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Analytical chemistry an introduction to pharmaceutical GMP laboratory / Kim Huynh-Ba (editor)
Hoboken, NJ : John Wiley & Sons, Inc., 2022
xxx, 386 pages. : illustrations ; 24 cm.
Ký hiệu phân loại (DDC): 615.19
Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations.
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Handbook for chemical process research and development / Wenyi Zhao
Boca Raton, FL : CRC Press, 2023
xxxix, 825 pages. : illustrations ; 27 cm.
Ký hiệu phân loại (DDC): 615.19
This fully updated second edition reflects the significant changes in process chemistry since the first edition and includes more common process issues such as safety, cost, robustness, and environmental impact. Some areas have made notable progress such as process safety, stereochemistry, new reagents and reagent surrogates. Forty years ago there were few process research and development activities in the pharmaceutical industry, partly due to the simplicity of drug molecules. With increasing structural complexity especially the introduction of chiral centers into drug molecules and stricter regulations, process R&D has become one of the critical departments for pharmaceutical companies
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