4-Quinazolineacetic acid, 8-fluoro-3,4-dihydro-2-[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-, (4S)-;
(S)-2-{8-Fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid [917389-32-3]
BRIEFING
Letermovir. 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 used in the Assay was validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for letermovir is about 6 min.
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The liquid chromatographic procedure used in the Limit of Rivastigmine Related Compound A test was validated using the Kromasil 100-5-C18 brand of column with L1 packing. The typical retention time for rivastigmine related compound A is about 20 min.
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The liquid chromatographic procedure used in the Organic Impurities test was validated using the Ultisil XB-C18 brand of column with L1 packing. The typical retention time for letermovir is about 51 min.
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The liquid chromatographic procedure used in the Limit of Letermovir R-Enantiomer test was validated using the Chiralpak IC-3 brand of column with L119 packing. The typical retention times of letermovir R-enantiomer and letermovir are about 14 and 33 min, respectively.
This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.
Description and solubility information: Off-white to white powder. Soluble in acetonitrile and isopropyl alcohol; insoluble in n-heptane.
(SM1: J. Kilari)
Case ID—SUB-1239, SUB-2882