EUDRAGIT® RL 100

EUDRAGIT^® RL 100 is a copolymer of ethyl acrylate, methyl methacrylate and a low content of methacrylic acid ester with quaternary ammonium groups. The ammonium groups are present as salts and make the polymers permeable.

Physical properties: It is is a solid substance in form of colourless, clear to cloudy granules with a faint amine-like odour.

Chemical structure:

Product Form: Granules
Targeted Drug Release Area: Time controlled release, pH independent
Dissolution:

• Insoluble
• High permeability
• pH independent swelling

Characteristics:

• Customized release profile by combination of RL and RS grades in different ratios
• Suitable for matrix structures

CAS number: 33434 – 24 – 1
Chemical/IUPAC name: Poly(ethyl acrylate-co-methyl methacrylate-co-trimethylammonioethyl methacrylate chloride) 1:2:0.2
INCI name: Acrylates / Ammonium Methacrylate Copolymer 
 

Monographs:

        Ph. Eur.: Ammonio Methacrylate Copolymer, Type A
        USP/NF: Ammonio Methacrylate Copolymer, Type A - NF
        JPE: Aminoalkyl Methacrylate Copolymer RS

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
Molecular weight information: approx. 32,000 g/mol
Alkali Value: 28,1 mg KOH/ g polymer
Glastransition Temperature (Tg): ~70°C

AN according EIP format is available on request.