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snrtgefssy

金虫 (小有名气)

[求助] 固体制剂生产中API的投料量问题

各位站友:
本人一直存在疑惑,在化药的固体制剂商业化生产中API的投料量是按处方量的100%进行投料,还是按原料实际检测含量折算(折纯折干)后进行投料。去过几家公司,上述两做法都有,故想问下,国家有无法规或指导原则进行规定,请说明下来源,谢谢!另外,国内和国外做法是否存在差别?
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wzq_2004608

至尊木虫 (小有名气)

【答案】应助回帖

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snrtgefssy: 金币+2, ★有帮助 2012-07-27 13:07:18
我们国内国外都做过,无差别。按照COA中API含量折纯折水后100%投料,当然要看检测时是否已折水。
2楼2012-07-26 00:07:23
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