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Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations by Rubén M. Maggio & Silvana E. Vignaduzzo & Teodoro S. Kaufman

Author:Rubén M. Maggio & Silvana E. Vignaduzzo & Teodoro S. Kaufman , Date: February 12, 2022 ,Views: 11

Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations by Rubén M. Maggio & Silvana E. Vignaduzzo & Teodoro S. Kaufman

Author:Rubén M. Maggio & Silvana E. Vignaduzzo & Teodoro S. Kaufman
Format: pdf
Tags: Degradation, Drug assay, Drug quality, Drug safety, Drug stability, Impurity, Pharmaceutical regulation, Regulatory consideration, Stability-indicating method (SIM), Stress testing
Publisher: Elsevier Ltd
Published: 2013-08-06T03:58:36+00:00


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Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations by Rubén M. Maggio & Silvana E. Vignaduzzo & Teodoro S. Kaufman.pdf


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