The requirements for methods of analysis and the quality of pharmacopoeia reference standards for herbal medicines
According to current trends in the development of pharmacopoeial analysis, related to harmonization and standardization of the requirements for drug quality and drug standardization, newly developed regulatory documents for reference standards (RS) must contain a number of methods for RS quality assessment based on modern physical and chemical analytical methods. These methods require appropriate reference standards, which assure the accuracy and the specificity of a research. The article describes the characteristics of pharmacopoeia reference standards for herbal medicines and their certification requirements, specifically for identification, purity test and assay. To ensure the quality, efficacy and safety of herbal medicines used in medical practic continuous standardization of raw herbal materials and a related preparation is required.