{"title":"眼科药物中的机械夹杂物","authors":"O. V. Gunar, A. V. Dorenskaya, N. G. Sakhno","doi":"10.1007/s11094-024-03109-x","DOIUrl":null,"url":null,"abstract":"<p>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.</p>","PeriodicalId":19990,"journal":{"name":"Pharmaceutical Chemistry Journal","volume":"24 1","pages":""},"PeriodicalIF":0.8000,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Mechanical Inclusions in Ophthalmic Drugs\",\"authors\":\"O. V. Gunar, A. V. Dorenskaya, N. G. Sakhno\",\"doi\":\"10.1007/s11094-024-03109-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>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.</p>\",\"PeriodicalId\":19990,\"journal\":{\"name\":\"Pharmaceutical Chemistry Journal\",\"volume\":\"24 1\",\"pages\":\"\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2024-04-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceutical Chemistry Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11094-024-03109-x\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Chemistry Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11094-024-03109-x","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
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.
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.