Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Agrochemical Functions
- CASE Ingredients Functions
- Food Ingredients Functions
- Industrial Additives Functions
- Pharma & Nutraceuticals Functions
- Plastics & Elastomers Functions
- Technologies
- Product Families
Features & Benefits
- Labeling Claims
- Agrochemicals Features
- Industrial Additives Features
Applications & Uses
- Applications
- Dosage Form
- Industrial Additives End Use
- Applications
Pharma
Properties
- Physical Form
- Typical Properties
- Microbiological Values
| Value | Units | Test Method / Conditions | |
| Active Ingredients (Simethicone) | 30 | % | USP/EP |
| Density (at 25°C) | 1 | g/cm³ | DIN 51757 |
| Emulsifier Type | Non-ionic | — | — |
| pH (at 25°C) | 3.0 - 5.0 | — | Indicator strips |
| Solids Content | 31 - 34 | % | Microwave oven |
| Value | Units | Test Method / Conditions | |
| Microbe Count | max. 100 | cfu/g | USP |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Quality Standards
- Regulatory status
Pharmaceutical use
- SILFAR® SE 8 meets the purity requirements of the monograph „Simethicone Emulsion“ under the current version of the US Pharmacopeia. A monograph for simethicone emulsions does not exist in of the European Pharmacopeia. However, the ingredients comply with the purity requirements of the corresponding monographs.
- SILFAR® SE 8, is produced under cGMP and is suitable for use as an active pharmaceutical ingredient (API) e.g. in antiflatulence and antacid preparations. It works by acting as an antifoam agent to prevent or relieve flatulence in alimentary canal and by forming a protective lining on e.g. the gastric mucous membrane. It is often combined with fermentation preparations.
- When administered to patients, preparations containing the antifoam SILFAR® SE 8 eliminate any flatulence that might hinder X-ray, ultrasonic or gastroscopic examinations. SILFAR® SE 8 may also be used to make liquid preparations in suspension form. SILFAR® SE 8 is also antifoam in fermentation and downstream processes, such as active-ingredient extraction and solvent recovery, especially when USP/EP compliant products are mandatory.
Use in food processing
- SILFAR® SE 8 is a silicone fluid emulsion based on E 900 and may be used in Europe only as a processing aid for food. Therefore, it has to be ensured by the producer of the foodstuff that only technically unavoidable traces of the product remain in the final food.
- SILFAR® SE 8 is used in strongly foaming, aqueous systems in the food sector (e.g. vegetables processing, beverages).
Contact with food
- The ingredients of SILFAR® SE 8 are contained in the positive lists of the following regulations for essential commodities intended to come into contact with food:
Germany:
- Recommendations of the BfR:
- XIV. Plastics Dispersions
- XV. Silicones
- XXXVI: Paper and Board for Food Contact
Europe:
- Regulation (EU) No. 10/2011 superseding Directive 2002/72/EC.
USA: FDA 21 CFR:
- §175.105 Adhesives
- §175.300 Resinous and polymeric coatings
- §176.170 Components of paper and paperboard in contact with aqueous and fatty foods
- §176.180 Components of paper and paperboard in contact with dry food
- §176.200 Defoaming agents used in coatings
- §176.210 Defoaming agents used in the manufacture of paper and paperboard
Regulatory sanctioning of the ingredients in a product does not imply that the finished product manufactured from those ingredients is considered safe by regulatory bodies. Responsibility for compliance with specific limits e.g. on migration extraction resides with the manufacturer of the finished product.
Use in Agrochemical formulations
- SILFAR® SE 8 meets the criteria for an exemption from the requirements of a tolerance when used as an additive in pesticide formulations to be applied to growing crops or raw agricultural commodities after harvest as specified in 40 CFR 180.910.
Packaging & Availability
- Country Availability
- Regional Availability
Storage & Handling
- Shelf Life
- 720 Days
- Storage Information
Keep container tightly closed. Store container(s) at room temperature in a dry, wellventilated place.