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Life Science

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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 PropertiesAverage Result
AppearanceTranslucent gray, viscous fluid
Viscosity1,400 cP (1,400 mPas)
Simethicone, USP/EP Content100%
Defoaming Test3 seconds
Loss on Heating0.25%
Heavy Metals (as Lead)5 ppm maximum
Mineral OilsPass

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

Product Profile - Full Details Product Profile
Material Safety Data Sheet EU EN Material Safety Data Sheet
Example packaging
Example packaging

Biomaterials

Medical Silicones
Biomaterials - Medical Silicones for Healthcare

Advanced Technologies

Advanced Technologies Industrial & Engineering Silicones
Space - Aviation Grade Industrial & Engineering Silicones

Tubing

Food Medical Industrial Grade Silicone Tubing
Food, Medical & Industrial Quality Silicone Tubing

Equipment

Silicone Mixing Dispensing Degassing Equipment
Mixing Dispensing & Degassing Equipment for Silicone