2H-1-Benzopyran-2-methanol, α,α′-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro]-, hydrochloride, (αR,α′R,2R,2′S)-rel-;
(1RS,1’RS)-1,1’-[(2RS,2’SR)-Bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2’-iminodiethanol hydrochloride [152520-56-4]
BRIEFING
Nebivolol Hydrochloride. 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] has been canceled and is being replaced with a new proposal. The new proposal includes changes to the Organic Impurities test and clarification to the chemical information under the Stereoisomeric Purity test and USP Reference Standards section.
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The liquid chromatographic procedure in the Assay and the test for Organic Impurities was validated using the XTerra MS C18 brand of column with L1 packing. The typical retention time for nebivolol is about 13 min.
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The liquid chromatographic procedure in the test for Stereoisomeric Purity was validated using the Chiralpak AD brand of column with L51 packing. The typical retention times for d-nebivolol and l-nebivolol are about 11 and 13 min, respectively.
Description and Solubility information: White to almost white powder. Freely soluble in dimethylsulfoxide; soluble in N,N-dimethylformamide; sparingly soluble in methanol; slightly soluble in ethanol, in propylene glycol, and in polyethylene glycol 400; very slightly soluble in 2-propanol and in water; insoluble in acetonitrile, in tetrahydrofuran, in methylene chloride, in hexane, in ethyl acetate, and in methylbenzene.
(SM2: S. Ramakrishna)
Correspondence Number—C181257
USP REFERENCE STANDARDS FOR PURCHASE
USP Nebivolol Stereoisomer Mixture RSUSP Nebivolol Hydrochloride RS
USP Nebivolol Related Compound A RS
USP Nebivolol Related Compound E RS