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simethicones lifesciences generalhealthcare

MED-346

SIMETHICONE 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/Halal Certified
  • Chemically inert, therefore does not alter the characteristics
  • of material to be defoamed
  • Outstanding behavior in alkaline systems
  • Easy to disperse in most aqueous and anhydrous foaming
  • systems
  • Effective in low doses such as 1 to 100 mg per kg of material
  • to be defoamed
  • Produced in a registered drug facility according to criteria set
  • by the U.S. Food and Drug Administration
  • 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 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
  • Highly effective for control of foam in aqueous and anhydrous systems
  • For use in treatments for stomach pain
  • For use in antacid gels
  • For use in treatments for ulcers and gas due to abnormal swallowing

(1) Current edition of the European Pharmacopeia


Product Details

Property Average result
Viscosity 1,325 cP
Simethicone Content 100 %
Defoaming Test 3 seconds
Loss On Heating 0.2 %
Appearance White gray
Heavy Metals 5 ppm
Comment Simethicone EP
Display in metric units
 

The above properties are tested on a lot-to-lot basis. Do not use as a basis for preparing specifications. Please contact NuSil Technology for assistance and recommendations in establishing particular specifications.

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