Phosphonic acid, [1-hydroxy-3-(methylpentylamino)propylidene]bis-, monosodium salt, monohydrate;
Sodium trihydrogen [1-hydroxy-3-(methylpentylamino)propylidene]diphosphonate, monohydrate [138926-19-9]
BRIEFING
Ibandronate Sodium. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 47(6) [Nov.–Dec. 2021] was canceled and is replaced with a new proposal.
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The liquid chromatographic procedures in the Assay and Limit of Phosphate and Phosphite test are validated using the Allsep Anion brand of column with L23 packing. The typical retention time for ibandronate in the Assay and Limit of Phosphate and Phosphite test is about 8 and 16 min, respectively.
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The liquid chromatographic procedure in the test for Organic Impurities is validated using the Inertsil C8-3 brand of column with L7 packing. The typical retention time for ibandronate is about 7 min.
Description and Solubility information: White to off-white powder. Freely soluble in water; practically insoluble in methanol and in organic solvents.
(SM3: R. Fales)
Correspondence Number—C298042
USP REFERENCE STANDARDS FOR PURCHASE
USP Ibandronate Related Compound A RSUSP Ibandronate Sodium RS
USP Phosphoric Acid RS