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SILFAR® 350 is a polydimethylsiloxane derived from the hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. Its degree of polymerization (n) is adjusted to achieve a mean kinematic viscosity of 350 mm²/s at 25°C. This versatile product finds application in both the pharmaceutical and food sectors. In the pharmaceutical industry, it is commonly used in antiflatulence and antacid preparations.

Ingredient Name: Polydimethylsiloxane

Chemical Name: Polydimethylsiloxane

CAS Number: 9006-65-9

Functions: Anti-Foaming Agent, Defoamer

Chemical Family: Siloxanes

Dosage Form: Tablets

Synonyms: Dimethicone

Technical Data Sheet

Knowde Enhanced TDS

Identification & Functionality

Chemical Family
Ingredient Name
CASE Ingredients Functions
Food Ingredients Functions
Industrial Additives Functions
Pharma & Nutraceuticals Functions
Plastics & Elastomers Functions
CAS No.
9006-65-9
Food Additive Number
E 900a, INS 900 a
Ingredients
Dichlorodimethylsilane, Chlorotrimethylsilane
EC No.
618-433-4
Chemical Structure

SILFAR® 350 - Chemical Structure

Features & Benefits

Food Ingredients Features
Industrial Additives Features
Materials Features

Applications & Uses

Dosage Form
Food & Nutrition Applications
Industrial Additives End Use
Plastics & Elastomers End Uses
Application Details
  • SILFAR® 350 is used both in the pharmaceutical and food sectors. In the pharmaceutical sector it is used in antiflatulence and antacid preparations. It acts as an antifoam agent to prevent or relieve flatulence in the alimentary canal and forms a protective lining on e.g. the gastric mucous membrane.
  • SILFAR® 350 may be used to make tablets and coated tablets. It is often combined with fermentation preparations.
  • SILFAR® 350 is also used to control foam in fermentation and downstream processes, such as active-ingredient extraction and solvent recovery, especially when USP/EP compliant products are mandatory.
  • In the food sector, SILFAR® 350 is used predominantly to control foam in lipophilic systems (foods rich in oil or fat, e.g. deep-frying oil) or for surface treatment. SILFAR® 350 also serves as the base material in the production of antifoams compliant with the regulations pertaining to food for human consumption.
Applications
  • Food
  • Pharma

Properties

Odor
Odorless
Typical Properties
ValueUnitsTest Method / Conditions
Aciditymax. 5mg/kgDirect Titration Method
Active Substance100%
Density (at 25°C)0.965 - 0.973 g/cm³DIN 51757
Flash Pointmin. 300 °CISO 2592
Ignition Temperature450°CDIN 51794
Kinematic Viscosity (at 25°C)333 - 367 mm²/sDIN 53019
Refractive Index (at 25°C)1.402 - 1.404
Solidification Point-50°C
Volatile Contentmax. 0.3 %USP

Regulatory & Compliance

Regulatory status

Use as pharmaceutical excipient:

SILFAR® 350 complies with the requirements set down in the monographs Dimeticone (EP) and "Dimethicone" (USP / NF). Wacker explicitly rules out the use of SILFAR® 350 for parenteral applications.

Direct Food additive:

  • SILFAR® 350 is listed in the Regulation (EC) No 1333/2008 Annex II and III as amended by Regulations (EU) Nos 1129/2011 and 1130/2011 as E 900 polydimethylsiloxane. It meets the purity requirements as laid down in Regulation (EU) No. 231/2012 and is therefore approved as direct food additive within the EC under observance of the use restrictions in force for polydimethylsiloxane (E 900).
  • SILFAR® 350 is certified according to HACCP principles. Hence, it meets the requirements on food hygiene in accordance with Regulation (EC) No. 852/2004.

Food Contact:

SILFAR® 350 complies with the Recommendation "XV Silicones" of the BfR concerning the manufacture of essential commodities that have contact with food. SILFAR® 350 is listed under PM-Nr. 76721 in Regulation (EU) No. 10/2011 as an additive for plastic materials to come into contact with food and meets the specifications under column (4) and (10). The product is not subject to a specific migration limit (SML). SILFAR® 350 is suitable for use under FDA 21 CFR as follows:

  • §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)
  • §177.1210 (Closures with sealing gaskets for food containers).
  • §177.2800 (Textiles and textile fibers).
  • §178.3120 (Animal glue).
  • §178.3570 (Lubricants with incidental food contact)
  • §178.3910 (Surface lubricants used in the manufacture of metallic articles)
  • §181.28 (Release agents)

SILFAR® 350 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 CR 180.960.

Packaging & Availability

Country Availability
Regional Availability
  • Africa
  • Asia
  • Europe
  • Latin America
  • Middle East
  • North America
  • Oceania

Storage & Handling

Shelf Life
720 Days
Storage Information

Keep container tightly closed. Store container(s) at room temperature in a dry, wellventilated place.