BRIEFING

 Pyridostigmine Bromide Extended-Release Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product which appeared in PF 44(2) has been canceled and is replaced with a new proposal.

1. The liquid chromatographic procedure in the Assay was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for pyridostigmine is about 6 min.

2. The liquid chromatographic procedure in Dissolution Test 2 was validated using the Avantor ACE 3 C18-AR brand of column with L1 packing. The typical retention time for pyridostigmine is about 2.6 min.

3. The liquid chromatographic procedure in Dissolution Test 3 was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for pyridostigmine is about 4.5 min.

4. The liquid chromatographic procedure in the Organic Impurities test was validated using the Inertsil ODS-3 brand of column with L1 packing. The typical retention time for pyridostigmine is about 31 min.

5. The liquid chromatographic procedure in the Limit of Tetramethylurea test was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for tetramethylurea is about 32 min.

 (SM4: N. Myers)

 Case ID—SUB-621, SUB-622, SUB-1430