EP5.1.10细菌内毒素测试使用指南(中英文2)技术方案.docVIP

EP 5.1.10 细菌内毒素测试使用指南（中英文2/2）?? 2015-12-28 23:00:31|??分类：?EP For routine tests on this product, it may be expedient to dilute 1 mL of the solution to be examined to 20 mL (MVD/2 rounded to the next lower whole number). However, if this test result is positive the analyst will have to dilute 1 mL to 41.67mL and repeat the test. A dilution to 41.67 mL is also necessary when the test is performed to settle a dispute. 对于此药品的日常检查，可以取1ml供试液稀释至20ml（MVD/2四舍五入至最接近的整数）。但是，如果该测试结果为阳性，则化验室要稀释1ml至41.67ml，重复测试。如果有争议，仲裁测试也必须使用41.67ml的稀释。 3. RISK ASSESSMENT?风险评估 As stated in section 1 of this general chapter