myreebok
第3楼2010/11/23
2. Adjustments to chromatographic systems performed in order to comply with system suitability
requirements are not to be made to compensate for column failure or system malfunction.
为达到系统适应性要求调整色谱系统不是为了补偿柱损坏或系统误故障。
3. The changes described below may require additional validation data. The user should verify the
suitability of the method under the new conditions by assessing the relevant analytical performance
characteristics potentially affected by the change.
以下描述的变更可以需要额外的验证数据。使用者应在新的条件下用评估变更对相关分析性能参数产生的可能地影响来核实方法的的适用性
影子
第6楼2010/11/23
根据日常习惯,可否作一下小小的调整:
以下描述的变更可能需要额外的验证数据。使用者应在新的条件下,通过评估变更对相关分析性能参数产生的可能的影响来确认方法的的适用性
poorlittle
第8楼2010/11/24
Adjustments are permitted only when suitable standards (including Reference Standards) are available for all compounds used in the suitability test and only when those standards are used to show that the adjustments have improved the quality of the chromatography in meeting system suitability requirements.
只有当适用性检验中的所有化合物均有适用之标准(包括参考标准),且该等标准能证明通过调整可改善色谱仪之适用性, 方可调整。