A Direct Standard Headspace Method for the Determination of Chloroacetic Acid and Dichloroacetic Acid in Armodafinil Drug Substance by GC-MS-Reference-Cited by-同舟云学术

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A Direct Standard Headspace Method for the Determination of Chloroacetic Acid and Dichloroacetic Acid in Armodafinil Drug Substance by GC-MS

Published:2022-01-02 Issue:1 Volume:12 Page:134-146
ISSN:2229-7928
Container-title:Analytical Chemistry Letters
language:en
Short-container-title:Analytical Chemistry Letters

Author:

Venkata Ramana Reddy Junuthula¹²,Surendra Babu Manabolu Surya¹,Narendra Kumar Masani²,Sharma Hemant Kumar²

Affiliation:

1. Department of Chemistry, School of Science, GITAM Deemed to be University-Hyderabad Campus, Hyderabad-502329, Telangana, India

2. Aurobindo Pharma Limited Research Centre-II, Survey No: 71&72, Indrakaran Village, Kandi Mandal, Sangareddy-502329, Telangana, India

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/22297928.2021.2017797

Reference18 articles.

1. European Medicines Evaluation Agency. (2006). Guideline on the limits of genotoxic impurities. CPMP/SWP/5199/0. Committee for Medicinal Products for Human Use (CHMP) London, June 28.

2. Genotoxic and carcinogenic impurities in drug substances and Products. (2008). Recommended Approaches, FDA Center for Drug Evaluation and Research, Guidance for Industry (Draft) December 03.

3. ICH guideline: Impurities in New drug substances Q3A, (R2). (2006). ICH guideline. Impurities in new drug products Q3B, (R2), International Conference on Harmonisation.

4. Differential patterns of regional c-Fos induction in the rat brain by amphetamine and the novel wakefulness-promoting agent modafinil

5. Armodafinil and Modafinil Have Substantially Different Pharmacokinetic Profiles Despite Having the Same Terminal Half-Lives

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