Simultaneous Determination of Genotoxic Impurities in Fudosteine Drugs by GC–MS

Author:

Gooty Amarnatha Reddy,Katreddi Hussain Reddy,S Raghavender Reddy,Hunnur Raveendra K.,Sharma Hemant Kumar,Masani Narendra Kumar

Publisher

Oxford University Press (OUP)

Subject

General Medicine,Analytical Chemistry

Reference12 articles.

1. Inhibition of endotoxin- and antigen-induced airway inflammation by fudosteine, a mucoactive agent

2. Effect of fudosteine, a cysteine derivative, on airway hyperresponsiveness, inflammation, and remodeling in a murine model of asthma

3. European Medicines Evaluation Agency. Guideline on the limits of genotoxic impurities, CPMP/SWP/5199/02 , Committee for Medicinal Products for Human Use (CHMP), London, June 28, (2006).

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

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

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