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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: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 125. Publisher: New York : Marcel Dekker, c2003Edition: 3rd ed.Description: ix, 389 p. : ill. ; 24 cm.ISBN: 0824708857 (alk. paper); 9780824708856.Subject(s): Parenteral solutions -- Analysis | Parenteral solutions -- Standards | Pharmaceutical industry -- Quality controlDDC classification: 615.19 Online resources: Publisher description | WorldCat details | E-book Fulltext
Contents:
Table of contents 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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Non-fiction 615.19 AKP 2003 (Browse shelf) Not for loan
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Text Text EWU Library
Non-fiction 615.19 AKP 2003 (Browse shelf) C-2 Available 19976
Text Text EWU Library
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Non-fiction 615.19 AKP 2003 (Browse shelf) C-3 Not For Loan 19977
Text Text EWU Library
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Non-fiction 615.19 AKP 2003 (Browse shelf) C-4 Available 19978
Text Text EWU Library
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf) C-5 Available 19979
Text Text EWU Library
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf) C-6 Available 19980
Text Text EWU Library
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf) C-7 Available 21477
Text Text EWU Library
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf) C-8 Available 21478
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615.19 AGP 2000 Physical pharmacy / 615.19 AGP 2000 Physical pharmacy / 615.19 AKP 2003 Parenteral quality control : 615.19 AKP 2003 Parenteral quality control : 615.19 AKP 2003 Parenteral quality control : 615.19 AKP 2003 Parenteral quality control : 615.19 AKP 2003 Parenteral quality control :

Includes bibliographical references and index.

Table of contents 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

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