Product description: SILFAR® 500 is a polydimethylsiloxane obtained by hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. The degree of polymerization (n) is such that the mean kinematic viscosity is 500mm² /s at 25°C.

Properties: Regulatory status Use as pharmaceutical excipient: SILFAR® 500 complies with the requirements set down in the monographs "Dimeticone" (EP) and "Dimethicone" (USP / NF). Wacker explicitly rules out the use of SILFAR® 500 for parenteral applications. Direct Food additive: SILFAR® 500 conforms to FDA 21 CFR § 173.340 "Defoaming Agents" as a "Secondary Direct FoodAdditive Permitted in Food for Human Consumption." SILFAR® 500 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® 500 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® 500 complies with the Recommendation "XV Silicones" of the BfR concerning the manufacture of essential commodities that have contact with food. SILFAR® 500 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® 500 is suitable for use under FDA 21 CFR

Application: SILFAR® 500 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® 500 may be used to make tablets and coated tablets. It is often combined with fermentation preparations. SILFAR® 500 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® 500 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® 500 also serves as the base material in the production of antifoams compliant with the regulations pertaining to food for human consumption.

Information provided by Wacker Chemie AG.