本文為藥物食品檢驗局對照標準品MICONAZOLE NITRATE(批號L-1)之標定報告。其標定方法係將取得之原料藥與U.S.P.對照標準品比對,依USP XXI P.695所載之檢驗方法,予以檢驗,所得之結果均合乎USP XXI之規定,其含量為100.9%。
Miconazole Nitrate was tested for the preparation of a ”Miconazole Nitrate Reference Standard (Lot No.L-1)” of the National Laboratories of Foods and Drugs. Analytical data obtained were as follows: infrared spectrum-similar to the USP Reference Standard Miconazole Nitrate (Lot No. G-2); Chromatographic purity-Negative; Loss on drying-0.12%; Residue on ignition-0.00%; Assay-100.9%. On the basis of these results, this material was authorized as ”Miconazo1e Nitrate Reference Standard”.