Loss on Drying Using Halogen Moisture Analyzer: An Orthogonal Technique for Monitoring Volatile Content for In-Process Control Samples during Pharmaceutical Manufacturing-Reference-Cited by-同舟云学术

Loss on Drying Using Halogen Moisture Analyzer: An Orthogonal Technique for Monitoring Volatile Content for In-Process Control Samples during Pharmaceutical Manufacturing

Published:2021-02-09 Issue:2 Volume:25 Page:300-307
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Razvi Sayyeda Zeenat A.¹^ORCID,Kamm Isabelle²,Nguyen Tina¹,Pellett Jackson D.¹,Kumar Archana¹^ORCID

Affiliation:

1. Department of Small Molecule Analytical Chemistry, Genentech, Inc., 1 DNA Way, South San Francisco, California 94080, United States

2. PTMMA Department, F. Hoffmann-La Roche AG, Grenzacherstrasse 124, 4070 Basel, Switzerland

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.0c00512

Reference14 articles.

1. FDA. Food and Drug Administration Guidance for Industry PAT- A framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. 2004.

2. ICH. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Technical and regulatory considerations for pharmaceutical product lifecycle management. Q12, Step 4 ed. ICH, 2019; p 31.

3. ICH. ICH Harmonized Tripartite Guideline: Pharmaceutical development. Q8(R2); ICH, 2009; p 28.

4. Analytical procedures for quality control of pharmaceuticals in terms of residual solvents content: Challenges and recent developments

5. Critical assessment of the performance of electronic moisture analyzers for small amounts of environmental samples and biological reference materials

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