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Specifics of herbal drugs quality testing with the examples of typical criticism of laboratory testing of those
- Source :
- Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 3, Pp 18-22 (2018)
- Publication Year :
- 2018
- Publisher :
- Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), 2018.
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Abstract
- The paper describes the basic quality parameters of the starting materials of herbal origin and herbal drugs, taking into account the requirements of State Pharmacopeia XI and draft general chapters of State Pharmacopeia XIII. It enlists the main terms and definitions, and the requirements to presentation of the quality parameters. It provides the examples of typical criticism of the normative documents on herbal drugs in terms of various quality parameters, including “Appearance”, “Identification tests”, “Chromatography”, “Degree of fineness”, “Assay”. The criticism has been leveled at the quality of both draft normative documents and the samples submitted for testing. The survey conducted allows for explaining the expert requirements to the quality of samples and the presentation of several test methods.
- Subjects :
- лекарственное растительное сырье
лекарственные растительные препараты
показатели качества лекарственного растительного сырья
экспертиза качества
типичные ошибки заявителей
starting materials of herbal origin
herbal drugs
quality parameters of starting materials of herbal origin
quality testing
applicants’ common mistakes
Medicine (General)
R5-920
Subjects
Details
- Language :
- Russian
- ISSN :
- 30343062 and 30343453
- Issue :
- 3
- Database :
- Directory of Open Access Journals
- Journal :
- Регуляторные исследования и экспертиза лекарственных средств
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.8e50d111d001460795dec9938f51bbfb
- Document Type :
- article