该方法验证协议包括使用ThermoMax Microplate Reader和SoftMax软件对水中内毒素回收的测试要求。该方法验证的具体目标是:——验证动态浊度法鲎试剂的标记灵敏度，并通过与认证对照标准内毒素的标准曲线进行比较，验证无热原LAL试剂水没有可检测的内毒素水平--确定水系统样品对凝胶凝块反应的抑制或增强程度（如有）；以及克服抑制/增强的稀释度（如果存在）--验证将用于水系统常规内毒素测定的程序。 参考21 CFR 210.13。b、 见配套报告09-0016-PVR-1.0。

This method validation protocol includes test requirements for endotoxin recovery in water using the ThermoMax Microplate Reader and SoftMax software. Specific objectives of this method validation are: --Verifying the labeled sensitivity of the kinetic turbidimetric Limulus amebocyte lysate, and to verity that the pyrogen-free LAL Reagent Water has no detectable level of endotoxing by comparison against a standard curve of certified Control Standard Endotoxin. --Determine the degree, if any, of inhibition or enhancement of the gel-clot reaction caused by samples from the water system; and, if present, the dilution at which inhibition/enhancement is overcome. --Validating the procedure that will be used for routine endotoxin determination on the water systems. References 21 CFR 210.13.b. See companion report, 09-0016-PVR-1.0.