藥物食品檢驗局對照標準品之標定－－MICONAZOLE NITRATE

MICONAZOLE NITRATE REFERENCE STANDARD OF NATIONAL LABORATORIES OF FOODS AND DRUGS

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-); 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 'Miconazole Nitrate Reference Standard'.