5H-Dibenz[b,f]azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro, (10S)-;
(S)-5-Carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate [236395-14-5]
BRIEFING
Eslicarbazepine Acetate. 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 is based on analyses performed with the Inertsil ODS-3V brand of column with L1 packing. The retention time for eslicarbazepine acetate is about 11 min.
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The liquid chromatographic procedure in the Organic Impurities test is based on analyses performed with the Symmetry Shield RP 8 brand of column with L7 packing. The retention time for eslicarbazepine acetate is about 14 min.
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The liquid chromatographic procedure in the Enantiomeric Purity test is based on analyses performed with the Chiralpak AD-H brand of column with L51 packing. The retention time for eslicarbazepine acetate is about 20 min.
Description and Solubility information: White to off-white, odorless crystalline solid. Soluble in organic solvents such as in acetone, in acetonitrile, and in methanol; very slightly soluble in aqueous solvents; insoluble in hexane.
(SM4: G. Hsu)
Correspondence Number—C143225
USP REFERENCE STANDARDS FOR PURCHASE
USP Eslicarbazepine Acetate Chiral Peak ID Mixture RSUSP Eslicarbazepine Acetate Peak ID Mixture RS
USP Eslicarbazepine Acetate RS