Development and optimization of stability-indicating method of ethinylestradiol, levonorgestrel, and their main impurities using quality by design approach

Author:

da Silva Fernando AntunesORCID,Lourenço Felipe Rebello,Calixto Leandro Augusto

Funder

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference36 articles.

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2. "The Top 300 of 2019". Retrieved December 22, 2018. 〈http://www.clincalc.com〉 (accessed 27 Dec 2019).

3. National Center for Biotechnology Information. PubChem Database. 〈http://www.pubchem.ncbi.nlm.nih.gov〉 (accessed 27 December 2019).

4. ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). Guideline for Impurities in New Drug Products Q3B(R2), 2006. 〈http://www.ema.europa.eu/en/ich-q3b-r2-impurities-new-drug-products〉 (accessed 20 January 2021).

5. ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). Validation of Analytical Procedures: Text and Methodology. Q2 (R1), 2005. 〈http://www.fda.gov/regulatory-information/search-fda-guidance-doccuments/q2r1-validation-analytical-procedures-text-and-methodology-guidance-industry〉 (accessed 20 January 2021).

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Drilling into “Quality by Design” Approach for Analytical Methods;Critical Reviews in Analytical Chemistry;2023-09-04

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