BRIEFING

 Ethyl Acrylate and Methyl Methacrylate (2:1) Copolymer 600000 Dispersion 30. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed.

 USP–NF currently includes the Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion monograph. These two monographs cover ethyl acrylate and methyl methacrylate copolymer dispersion excipients with the same monomer ratio but different molecular weights and different emulsifiers. Ethyl Acrylate and Methyl Methacrylate (2:1) Copolymer 600000 Dispersion 30 is an evolution of Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion. Following USP’s Excipient Nomenclature Guidelines, the USP Excipients Nomenclature and Labeling Joint Subcommittee proposed the new monograph title of Ethyl Acrylate and Methyl Methacrylate (2:1) Copolymer 600000 Dispersion 30, and the USP Nomenclature & Labeling Expert Committee approved this title.

 The test for Limit of Monomers is based on a validated HPLC method of analysis performed with the Macherey-Nagel Nucleosil C18 brand of column with L1 packing. The typical retention times for ethyl acrylate and methyl methacrylate are about 6.0 and 6.8 min, respectively.

 (CE: P. Zhang)

 Case ID—SUB-390