5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5Z)-;
Isopropyl (Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxybut-1-enyl]-3,5-dihydroxycyclopentyl}hept-5-enoate [209860-87-7]
BRIEFING
Tafluprost. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay and test for Organic Impurities is based on validations performed with the Accucore XL C18 brand of column with L1 packing. The typical retention time for tafluprost is about 21 min for the Assay and about 23 min for the Organic Impurities test.
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The liquid chromatographic procedure in the test for Enantiomeric Purity is based on validations performed with the Chiralcel OJ-RH brand of column with L107 packing. The typical retention time for tafluprost is about 24 min.
Description and solubility information: Colorless to light yellow viscous oil. Slightly hygroscopic. Freely soluble in absolute ethanol and practically insoluble in water.
(SM3: S. Banerjee)
Case ID—SUB-383
USP REFERENCE STANDARDS FOR PURCHASE
USP Orlistat Related Compound C RSUSP Tafluprost Enantiomer RS
USP Tafluprost RS
USP Tafluprost trans-Isomer RS