Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing - Couverture rigide
Synopsis
Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.
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Présentation de l'éditeur
Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences)
Edité par
CRC Press, 2002
ISBN 10 : 0824708857
ISBN 13 : 9780824708856
Ancien ou d'occasion
Couverture rigide
Vendeur : ThriftBooks-Atlanta, AUSTELL, GA, Etats-Unis
Évaluation du vendeur 5 sur 5 étoiles
Hardcover. Etat : Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. N° de réf. du vendeur G0824708857I3N00
Acheter D'occasion
EUR 36,02
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.; Larrimore, Dan and Guazzo, Dana
Edité par
Marcel Dekker, 2003
ISBN 10 : 0824708857
ISBN 13 : 9780824708856
Ancien ou d'occasion
Couverture rigide
Vendeur : Fox and Tome Booksellers, Frederick, MD, Etats-Unis
Évaluation du vendeur 4 sur 5 étoiles
Hardback. Etat : Good. Shows minor wear to the cover and pages. Pages have highlighting/margin notes/underlining or any combination. The binding is fully intact and secure. This is a good reading or studying copy and has been verified that all pages are legible. 100% satisfaction guaranteed! --- Part of Marcel Dekker's Drugs and the Pharmaceutical Sciences series, this 2003 volume by Michael J. Akers, Daniel Larrimore, and Dana Morton Guazzo addresses the quality control procedures used to verify that injectable pharmaceuticals are sterile, nonpyrogenic, and free of particulate contamination. The text examines validation strategies and analytical approaches for assessing finished product contamination, container closure integrity, and microbial sterility, while reviewing the regulatory frameworks of both US and European authorities and efforts toward international harmonization. It serves as a technical reference for professionals engaged in parenteral manufacturing, quality assurance, and compliance. N° de réf. du vendeur OA-250202-shelf-36-015
Acheter D'occasion
EUR 36,03
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences) Akers, Michael K.; Larrimore, Dan and Guazzo, Dana
Vendeur : Fox and Tome Booksellers, Frederick, MD, Etats-Unis
Évaluation du vendeur 4 sur 5 étoiles
Hardback. Etat : New. Authored by Michael J. Akers, Daniel Larrimore, and Dana Morton Guazzo and published by Marcel Dekker in 2003 as part of the Drugs and the Pharmaceutical Sciences series, this reference examines the principal quality control tests applied to injectable pharmaceutical products. It covers sterility assurance, pyrogen and endotoxin detection, particulate matter analysis, and container-closure integrity evaluation, addressing both validation approaches and routine application of these methods. The text discusses compliance with United States and European regulatory expectations, along with efforts toward harmonization of compendial standards across jurisdictions. N° de réf. du vendeur OA-240306-shelf-29-027
Acheter neuf
EUR 86,70
Livraison gratuite
Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing (Drugs and the Pharmaceutical Sciences)
Vendeur : SHIMEDIA, Brooklyn, NY, Etats-Unis
Évaluation du vendeur 5 sur 5 étoiles
Etat : New. Satisfaction Guaranteed or your money back. N° de réf. du vendeur 0824708857
Acheter neuf
EUR 269,67
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Expédition nationale : Etats-Unis
Expédition nationale : Etats-Unis
Quantité disponible : 1 disponible(s)