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 Simeticone
Applications
- 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
Product Details
| Property | Average Result |
|---|---|
| Viscosity | 1,400 cP (1,400 mPa*s) |
| Simethicone Content | 100 % |
| Defoaming Test | 3 seconds |
| Loss On Heating | 0.25 % |
| Appearance | Translucent Gray |
| Heavy Metals | 5 ppm |
| Comment | Simethicone USP/EP |
The Strongest Silicone Elastomer Ever Developed
Dr. Jim Lambert, NuSil® Director of Research and Development, Biomaterials, introduces our breakthrough material that has a tensile strength of up to 50% greater than existing silicone elastomers on the market.
The test data shown for this material is the average value for typical properties. All of these properties may not be tested on a lot to lot basis and cannot be used to draft specifications. Please contact NuSil for assistance and recommendations in establishing limits for product specifications.