Applications of Gage Reproducibility & Repeatability (GRR): Understanding and Quantifying the Effect of Variations from Different Sources on a Robust Process Development-Reference-Cited by-同舟云学术

Applications of Gage Reproducibility & Repeatability (GRR): Understanding and Quantifying the Effect of Variations from Different Sources on a Robust Process Development

Published:2014-12-08 Issue:12 Volume:18 Page:1614-1621
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Deshpande Amol A.¹,Ramya Ayyalasomayajula¹,Vishweshwar Vavilala¹,Deshpande Girish R.¹,Roy Amrendra Kumar²

Affiliation:

1. Custom Pharmaceutical Services, Dr. Reddy’s Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad, Telangana State 500049, India

2. Process Engineering Excellence, CTO-III, Dr. Reddy’s Laboratories Ltd., Plot 116, 126C & Survey Number 157, S.V. Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Medak District, Telangana State 502325, India

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op5002935

Reference29 articles.

1. Acetic anhydride-promoted one-pot condensation of 2,4-thiazolidinedione with bisulfite adducts of aldehydes

2. Controlling the Exothermicity of O-Arylation by Evaporative Cooling during the Process Development of Fluoxetine Hydrochloride

3. Applying QbD Principles To Develop a Generic UHPLC Method Which Facilitates Continual Improvement and Innovation Throughout the Product Lifecycle for a Commercial API

4. Application of the QbD Principles in the Development of the Casopitant Mesylate Manufacturing Process. Process Research Studies for the Definition of the Control Strategy of some Drug Substance-CQAs for Stages 2a, 2b, and 2c

5. Development of a Dynamic Kinetic Resolution for the Isolation of an Intermediate in the Synthesis of Casopitant Mesylate: Application of QbD Principles in the Definition of the Parameter Ranges, Issues in the Scale-Up and Mitigation Strategies

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