USP31--A2专论.doc

Add the following: Acarbose C25H43NO18 645.60 D-Glucose, O-4,6-dideoxy-4-[[[1S-(1,4,5,6)]-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]--D-glucopyranosyl-(1?4)-O--D-glucopyranosyl-(1?4)-. O-4,6-Dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]--D-glucopyranosyl-(1?4)-O--D-glucopyranosyl-(1?4)-D-glucose [56180-94-0]. ? Acarbose is produced by certain strains of Actinoplanes utahensis. It contains not less than 95.0 percent and not more than 102.0 percent of C25H43NO18, calculated on the anhydrous basis. Packaging and storage— Preserve in tight containers. USP Reference standards 11— USP Acarbose RS. USP Acarbose System Suitability Mixture RS. Identification— A: Infrared Absorption 197K. B: The retention time of the acarbose peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. Specific rotation 781S: between +168 and +183. Test solution: 10 mg per mL, in water. pH 791: between 5.5 and 7.5, in a solution containing 50 mg per mL. Water, Method Ic 921: not more than 4.0%. Residue on ignition 281: not more than 0.2% determined on 1.0 g. Heavy metals, Method II 231: 0.002%. Chromatographic purity— Mobile phase, System suitability solution, and Chromatographic system— Proceed as directed in the Assay. Test solution— Use the Assay preparation. Diluted test solution— Transfer 1.0 mL of the Test solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Procedure— Separately inject equal volumes (about 10 μL) of the Test solution and the Diluted test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of each impurity in the portion of Acarbose taken by the formula: (1/F)(ri / rA) in which F is the relative response factor for each impurity, as listed in Table 1; ri is the individual peak response for each impurity; and rA is the respo