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MED-340

Simethicones

Simethicone

DESCRIPTION

Designated by the FDA-OTC Antacid and Antiflatulent Review Panel as a safe and effective antiflatulent component of antacid and other gastrointestinal preparations
Kosher and Halal certified
Outstanding pharmaceutical versatility
Excellent properties including low volatility and resistance to silica separation
One of the fastest defoamers of any Simethicone made
Produced in a registered drug facility according to criteria set by the U.S. Food and Drug Administration
Demonstrates bubble-coalescing activity and lubricity
Produced in a facility compliant with Good Manufacturing Practices (FDA regulations 21 CFR Part 210 & 211 and ICH Q7)
Tested in accordance with and meets all the requirements of the United States Pharmacopeia (USP) for Simethicone and the European Pharmacopeia (EP) for Simeticone1

APPLICATION

Cited in FDA regulations 21 CFR 332.10 and 21 CFR 332.15 as a safe and effective over-the-counter drug to alleviate the symptoms of gas associated with heartburn, sour stomach, acid indigestion and post operative gas pain
Cited in FDA regulation 21 CFR 173.340 as being safe to use in food processing applications (refer to FDA regulation for allowable levels in specific food processing applications)
Provides lubrication for uniform and bubble-free application of topical preparations such as antibiotic ointments and contraceptive gels
Effective in acne and other dermatological ointments, creams and lotions due to its lubricity and anti-whitening properties
As an antifoam in the manufacture and separation of drug products made by microbial fermentation
For use in enzyme digestive aids and as a stabilizer in making belladonna extract and in cod liver oil extraction
Useful in packaging aqueous solutions such as prepared douches where foaming can impede operations
Listed in the International Cosmetic Ingredient Dictionary as a material useful for the formulation of cosmetic and toiletry products
Valuable for packaging and filling operations for such products as liquid soaps, shampoos and hair conditioners
For a soft, silky feel in many hand creams and lotions, as it provides better cost efficiency and performance than dimethicone

PROPERTIES
Typical Properties	Average Result
Appearance	Translucent gray, viscous fluid
Viscosity	1,400 cP (1,400 mPas)
Simethicone, USP/EP Content	100%
Defoaming Test	3 seconds
Loss on Heating	0.25%
Heavy Metals (as Lead)	5 ppm maximum
Mineral Oils	Pass

Properties tested on a lot-to-lot basis. Do not use the properties shown in this technical profile as a basis for preparing specifications. Please contact NuSil Technology for assistance and recommendations in establishing particular specifications.

Packaging

5 Gallon Pail (18.0 kg)
Drum (200 kg)
Tote (1000 kg)

Shelf Life

36 months