Solution A: Acetonitrile and Buffer (20:80) Solution B: Acetonitrile and Buffer (80:20) Mobile phase: See Table 1. PROCEDURE Buffer: Dissolve 1.96 g of orthophosphoric acid and 0.34 g of tetrabutylammonium hydrogen sulfate in 1000 mL of water.The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. Gonikberg.) Correspondence Number-C89258ĭEFINITION Aprepitant contains NLT 98.0% and NMT 102.0% of C23H21F7N4O3, calculated on the anhydrous basis. Reagents: Orthophosphoric acid (phosphoric acid, crystalline), H3PO4-98.00 -Use a suitable grade with a content of NLT 98%. The typical retention time for aprepitant is 15 min. The HPLC procedure in the test for Enantiomeric Purity is based on analysis performed with the Chiralpak AD-H brand of L51 column. The typical retention time for the aprepitant peak is 14 min. The HPLC procedures in the Assay and the test for Organic Impurities are based on analyses performed with the Hypersil BDS C8 brand of L7 column. The limit of total impurities remains unchanged. An additional specified impurity, desfluoro aprepitant, is added to the Table 2 in Organic Impurities with the limit of NMT 0.15%. Concentration of USP Aprepitant RS in the System suitability solution is lowered from 1.0 mg/mL to 0.5 mg/mL. To address this comment, a quantitation of impurities is now performed using an external standard approach, against the Standard solution with the concentration equivalent to 0.1% of the Sample solution. Comments were received that the response of the aprepitant peak in the Sample solution in Organic Impurities is above 2 AU and outside of the linear range of a typical HPLC instrumentation, which may affect calculation of the impurities by area normalization approach. In the Chemical Information section, the chemical structure is corrected to be consistent with the structure in the USP Dictionary, and a fourth chemical name is added. The following is a summary of changes to the Draft USP Pending Monograph approved by the Expert Committee: 1. The SM3 Expert Committee has reviewed all comments received and approved the monograph as an Authorized USP Pending Monograph. This monograph was posted on the USP Website as a Draft USP Pending Monograph and has been available for public comment for more than 90 days. Authorized USP Pending Monograph Version 1īRIEFING Aprepitant.
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