drug substance 药品
- These limits are normally applied to related substances in the drug substance or drug product.
这些检测通常适用于原料药或制剂中有关物质的检测。 - The drug substance for a pharmaceutical product eligible for ANDA status normally is an official article and should be well characterized analytically.
符合ANDA状态的制剂的原料药通常是法定的药品并应很好的分析其特点。 - This would be particularly true for the bulk drug substance manufacturer where reactors and centrifuges and piping between such large equipment can be sampled only using rinse solution samples.
尤其对那些原料药生产商来说,反应物,反应堆或设备间的管道系统可以只是用冲洗溶液样品取样,这样做就很正确了。
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