Quantitative method for determination of 3,3‐dimethylallyl bromide genotoxic impurity in Tazarotene drug substance by GC‐MS-Reference-Cited by-同舟云学术

Quantitative method for determination of 3,3‐dimethylallyl bromide genotoxic impurity in Tazarotene drug substance by GC‐MS

Published:2020-07-10 Issue:9 Volume:3 Page:419-427
ISSN:2573-1815
Container-title:SEPARATION SCIENCE PLUS
language:en
Short-container-title:Sep Sci plus

Author:

Rajana Nagaraju¹²^ORCID,Ramana D.V¹,Moses Babu J.²,Basavaiah K.³,Rama Devi Dharamasoth⁴

Affiliation:

1. Technology Development Center, Custom Pharmaceutical Services Dr. Reddy's Laboratories Ltd. Miyapur Hyderabad India

2. Integrated Product Development Organization Dr. Reddy's Laboratories Bachupally Telangana India

3. Department of Inorganic & Analytical Chemistry Andhra University Visakhapatnam Andhra Pradesh India

4. AU College of Pharmaceutical Sciences Andhra University Visakhapatnam Andhra Pradesh India

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sscp.202000009

Reference31 articles.

1. WO 2015/107542 A2 International application published under the patent cooperation treaty (PCT) International Published date July 23 2015.

2. ICH guideline M7 (R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk EMA/CHMP/ICH/83812/2013 August 25 2015.

3. The mechanism of action of alkylating agents;Warwick GP;Cancer Res,1963

4. One-pot synthesis of 6-bromo-4,4-dimethylthiochroman

5. Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation

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