Pharmaceutical analysis for small molecules / edited by Behnam Davani, Principal Scientific Liaison, General Chapters, Science Division, U.S. Pharmacopeia.
Material type: TextPublisher: Hoboken, NJ : Wiley, 2017Edition: First editionDescription: 1 online resourceContent type:- text
- computer
- online resource
- 9781523114870
- 1523114878
- 615.1/9 23
- RS420
- QV 25
Includes bibliographical references and index.
Drug approval process and regulatory requirements / Roger Dabbah -- Pharmacopeias and compendial approval process / Roger Dabbah -- Common methods in pharmaceutical analysis / Behnam Davani -- Common calculations / Behnam Davani -- Analytical method validation, verification, transfer / Behnam Davani -- Specifications / Ernest Parente -- Impurities / Behnam Davani -- Good documentation practices / Afsaneh Motamed Khorasani -- Management of analytical laboratories / Roger Dabbah -- Analytical instrument qualifications / Shaligram Rane and Rustom Mody.
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