Pengarang: Michael J. Akers
Edisi: 2
ISBN/ISSN: 0-8247-0885-7
Penerbit: Marcel Dekker, Inc.
Tahun Terbit: 2003
Tempat Terbit: New York, Basel
Judul Seri: Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing Third Edition, Revised and Expanded
Bahasa: English
No. Panggil: PAR
GMD: Electronic Resource
Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing is a reference book that discusses quality control procedures for parenteral pharmaceutical products. Written by Michael J. Akers, Daniel S. Larrimore, and Dana Morton Guazzo, this book focuses on four essential aspects of parenteral product quality: sterility, pyrogen levels, particulate matter, and package integrity. It provides detailed explanations of sterility testing methods, including culture media, sampling procedures, incubation conditions, membrane filtration, and direct inoculation techniques. Furthermore, the book discusses pyrogen testing, including the rabbit pyrogen test and Limulus Amebocyte Lysate (LAL) test, as well as methods for detecting visible and subvisible particulate contamination. Another important topic is package integrity testing, which examines leakage detection, packaging requirements, and various testing methods to ensure product protection. This book also reviews pharmaceutical quality control standards, regulatory requirements, and technological developments related to parenteral product testing. It serves as a useful reference for pharmacy students, pharmaceutical researchers, quality control professionals, and other healthcare practitioners involved in the manufacture and evaluation of injectable pharmaceutical products.
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