BRIEFING

 Acamprosate Delayed-Release Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. Based on comments received, the proposal in PF 46(6) has been canceled and is being replaced with a new proposal.

1. The liquid chromatographic procedure in the Assay was validated using the Zorbax C8 brand of column with L7 packing. The typical retention time for acamprosate is about 9 min.

2. The liquid chromatographic procedure in Dissolution, Test 1 was validated using the Luna Phenyl-Hexyl brand of column with L11 packing. The retention time for acamprosate is about 5 min.

3. The liquid chromatographic procedure in Dissolution, Test 2 was validated using the Luna Phenyl-Hexyl brand of column with L11 packing. The retention time for acamprosate is about 6 min.

4. The liquid chromatographic procedure in the test for Limit of Acamprosate Related Compound A was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for acamprosate related compound A is about 16 min.

5. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax C8 brand of column with L7 packing. The typical retention time for acamprosate is about 18 min.

 Manufacturers are encouraged to submit their FDA-approved method for Identification B to USP for consideration, if different from the one proposed, to replace the use of the toxic solvent chloroform.

 (SM4: R. Ivaturi)

 Case ID—SUB-1131, SUB-1748