BRIEFING
Ibandronate Sodium Injection. 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 46(4) [July–Aug. 2020] was canceled and is replaced with a new proposal.
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The liquid chromatographic procedure in the Assay is validated using the Allsep Anion brand of column with L23 packing. The typical retention time for ibandronic acid is about 12 min.
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The liquid chromatographic procedure in the Organic Impurities test is validated using the Inertsil C8-3 brand of column with L7 packing. The typical retention time for ibandronic acid is about 7 min.
(SM3: R. Fales)
Case ID—SUB-767