Application of quality by design concept to develop a dual gradient elution stability-indicating method for cloxacillin forced degradation studies using combined mixture-process variable models

Author:

Zhang Xia,Hu Changqin

Funder

National Key New Drug R&D Program Foundation of China

Publisher

Elsevier BV

Subject

Organic Chemistry,General Medicine,Biochemistry,Analytical Chemistry

Reference38 articles.

1. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline, Stability Testing of New Drug Substances and Products Q1A(R2) (2003).

2. Aspects of the design space in high pressure liquid chromatography method development;Molnár;J. Chromatogr. A,2010

3. Improvement of a stability-indicating method by quality-by-design versus quality-by-testing: a case of a learning process;Hubert;J. Pharm. Biomed. Anal.,2014

4. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guideline, Pharmaceutical Development Q8 (R2) (2009).

5. Analytical quality by design: a tool for regulatory flexibility and robust analytics;Peraman;Int. J. Anal. Chem.,2015

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