Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

Appropriate storage conditions can only be assessed once a stability study has been conducted and it is never too early to start gathering stability data. Stability studies are a pharmacopoeial ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

There are a few scenarios where analytical procedures might need to be transferred between HPLC instruments: 1) Method transfer to new equipment in the same lab, perhaps to a different vendor or a ...

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach. Parameters affecting cleaning ...

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process. The US Pharmacopeial Convention (USP) released a general ...

In this article, the author modestly expresses his views on the use and understanding of linearity, a key parameter to be determined in analytical method validation in quality control laboratories (QC ...

Thin-layer chromatography (TLC) was widely used in the 1960s and 1970s for pesticide residue analysis, but only to a limited extent since gas–liquid chromatography (GLC) and high performance liquid ...