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。
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。
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.
药典限度或允许偏差的存在不能说明一个接近100%纯度的法定物质是超过药典的质量。
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