EUDRAGIT® E 100

EUDRAGIT^® E 100 is a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate.
 
Physical Description: Itconsists of colourless to yellow tinged granules with a characteristic amine-like odor.

Chemical structures:

Product Form: Granules
Targeted Drug Release Area: Stomach
Dissolution:

• Soluble in gastric fluid up to pH 5.0
• Swellable and permeable above pH 5.0

Characeristics:

• Low viscosity, high pigment binding capacity, good adhesion
• low polymer weight gain

CAS number: 24938-16-7
Chemical/ IUPAC name: Poly(butyl methacrylate-co-(2- demethylaminoeethyl) methacrylate-co-methyl methacrylate) 1:2:1
INCI name: Acrylates/ Dimethylaminoethyl Methacrylate Copolymer

Monographs:

        Ph. Eur.     Basic Butylated Methacrylate Copolymer
        USP/NF      Amino Methacrylate Copolymer-NF
        JPE           Aminoalkyl Methacrylate Copolymer E

GMP standard: The joint IPEC-PQG Good Manufacturing Practice Guide for Bulk Pharmaceutical Excipients 2006 and USP-NF General Chapter <1078>

Drug Master File: # 1242
Weight average molar mass: Mw approx. 47,000 g/ mol
Alkali Value: 180 mg KOH/ g polymer
Glass Transition Temperature (Tg): ~ 48°C


An according EIP format is available on request.