藥用級妥布霉素原料CDE備案GMP認證
本品為白色或類白色的粉末，具備吸濕性。該品可在水中溶解，在乙醇中溶解程度極低。按照規范檢測方式，精準稱量本品，加水溶解并定量稀釋，配置成每1ml含40mg左右的待測溶液，依據通則0621進行測定，本品比旋度處于+138°至+148°之間。
以下兩項鑒別方式任選其一即可，均可作為本品的有效鑒別依據。
1.薄層色譜法：選取105℃活化處理2小時的硅膠G薄層板，以二氯甲烷、甲醇與濃氨溶液配比混合液作為展開溶劑。分別吸取供試品溶液、妥布霉素標準品溶液以及含卡那霉素、新霉素、妥布霉素的混合系統適用性溶液，點于同一薄層板上，完成展開、風干操作后，采用1%茚三酮的水飽和正丁醇溶液進行顯色，再經105℃加熱2分鐘。系統適用性溶液需分離出三個獨立斑點，供試品溶液顯現的主斑點，在位置與色澤上均需和標準品溶液主斑點保持一致。
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藥用級妥布霉素原料CDE備案GMP認證
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