Study on the Impurity Profile and Its Correlation With the Production Process in the Estazolam API and Tablets
The optimized HPLC method demonstrated enhanced sensitivity and separation efficiency. API manufacturers should prioritize purification process optimization for impurities exceeding 0.1% thresholds to ensure drug safety.
Authors
- Mao Wei-qing
- Yuanqing Liu
- Jinlin Nie (ORCID: https://orcid.org/0009-0009-7058-7218)
- Z. Hu
- Dandan Shen
- Jianhua Wang (ORCID: https://orcid.org/0000-0002-0459-7145)
- Lixin Hou
- WU Qun
Institutions
- Chongqing University (CN)
- ZheJiang Institute For Food and Drug Control (CN)
- Jiangsu Province Hospital (CN)
Publication Details
- Journal
- Journal of AOAC International
- Published
- 2025-04-21
- DOI
- https://doi.org/10.1093/jaoacint/qsaf041
- Citations
- 1
- Primary Topic
- Analytical Methods in Pharmaceuticals
- Type
- article
- Field-Weighted Citation Impact
- 0.75