Standard, reference substance, control extraction
National drug standard substances refer to substances used for the physical, chemical and biological testing of national statutory drug standards and traditional Chinese medicines, with determined characteristics or quantities, for calibration equipment, evaluation of measurement methods, assignment or identification of test drugs.
Classification and classification of national drug standard substances
National drug standard substances are divided into two levels.
First-class national drug standard substances: have good quality characteristics, and their characteristic values are measured by definition or other accurate and reliable methods.
Secondary national drug reference substances: with good quality characteristics, their characteristic values are measured using accurate and reliable methods or directly compared with primary reference substances.
National drug reference materials are divided into five categories.
standard Refers to the national drug standard containing a single ingredient or mixed components for the determination of potency, toxicity or content in biological assays, antibiotics or biochemical drugsQuasi-substance. Its biological activity is expressed in international units (IU), units (U), or by weight (g'mg w g).
reference substance It refers to a national drug standard substance that contains a single ingredient, a combination of ingredients or a mixture of components and is used for inspection and instrument calibration of chemicals, antibiotics, some biochemical drugs, medicinal excipients, traditional Chinese medicine materials (including decoction pieces), extracts, proprietary Chinese medicines, and biological products (physical and chemical determination).
control extract It refers to the national drug standard substances prepared by a specific extraction process that contain a variety of main active ingredients or index ingredients and are used for the identification or content determination of traditional Chinese medicine materials (including decoction pieces), extracts, and proprietary Chinese medicines.
Control herbs It refers to the national drug standard substances used for the identification of Chinese herbal medicines (including drinking tablets), extracts, and proprietary Chinese medicines after proper treatment of high-quality Chinese herbal medicines with clear bases and accurate medicinal parts.
reference Refers to the national pharmaceutical standard substances used for qualitative identification of microorganisms (or their products) or quantitative detection of the biological potency and biological activity of certain productsThe titer is expressed in specific active units; or refers to a reference substance prepared from biological reagents, biological materials or specific antisera for the diagnosis of diseases. ----- Source < Chinese Pharmacopoeia "Second Supplement"
