要依据美国食榀、药榀、化让路法案501款以及美国药典和国家处方集的各论中的含量测定和质量标准来构建法定标准。
According to Section 501 of the Federal Food Drug and Cosmetic Act assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards.
结论药典法定剂量的关木通水煎剂对大鼠肾功能及肾间质结构无明显的不利影响。
Condusion There is no significant adverse effect of CAM decoction on renal function and interstitial structure in rats at statutory dose according to pharmacopoeia.
该药典中允许通过非法定的方法检测外来物质。
Allowance is made in this Pharmacopeia for the detection of foreign substances by unofficial methods.
方法采用《中国药典》2005年版二部动态浊度法定量检测细菌内毒素含量。
Methods the turbidimetric kinetic assay was adopted to quantitatively analyze the content of bacterial endotoxin, according to China Pharmacopoeia (2005 Edition 2).
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。
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。
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.
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