Parenteral quality control : sterility, pyrogen, particulate, and package integrity testing / Michael J. Akers, Daniel S. Larrimore, Dana Morton Guazzo.

By: Akers, Michael J Contributor(s): Larrimore, Daniel S, 1975- | Guazzo, Dana Morton Material type: Text

TextLanguage: English Series: Drugs and the pharmaceutical sciences ; v. 125Publication details: New York : Marcel Dekker, c2003. Edition: 3rd edDescription: ix, 389 p. : ill. ; 24 cmISBN: 0824708857 (alk. paper); 9780824708856Subject(s): Parenteral solutions -- Analysis | Parenteral solutions -- Standards | Pharmaceutical industry -- Quality controlDDC classification: 615.19 LOC classification: RS201.P37 | A54 2003Online resources: Publisher description | WorldCat details | E-book Fulltext

Contents:

TOC 1. Sterility testing -- 2. Pyrogen testing -- 3. Particulate matter testing -- 4. Package integrity testing -- Appendixes: -- I. Example of standard operating procedure for sterility testing by direct inoculation -- II. Example of standard operating procedure for sterility testing by membrane filtration -- III. Aseptic procedures at the laminar flow workbench.

Summary: Summary: Describes the breakthroughs in the validation and execution of testing schemes for parenteral quality control. This book emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. It explains regulatory requirements and harmonization between various authorities.

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Holdings
Item type	Current library	Collection	Call number	Copy number	Status	Barcode
E-Book	EWU Library E-book	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))		Not for loan
Text	EWU Library Reserve Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-1	Not For Loan	14637
Text	EWU Library	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-2	Available	19976
Text	EWU Library Reserve Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-3	Not For Loan	19977
Text	EWU Library Circulation Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-4	Available	19978
Text	EWU Library Circulation Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-5	Available	19979
Text	EWU Library Circulation Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-6	Available	19980
Text	EWU Library Circulation Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-7	Available	21477
Text	EWU Library Circulation Section	Non-fiction	615.19 AKP 2003 (Browse shelf(Opens below))	C-8	Available	21478

Total holds: 0

Includes bibliographical references and index.

TOC 1. Sterility testing --
2. Pyrogen testing --
3. Particulate matter testing --
4. Package integrity testing --
Appendixes: --
I. Example of standard operating procedure for sterility testing by direct inoculation --
II. Example of standard operating procedure for sterility testing by membrane filtration --
III. Aseptic procedures at the laminar flow workbench.

Summary:
Describes the breakthroughs in the validation and execution of testing schemes for parenteral quality control. This book emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility. It explains regulatory requirements and harmonization between various authorities.

Pharmacy

Sagar Shahanawaz

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