How do I generate authentic Chromatographic results?
As an analytical chemist your primary concern is to generate authentic data which is universally accepted and reproducible under identical conditions in any other laboratory. Even the use of most sophisticated instruments will not serve the purpose if globally accepted norms are overlooked. System suitability is the key to generation of valid data in chemical analysis.
色谱法，特别是液相色谱，是从事药品，食品，取证，聚合物，生命科学和环境研究的实验室中最流行的技术。成千上万的HPLC正在在世界各地的药品部门的研发和质量控制实验室工作。每天产生巨大的数据，这有助于为人类消费发育安全和有效的药物。鉴于这种活动的严重性，HPLC系统应该满足在根据此类数据的决策之前满足系统适用性的要求。
什么是系统适用性？
System suitability tests constitute significant part of chromatographic analysis. They help us decide that the detection sensitivity, resolution, and reproducibility are adequate for the required analysis. The United States Pharmacopoeia (USP) is an authoritative source for guidelines on chromatography of the drug substances. Section 621 USP states that system suitability tests are an integral part of gas and liquid chromatography analysis. The tests are based upon the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such. This means that no sample analysis is acceptable unless the requirements of system suitability have been met.
Factors contributing to system suitability failures in HPLC analysis
- 自动采样器 - 由于无法提供精确的样本和标准的卷，因此精度差。
- Columns – ageing columns or choked columns can result in poor performance due to reduction in theoretical plate count.
- Pumps – failure to deliver constant flow rate of mobile phase due to wear and tear of the operating parts
- 移动相位 - 制定规定混合物和不完全脱气的误差
- 样品和参考准备 - 注射前的制备或非过滤的不准确性
How often is system suitability testing required?
As per regulatory bodies guidelines system suitability should qualify the entire chromatographic system and not just individual modules. Whenever there is a significant change in equipment or in a critical reagent system suitability testing should be done before injection of the samples. No sample analysis is acceptable unless the requirements of system suitability have been met. Sample analysis results obtained while system is failing requirements of system suitability are of no significance.
系统适用性必须在所有调节的测定之前和整个中进行。在色谱运行开始时应用适用性测试并不足以假设系统在运行期间将正常执行。含有主要成分和预期杂质的试验混合物可以在开始时喷射并在测试期间散布。
On facing system suitability failure the analyst should stop the analysis immediately. After diagnosing the problem and taking remedial measures the suitability testing should be redone. Analysis of actual samples should be resumed only after all system suitability criteria are met and not only the failed criteria.
我们用标准溶液或样品（例如等离子体样品）进行系统合适测试系统是否有任何指导能够遵循系统适用性测试？
System suitability is usually run with standards to check the performance of the cinematographic system while Quality control samples are used to check the performance of the entire method (sample preparation and the chromatography) and thus both should be run in a sequence.
感谢您的信息。
it is very interesting
Thanks for your appreciation.catch up on the second part published yesterday.
Dear Sir,
是否有任何特殊点，其他人在文章中表示，在外包HPLC分析QC目的时必须注意到？
Kindly respond.
亲切的问候
Hi,
在外包HPLC分析时，除了文章中涵盖的点，您应该确保外包实验室或者您推荐的方法是验证的方法，也是在进行的分析师接受了足够的培训水平，他的专业知识验证。
最好的祝福
Dear Sir,
非常感谢你的回复。
I will find ways of working upon the same.
最好的祝福
非常感谢您发布有价值的信息。
很高兴地注意到您发现信息有用。
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