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EUDRAGIT® FS 30 D, the milky-white liquid of low viscosity with a faint characteristic odor is the aqueous dispersion of an anionic copolymer based on methyl acrylate, methyl methacrylate and methacrylic acid. It is insoluble in acidic media, but dissolves by salt formation above pH 7.0. Apart from its enteric properties, its dissolution at a higher pH value allows targeted colon delivery. With a glass transition temperature of 48°C, EUDRAGIT® FS 30 D is a very flexible polymer. Due to the low minimum film forming temperature only small amounts of plasticizer are required to get a smooth film formation.
Physical properties: It is a milky-white liquid of low viscosity with a faint characteristic odor.
Product Form: Aqueous Dispersion 30% Targeted Drug Release Area: Colon delivery Dissolution: pH 7.0
CAS number: 26936 – 24 – 3 Chemical/IUPAC name: Poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid) 7:3:1 INCI name: Acrylates Copolymer
Ph. Eur.: n/a USP/NF: n/a JPE: n/a
GMP standard: The Joint IPEC – PQG Good Manufacturing Practice Guide for Bulk Pharmaceutical Excipients 2006 and USP-NF General Chapter <1078>
Drug Master File: # 13941 Weight average molar mass: approx. 280,000 g/mol Acid Value: 70 mg KOH/ g polymerMinimum Film Forming Temperature (MFT): ~14°C Glass Transition Temperature (Tg): ~48°C An according EIP format is available on request.