Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.

Language: English

Published by Marcel Dekker, New York, 2002

0824708857 / 9780824708856

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Seller: Fox and Tome Books, Frederick, MD, U.S.A.Fox and Tome Books

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Item description from seller

By Michael K. Akers, Dan Larrimore and Dana Guazzo, this is a working reference on the tests used to show that finished injectable products are sterile, free of pyrogens and free of particles. Separate long chapters cover sterility testing, pyrogen testing and particulate matter testing, and container package integrity is treated as well. The authors set the official compendial tests beside the debate over how reliable, sensitive and applicable they are. Throughout, they stress test methods that meet both U.S. and European requirements, along with newer technologies for testing the finished product. Considerable space goes to barrier isolation systems for sterility testing. It covers how to qualify and validate them, and the regulators' worry that surface decontamination inside an isolator can produce false-negative results. Feel free to ask for photos or more detail.

Seller Inventory # OA-240306-shelf-29-027

Title
Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.
Author
Michael K. Akers, Daniel S. Larrimore and Dana Morton Guazzo
Publisher
Marcel Dekker, New York
Publication year
2002
Condition
New
Binding
Hardback
Language
English
ISBN 10
0824708857
ISBN 13
9780824708856
Edition
3rd Edition
Item weight
2.5 pounds
Dimensions
14.0 x 14.0 x 4.0 inches
Seller catalogs
Medicine, Medicine & Health

Fox and Tome Books

Frederick, MD, U.S.A.

4-star seller

AbeBooks seller since March 2, 2023

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Fox and Tome Books is an independent bookshop in Frederick, Maryland, 13 years in the trade. Genres runs wide : history, military, art, photography, science and medicine, religious studies of all faiths, occult, scholarship and reference, signed copies, first editions, scarce and out-of-print. Every book is hand inspected, accurately described and shipped with care. Please inquire about any item for details or additional photos. Thanks. -Brandon

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