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 | Guazzo, Dana Morton.
Material type: 
TextSeries: 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 | Item type | Current location | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
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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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