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Development of a Method for Determination of Related Impurities in GML-3 Drug Substance: A New Compound with Anxiolytic Properties
Pharmaceutical Chemistry Journal ( IF 0.9 ) Pub Date : 2020-11-25 , DOI: 10.1007/s11094-020-02284-x L. N. Grushevskaya , M. S. Sergeeva , L. M. Gaevaya , M. E. Dudenkova , E. D. Denisenko , N. I. Avdyunina , S. V. Minaev , G. V. Mokrov
中文翻译:
测定GML-3药物中相关杂质的方法的开发:一种具有抗焦虑特性的新化合物
更新日期:2020-11-25
Pharmaceutical Chemistry Journal ( IF 0.9 ) Pub Date : 2020-11-25 , DOI: 10.1007/s11094-020-02284-x L. N. Grushevskaya , M. S. Sergeeva , L. M. Gaevaya , M. E. Dudenkova , E. D. Denisenko , N. I. Avdyunina , S. V. Minaev , G. V. Mokrov
A method for determination of related impurities in the new anxiolytic drug substance GML-3 was developed. HPLC and TLC techniques that could identify starting materials and synthetic intermediates and quantify them and unidentified impurities with contents of 0.05% and less in the drug substance were developed. The proposed techniques could be used further for quality control of GML-3 drug substance.
中文翻译:
测定GML-3药物中相关杂质的方法的开发:一种具有抗焦虑特性的新化合物
建立了一种新的抗焦虑药物GML-3中相关杂质的测定方法。开发了可以鉴定原料和合成中间体并对其进行定量的HPLC和TLC技术,并开发了原料药中含量不超过0.05%的未鉴定杂质。所提出的技术可以进一步用于GML-3原料药的质量控制。