Review on Implementation of Multivariate Approach for Forced Degradation Study and Impurity Profiling with Regulatory Considerations

Author:

Patel Mital N.ORCID,Kothari Charmy S.ORCID

Publisher

Springer Science and Business Media LLC

Subject

Organic Chemistry,Clinical Biochemistry,Biochemistry,Analytical Chemistry

Reference88 articles.

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3. Alsante KM, Martin L, Baertschi SW (2003) A stress testing benchmarking study. Pharm Technol 27:60–72

4. Singh S, Bakshi M (2000) Guidance on conduct of stress tests to determine inherent stability of drugs. Pharm Technol 4:1–14. ( http://www.pharmaportal.com )

5. ICH H tripartite guideline (2005) Validation of analytical procedures: methodology Q2(R1). http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html . Accessed 18 Dec 2016

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