In your response, please provide evidence that all lots of (b)(4) API manufactured and within expiration comply with the USP compendial requirements.
在你的回复中，请提供所有（b）（4） API的生产及其有效期内其质量均符合USP摘要要求的证据。
2
In the case of procedures submitted for consideration as official compendial procedures it is almost never necessary to determine the actual quantitaion limit.
对于提交用于官方药典规程的备选方法，其几乎从来不需要确定实际的检测限度。
3
The existence of compendial limits or tolerances does not constitute a basis for a claim that an official substance that more nearly approaches 100 percent purity "exceeds" the Pharmacopeial quality.