Simethicone USP
Medical & Pharmaceutical Grade Silicone Antifoam
Introduction:
LK-Simethicone USP (United States Pharmacopeia) is a pharmaceutical-grade, low-volatile silicone antifoam compound designed specifically for applications requiring efficient foam suppression. Consisting of a methylated linear siloxane polymer containing silicon oxide, this material is composed of repeating [-(CH₃)₂-Si-O-]ₙ units and stabilized with trimethylsiloxy end groups. It provides exceptional defoaming performance in a wide range of pharmaceutical and medical processes.
Elkay Chemicals’ manufacturing facility is certified by WHO-GMP, ISO, and FDA, reflecting our commitment to global quality and safety standards. Our pharmaceutical-grade silicone product series complies with major regulatory benchmarks including IP (Indian Pharmacopoeia), BP (British Pharmacopoeia), USP (United States Pharmacopeia), and FDA guidelines—ensuring safety, efficacy, and suitability for use in pharmaceutical and cosmetic formulations.
Key features
- Highly Effective Defoamer : Provides rapid foam knockdown and long-lasting foam suppression in aqueous and non-aqueous systems.
- Dual Action Performance : Eliminates existing foam and prevents formation of new foam, even at low use levels (1–50 ppm).
- Low Volatility : Contains less than 2% volatile silicone compounds—suitable for sensitive pharmaceutical applications.
- Pharma-Grade Composition : Meets USP testing standards for Simethicone. Contains PDMS fluid and silicon oxide.
- Kosher Certification Available : Can be certified Kosher for compliance with dietary and ethical standards.
Typical Properties
| Property | Value |
|---|---|
| Appearance | Translucent grey viscous liquid |
| Solubility | Water/ethanol insoluble. Chloroform soluble |
| Defoaming Activity | Less than 15 seconds |
Applications:
Pharmaceutical Manufacturing
- Controls foam formation during formulation of syrups, suspensions, and emulsions.
- Enhances processing efficiency by reducing batch interruptions caused by foam overflow.
- Maintains product consistency and purity by preventing air entrapment.
Fermentation Processes
- Suppresses foam generated by microbial activity and gas release.
- Helps maintain sterile conditions by preventing foam from reaching vents or filters.
- Supports optimal gas exchange and nutrient delivery for higher yield.
Liquid Mixing and Maceration
- Reduces surface foam created during high-speed mixing or agitation.
- Improves ingredient dispersion and fluid homogeneity.
- Minimizes air entrapment for better product stability and shelf life.
Ampoule and Vial Filling
- Prevents foam that can lead to inaccurate filling volumes or overflows.
- Enables smooth, continuous filling without interruptions or delays.
- Reduces reject rates by ensuring clarity and uniformity in final dosage forms.
Percolation and Extraction Systems
- Controls foam in percolators and extraction vessels to maintain steady flow rates.
- Enhances solvent efficiency and extract purity by minimizing bubble formation.
- Protects sensitive bioactives from degradation caused by trapped air or foam exposure.