Regulatory Validation of Stability-Indicating Methods in Pharmaceuticals
Regulatory Validation of Stability-Indicating Methods in Pharmaceuticals How to Validate Stability-Indicating Methods for Regulatory Approval Introduction Stability-indicating methods (SIMs) are essential analytical tools used to monitor the potency and purity of pharmaceutical products throughout their shelf life. These methods must not only quantify the active pharmaceutical ingredient (API) but also accurately detect and resolve any…
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