Control Method-Related Data Quality Risks During Chromatographic Analysis with Fit-for-Purpose, High Quality Vials

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Tran Pham and Markus Wanninger
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White Papers

This paper focuses on the use of glass vials for LC and LC/MS small molecule applications.

The case studies in this paper illustrate the types of issues that occur when using poor quality vials. These case studies prove that the root cause for poor data quality is poor quality vials. Methods for choosing the appropriate vial type to control the risks of these issues from occurring are also discussed.

It has been shown that vial quality does have an impact on data quality and should be considered when assessing method-related risks during Stage 1 of MLCM: Method Design and Development. Choosing the right vial, cap and septa for sample analysis is important to ultimately achieve and maintain good method performance and is essential for method robustness. The sample vial coming from a single, specified source also reduces risks when the sample methods needs to be deployed to different laboratories across the globe.

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