In a study published in Analytical Methods, a research group led by Li Bei from the Changchun Institute of Optics, Fine Mechanics and Physics (CIOMP) of the Chinese Academy of Sciences (CAS) proposed ...

When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect. Analytical method transfer suffers from many of the same ...

Calibration in analytical chemistry is fundamental to quantifying substances and ensuring the metrological integrity of measurement systems. By establishing a reliable relationship between the ...

Often, transferring an analytical method from R&D to quality control fails; success depends on determining where “the best” and “the most reliable” intersect. Analytical method transfer suffers from ...

These must report preliminary research findings that are highly original, of immediate interest and are likely to have a high impact. Communications are given priority treatment, are fast-tracked ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

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 ...

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 ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...