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Microbial Enumeration Test

#1
阿信 發表於 2018 / 04 / 11
您好: 想請問USP<61> Microbial Enumeration Test中關於樣品檢測數量的問題 敝司是API廠,檢測的數量一定是10g or 10 mL嗎? 因為有些API的dosage unit大于1mg,但單價實在太高,能否減量? 若可以減量,需要什麼依據?可以減量多少? 謝謝! USP的敘述如下: Unless otherwise directed, use 10 g or 10 mL of the product to be examined taken with the precautions referred to above. The amount to be tested may be reduced for active substances that will be formulated in the following conditions: the amount per dosage unit (e.g., tablet, capsule, injection) is less than or equal to 1 mg, or the amount per g or mL (for preparations not presented in dose units) is less than 1 mg. In these cases, the amount of sample to be tested is not less than the amount present in 10 dosage units or 10 g or 10 mL of the product. For materials used as active substances where the sample quantity is limited or batch size is extremely small (i.e., less than1000 mL or 1000 g), the amount tested shall be 1% of the batch unless a lesser amount is prescribed or justified and authorized.
管理員回覆

USP及中華藥典(第八版)都指出API批量小,則應至少使用1%,除非另有規定,正當理由或經核准,否則應用10 g或10 mL 來做驗證。建議參考中華藥典的“中文說明”,可以幫助您瞭解規定內容。
 
FROM TPDA
2018/4/16

 

 

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