On-line near infrared spectroscopy as a Process Analytical Technology (PAT) tool to control an industrial seeded API crystallization-Reference-Cited by-同舟云学术

On-line near infrared spectroscopy as a Process Analytical Technology (PAT) tool to control an industrial seeded API crystallization

Published:2013-09 Issue: Volume:83 Page:194-201
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Schaefer C.,Lecomte C.,Clicq D.,Merschaert A.,Norrant E.,Fotiadu F.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference32 articles.

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2. Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance;United States Food and Drug Administration (FDA),2004

3. International Conference on Harmonization (ICH),2009

4. International Conference on Harmonization (ICH),2005

5. International Conference on Harmonization (ICH),2008

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