本文為藥物食品檢驗局對照標準品DICLOFFENAC SODIUM(批號L-1)之標定報告。其標定方法係將取得之原料藥依日本藥局方外醫藥品成分規格1989年版P.566所載之檢驗方法,予以檢驗,所得結果均符合日本藥局方外醫藥品成分規格之規定,其含為100.7%。
Diclofenae Sodium was tested for the preparation of a ”Diclofenae Sodium Reference Standard (Lot No.L-1)” of the National Laboratories of Foods and Drugs. Analytical data obtained were as follows: infrared spectrum exhibits similar wavenumbers to those stated in Japanese Standards of Pharmaceutical Ingredients; Loss on drying: 0.11%; Assay-100.7%. On the basis of these results, this material was authorized as ”Diclofenac Sodium Reference Standard”.