本文為藥物食品檢驗局對照標準品TOLNAFTATE(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.對照標率品比對,依USPXXIP.1071-1072所載之檢驗方法,予以檢驗,所得之結果均合乎USPXXI之規定,其含量為99.4%。
Tolnaftate was tested for the preparation of a ”Tolnaftate Reference Standard (Lot No. L-1)” of the National Laboratories of Foods and Drugs. Analtical data obtained were as follow: infrared spectrum-similar to the USP Tolnaftate Reference Standard Chromatographic Loss on drying-0.18%; Rreidue of ignition-0.08%; Assay-99.4%. On the basis of these results, this material was authorized as ”Tolnaftate Reference Standard”.