MED-340

SIMETHICONE USP/EP

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

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

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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.