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本帖最后由 wendysmile 于 2015-9-11 13:51 编辑
卡那霉素冻干粉,含量的接受标准如下: Assay Carryout the assay as described under 3.1Microbiological assay of antibiotics using either (a)Bacillus subtilis (ATCC 6633) as the test organism, culture medium Cm1 with afinal pH of 7.9, sterile phosphate buffer pH 8.0 TS1, an appropriateconcentration of kanamycin (usually 5–20 IU per mL) and an incubationtemperature of 30–37 °C, or (b) Staphylococcus aureus (ATCC 6538 P) as the testorganism, the same culture medium and phosphate buffer, an appropriateconcentration of kanamycin (usually 10 IU per mL) and an incubation temperatureof 35–39 °C.The precision of the assay is such that the fiducial limits of error of the estimated potency (P = 0.95) are not less than 95% and not more than 105% of the estimated potency. The upper fiducial limit of error of the estimated potency (P = 0.95) is not less than 90.0% and the lower fiducial limit of error is not more than 120.0% of thestated number of International Units. 麻烦各位帮忙解释标黄这句话到底怎么理解,标准到底应该定多少?万分感谢。
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