眼科药物中的机械夹杂物

IF 0.8 4区医学 Q4 CHEMISTRY, MEDICINAL

Pharmaceutical Chemistry Journal Pub Date : 2024-04-16 DOI:10.1007/s11094-024-03109-x

O. V. Gunar, A. V. Dorenskaya, N. G. Sakhno

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引用次数: 0

摘要

介绍了不同剂型的眼科药物在质量指标 "特定污染--亚可见颗粒 "方面的分析结果。讨论了适用于眼科药品质量这一参数的可能分析方法和监管要求。介绍了眼科剂型中亚可见微粒物质的分析结果（40 个样品）。说明有必要对滴眼剂中的亚可见微粒物质采用与主要药典相一致的现代标准化方法。

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Mechanical Inclusions in Ophthalmic Drugs

Analytical results for different dosage forms of ophthalmic drugs for the quality indicator “Particular contamination – subvisible particles” are presented. The possible analytical methods and regulatory requirements applicable to the quality of ophthalmic drugs for this parameter are discussed. Analytical results for subvisible particulate matter in ophthalmic dosage forms (40 samples) are presented. The need to introduce modern standardization of subvisible particulate matter in eye drops that is harmonized with leading pharmacopoeias is demonstrated.

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来源期刊

Pharmaceutical Chemistry Journal CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

1.30

自引率

22.20%

发文量

226

审稿时长

3-8 weeks

期刊介绍： Pharmaceutical Chemistry Journal is a monthly publication devoted to scientific and technical research on the creation of new drugs and the improvement of manufacturing technology of drugs and intermediates. International contributors cover the entire spectrum of new drug research, including: methods of synthesis; results of pharmacological, toxicological, and biochemical studies; investigation of structure - activity relationships in prediction of new compounds; methods and technical facilities used; and problems associated with the development of ecologically safe and economically feasible methods of industrial production. In addition, analytical reviews of the international literature in the field provide coverage of the most recent developments around the world. Pharmaceutical Chemistry Journal is a translation of the Russian journal Khimiko-Farmatsevticheskii Zhurnal. The Russian Volume Year is published in English from April. All articles are peer-reviewed.