates
Stabilisation of suspensions
Oral and parenteral suspensions, instant
beverage powders and granules
Hydrophylization
Medical plastics, retard preparations,
suspensions
Adhesives
Transdermal systems, adhesive gels
Drug stabilisation
Enzymes in diagnostics
Toxicity reduction
Injection preparations

The adhe sive, lm-form ing, dis pers ing and thick en ing prop er ties of the sol u ble
Kollidon grades are used in tab let pro duc tion, sugar coat ing, lm coat ing and in
the prep ar a tion of other dos age forms. The improve ment in the sol u bil ity of active
ingre dients brought about by com plex a tion or asso ci a tion, and the thick en ing
effect nd use mainly in the man u fac ture of liq uid pres en ta tion forms.
The grade of Kollidon that is selected depends mainly on its molec u lar weight, as
this dic tates the vis cos ity, bind ing effect, the com plex a tion capac ity and how read ily
it is elim i nated from the body.
A detailed descrip tion of the appli ca tions is to be found in the book, Kollidon,
poly vi nyl pyr rol i done for the Phar ma ceu ti cal Indus try.
4.2 Bind er of tab lets Kollidon 25, 30 and 90 F
Kollidon 25, 30 and 90 F give hard, free-ow ing gran ules for tab let mak ing with
a low pro por tion of nes and high bind ing strength. For Kollidon 25 and 30, the
quan tity required lies between 2% and 5% of the tab let weight. For Kollidon 90 F,
less than 2% is gen er ally required, because of its great bind ing capac ity. The high
vis cos ity of binder solu tions made with Kollidon 90 F some times requires cer tain
pre cau tions to ensure that the gran ules are evenly wet ted. Gran u la tors or spray ing
machines that have a strong mix ing action are help ful.
The addi tion of poly eth y lene gly col 400 ( Lutrol E 400) as a plas ti cizer or the
replace ment of the pov i done with Kollidon VA 64 is often help ful if the gran ules
are too brit tle.
Kollidon 25, 30 and 90 F are also suit able for the direct com pres sion of tab lets
with out gran u la tion (prior to 1993, Kollidon 90 was unsuit able for this pur pose
because of its par ti cle size). This tech nique requires a cer tain rel a tive humid ity,
as the pow der mix ture must have a cer tain mois ture con tent to bind prop erly.
If Kollidon is used in addi tion to micro crys tal line cel lu lose, it not only makes the
tab lets harder but also gives them stronger edges. For best results in direct
com pres sion, all the exci pients should have a cer tain mois ture con tent. This
applies to starch, micro crys tal line cel lu lose and lac tose mono hy drate as ll ers.
It can be seen from Fig. 3 that there is hardly any difference in the hardness of
lactose placebo tablets made with Kollidon 25 and Kollidon 30. However, the
same quantity (3% of the tablet weight) of Kollidon 90 F almost doubles the
hardness, compared with Kollidon 25.

Fig. 3 Lactose monohydrate tablets with 3% Kollidon (wet granulation)
Kollidon is also suitable as a binder for modern processes such as uid ized-bed
granulation. Thanks to their relatively low viscosity, solutions of Kollidon 25 and
Kollidon

30 can be prepared relatively quickly, and sprayed easily, to quickly
give hard dust-free uniform granules. If the spray includes pigments, Kollidon
improves their distribution.
A typical formulation for wet granulation with Kollidon 30 is given below in Table 6
for alpha-methyldopa tablets. The formulation was tried out on a laboratory scale.
Table 6 Alpha-methyldopa tablets and cores (275 mg)
I Alpha-methyldopa 275 g
Lactose monohydrate 55 g
II Kollidon 30 15 g
Isopropanol 80 ml
III Kollidon CL 8 g
Magnesium stearate 2 g
Granulate mixture I with solution II, dry, sieve, mix with the ingredients in III and
compress into tablets on a rotary tablet press with medium force (approx. 15 kN).
The tablets produced in the laboratory had the following properties:
Weight (measured) 361 mg
Diameter: 12 mm
Hardness: 118 N
Disintegration time (gastric juice): 5 min
Friability: 0%
Dissolution acc. to USP in
0.1 N hydrochloric acid:

15 min: 77%
30 min: 98%
4.3 Solubilization Some examples are given as in Table 7 of typical drugs that can be solubilized with
soluble Kollidon.
Table 7 Some of the active ingredients that can be solubilized with
soluble Kollidon
Acetaminophen (paracetamol) Oxytetracycline
Allopurinol Reserpine
Amoxicillin Rifampicin
Chloramphenicol Sulfadimethoxine
Clonazepam Sulfamethazine
Coumarin Sulfamoxole
Diclofenac-Na Sulfathiazole
Doxycycline Tranilast
Furaltadone Trimethoprim
Hydroumethiazide Nitrofural Tyrothricin

Kollidon 12 PF, 17 PF
The low-molec u lar grades, Kollidon 12 PF and Kollidon 17 PF are intended for
use as sol u bi liz ing agents, dis per sants and crys tal liza tion inhib i tors par tic u larly
for inject ables.
These prop er ties are of par tic u lar inter est for anti bi o tics in solu tion or lyo phy li sate
form.
Kollidon 25, 30
In the same way as Kollidon 12 PF and Kollidon 17 PF are used in inject ables,
Kollidon 25 and 30 can be used in prep ar a tions for oral or exter nal appli ca tion as
sol u bi liz ers for the same active ingre dients. One typ i cal exam ple is the for mu la tion
for a par a cet a mol syrup, in which Kollidon 25 increases the sol u bil ity of the active
sub stance and also reduces its bit ter taste.
4.4 Co-precipitation, co-milling Kollidon 25, 30
The dissolution rate and therefore the absorption rate of drugs that do not dissolve
readily in water can be greatly improved by comilling or coprecipitation with Kollidon
25 or Kollidon 30, as the complex formed is, in effect, a solid solution of the drug
in the Kollidon. This requires an excess of Kollidon to maintain the (partially) amorphous
form of the active substance. Suitable processes include mixing, comilling or melt
extrusion of the Kollidon-drug mixture, or coprecipitation, granulation onto a carrier,
or spray-drying a solution containing the drug and Kollidon.
The literature contains hundreds of publications on this application. The most
frequently tested active substance mentioned is probably nifedipine.
4.5 Stabilizer of suspension Kollidon 25, 30, 90 F
Kollidon 25, 30 and 90 F can be used to stabilize oral and topical suspensions with
a wide range of active ingredients, e. g. acyclovir, ibuprofen, magaldrate, nystatin,
phenytoin, trimethoprim, sulfonamides and antibiotics, as well as sugar-coating
suspensions. Combinations of Kollidon 90 F with Kollidon CL-M have often given
very good results.
Kollidon 12 PF, Kollidon 17 PF
The low-molecular endotoxin-free grades of Kollidon can be used to stabilize
parenteral suspensions. This applies particularly to antibiotic.
4.6 Thick ener Kollidon 90 F
Because of its good sol u bil ity in water and alco hol, Kollidon 90 F can be used as
a thick ener for aque ous-alco holic solu tions for oral appli ca tion (vis cos ity curve,
see Sec tion 3.4).
4.7 Use in oph thal mic prep ar a tions Kollidon 17 PF, 25, 30, 90 F
Sol u ble Kollidon can also be used in eye prep ar a tions, because of its sol u bi liz ing,
lm-form ing and thick en ing prop er ties, for instance to ensure that the prep ar a tion
remains in the eye for a cer tain time, to lubri cate the eye, or to sol u bi lize an active
ingre di ent. This appli ca tion requires between 2% and 10% Kollidon. It is added
to some eye drops e. g. with pil o car pine, to pro long the ther a peu tic effect. The
bio avail abil ity of many active sub stances in oph thal mic prep ar a tions can also be
improved or con trolled by add ing Kollidon.
Kollidon is also used in con tact-lens clean ing uids.
4.8 Sugar coat ing Kollidon 25, 30
The good lm-form ing prop er ties, great adhe sive strength and very good dis pers ing
action of Kollidon are very use ful in both tra di tional and auto matic sugar-coat ing
pro cesses. Kollidon 25 and 30 can be added to sugar-coat ing sus pen sions to
pre vent craz ing of the sugar coat ing, and it also ensures that any pig ments in the
coat ing are evenly dis trib uted and that the sus pen sion remains stable. The sugar
coat ing often devel ops craz ing if the tab lets are dried very quickly, result ing in a
mois ture gra di ent between the out side and the inside of the tab let, which can also
hap pen if the sus pen sion con tains large quan tities of pig ment. Kollidon pre vents
the pig ment par ti cles from aggre gat ing again and pro motes the homo ge ne ity of
the sugar layer. Kollidon can also be used to pre vent the migra tion of sol u ble dyes.
4.9 Film coat ings Kollidon 25 and Kollidon 30 are also very use ful in lm coat ing. They are used
as lm-form ing agents, adhe sion pro mot ers and pig ment dis per sers; they also
improve the sol u bil ity of the coat ing in water.
How ever, it must be noted that sol u ble Kollidon can never be used as the sole
lm-form ing agent as it is very hygro scopic and the coat ings it gives are too tacky.
Kollidon can be com bined with all the usual lm-form ing agents such as cel lu lose
deriv a tives or methac ry lates. Alco holic pig ment sus pen sions can be pre pared with
a mix ture of shel lac and sol u ble Kollidon, and these give homo ge ne ous coat ings
par tic u larly in mod ern spray-coat ing and uid ized-bed machines. The addi tion of
Kollidon 25 or Kollidon 30 improves the rate of dis in te gra tion in aque ous solu tion,
as the lm-form ing agents usu ally used have poor sol u bil ity in water. In most cases,
it is rec om mended to strongly dilute the sus pen sion for spray ing.
10% solu tions of Kollidon 25 or Kollidon 30 in eth a nol or iso prop a nol can be used
for sub coat ing mois ture-sen si tive tab let cores.
4.10 Miscellaneous applications Apart from the applications described above, the soluble grades of Kollidon can
be used for the following purposes:
adhesives in adhesive gels, e. g. for dentures
stabilization of nitroglycerin in transdermal systems
in controlled release preparations and transdermal systems to regulate the
release of active substances
hydrophilization and pore formation in plastics for medical applications, e. g.
hollow bres
reduction of the toxicity of certain active substances
cryoprotection, lyophilisation
enzyme stabilization, e. g. in diagnostics
vitamin stabilization
4.11 Food products In 1995, soluble polyvinylpyrrolidone (povidone) with k-values of 25 and higher was
assigned Europe number E 1201 for use in dietetic tablets, e. g. vitamin and dietary
bre tablets, and in sweeteners.
5. Toxicological data Soluble polyvinylpyrrolidone has been used for decades in all kinds of pharmaceutical
preparations, and there are many publications on its good tolerance. In 1987, its
ADI value was set at 050 mg/kg body weight by the World Health Organization
(WHO).
From this literature and the toxicity studies listed below, which were conducted
with different grades of Kollidon, there emerges the following prole of action:
The tolerance of soluble Kollidon after oral absorption is very good on the acute
time scale and after long-term administration. It is neither teratogenic, mutagenic
nor carcinogenic.
It has good skin and mucous membrane tolerance.
The low-molecular grades are quickly eliminated from the system and have been
used for parenteral formulations.
The following toxicological and biochemical studies have been carried out with
the individual soluble grades of Kollidon.
Kollidon 12 PF:
Acute toxicity, mouse i. v.: LD
50
> 11 g/kg
4-week toxicity, rat i. v.
Prenatal toxicity, rabbit i. v.
Excretion of C
14
-labelled Kollidon 12 by female rats after intravenous
administration
Renal elimination of C
14
-labelled Kollidon 12 after intravenous administration
Kollidon 17 PF:
50
> 15 g/kg
Acute toxicity, rat oral: LD
50
> 10 g/kg
Excretion of C
14
-labelled Kollidon 17 by female rats after intravenous
administration
Renal elimination of C
14
-labelled Kollidon 17 after intravenous administration
Mucous membrane tolerance in rabbits eye
Kollidon 25:
50
> 15 g/kg
50
> 10 g/kg
2-year toxicity, rat oral
Prenatal toxicity, rat oral
Kollidon 30
50
> 15 g/kg
50
> 10 g/kg
Test for mutagenic effect of single intraperitoneal application in male mice
Cytogenetic studies in Chinese hamsters after two intraperitoneal applications
Kollidon 90
50
> 8.25 g/kg
4-week toxicity, rat oral
4-week toxicity, dog oral
Prenatal toxicity, rat oral
2-year toxicity, rat oral
We will be glad to provide you with abridged reports of all tests carried out by our
toxicology department or copies of the original reports. They will be available to
you after signing a condentiality agreement.
BASF SE - Care Chemicals Division - Pharma Ingredients & Services - 67117 Limburgerhof - www.pharma-ingredients.basf.com
6. PBG- and PRD-No.
Product PBG-No. PRD-No.
Kollidon 12 PF 10011265 30034972
Kollidon 17 PF 10010750 30034981
Kollidon 25 10000996 30034967
Kolildon 30
Origin Germany
10066831 30034974
Kollidon 90 F 10096088 30034978
7. Packaging Kollidon 12 PF and Kollidon 17 PF: 50-kg PE drum with PE inliner.

Kollidon 90 F: 25-kg carton with welded PE/aluminium inliner.

Kollidon 25 and Kollidon 30: 25-kg carton with welded PE/aluminium inliner.
8. Stability and storage The soluble Kollidon grades retain the properties given in the specica tions over a
period of more than three years, if they are stored in un opened original containers
at room temperature (20-25C). As the K value of Kollidon 90 F gradually declines
under these conditions, this material can only be guaranteed for 24 months.

If Kollidon 90 F is kept refrigerated, its K value decreases more slowly.

Kollidon must be stored tightly closed and protected from light at max. 25C.
9. Safety Data Sheets Safety Data Sheets for the individual grades of Kollidon are available on request.
10. Note This document, or any answers or information provided herein by BASF, does not
constitute a legally binding obligation of BASF. While the descriptions, designs, data
and information contained herein are presented in good faith and believed to be
accurate, it is provided for your guidance only. Because many factors may affect
processing or application/use, we recommend that you make tests to determine
the suitability of a product for your particular purpose prior to use. It does not relieve
our customers from the obligation to perform a full inspection of the products upon
delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED
OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS,
DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE
INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE
DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED
A PART OF OUR TERMS AND CONDITIONS OF SALE.

August 2008

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