Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method
A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...
It also addresses limitations of the current method and explores strategies to improve its robustness and reliability, leveraging the capabilities of the Fourier 80. With its compact, cryogen-free ...
Challenging method conditions can impact autosampler performance on High-Performance Liquid Chromatography (HPLC) systems. Methods with highly organic sample diluents, coupled with low injection ...
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