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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 JContributor(s): Larrimore, Daniel S, 1975- | Guazzo, Dana MortonMaterial type: TextTextLanguage: 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 Date due Barcode Item holds
E-Book E-Book Dr. S. R. Lasker Library, EWU
E-book
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) Not for loan
Text Text Dr. S. R. Lasker Library, EWU
Reserve Section
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-1 Not For Loan 14637
Text Text Dr. S. R. Lasker Library, EWU
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-2 Available 19976
Text Text Dr. S. R. Lasker Library, EWU
Reserve Section
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-3 Not For Loan 19977
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-4 Available 19978
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-5 Available 19979
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-6 Available 19980
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.19 AKP 2003 (Browse shelf(Opens below)) C-7 Available 21477
Text Text Dr. S. R. Lasker Library, EWU
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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