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Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide

• The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials.
• Covers heavy metals testing in the pharmaceutical industry from an historical perspective.
• Gives an overview of current USP Chapters <232> <233> and <2232> and ICH Q3D Step 4 Guidelines.
• Explains the purpose of validation protocols used in Chapter <233>, including how J-values are calculated
• Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES.
• Offers guidelines about the optimum strategy for risk assessment.
• Provides tips on how best to prepare and present your data for regulatory inspection.

https://www.crcpress.com/Measuring-Elemental-Impurities-in-Pharmaceuticals-A-Practical-Guide/Thomas/p/book/9781138197961












Contract Pharma Brasil.