Thermally induced solid-state transformation of cimetidine. A multi-spectroscopic/chemometrics determination of the kinetics of the process and structural elucidation of one of the products as a stable N3-enamino tautomer

Author:

Calvo Natalia L.,Simonetti Sebastian O.,Maggio Rubén M.,Kaufman Teodoro S.

Publisher

Elsevier BV

Subject

Spectroscopy,Environmental Chemistry,Biochemistry,Analytical Chemistry

Reference62 articles.

1. Forced degradation and impurity profiling: recent trends in analytical perspectives;Jain;J. Pharm. Biomed. Anal.,2013

2. ICH Harmonized Guideline: Impurities in New Drug Substances Q3A (R2), ICH Steering Committee, Geneva, Switzerland, 2006.

3. ICH Harmonized Guideline: Impurities in New Drug Products Q3B (R2), ICH Steering Committee, Geneva, Switzerland, 2006.

4. The United States Pharmacopeia, USP36-NF31, Impurities in Drug Substances and Drug Products, U.S. Pharmacopeial Convention Inc., Rockville, MD, USA, 2013 (Chapter 1086).

5. Evaluating impurities in drugs (Part I of III);Wadekar;Pharm. Technol.,2012

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