BRIEFING

 Vinyl Alcohol Homopolymer 60000. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed.

 The US FDA Inactive Ingredients Database (IID) and GSRS databases include multiple UNII and CAS numbers for polyvinyl alcohol. These are based on the differences related to the degree of hydrolysis and average molecular weight of the said material. In the Excipient Nomenclature Guidelines, Vinyl Alcohol Homopolymer 60000 is one of the umbrella groups under Vinyl Alcohol Homopolymer that has been documented and discussed in 4.4 Nomenclature of Synthetic Polymers.

 Vinyl Alcohol Homopolymer 60000 is typically produced through polymerization of vinyl acetate. It is a type of polyvinyl alcohol with fully hydrolyzed (>99.0%) ester groups of the starting material, vinyl acetate. It possesses enhanced tensile strength and adhesive performance as compared to the partially hydrolyzed types.

 (CE: D. Chavan)

 Case ID—SUB-1370, SUB-1691