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Specifics of herbal drugs quality testing with the examples of typical criticism of laboratory testing of those

Authors :
N. P. Antonova
S. S. Prokhvatilova
E. P. Shefer
A. M. Kalinin
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.

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.

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