National drug standards and reference strains refer to the standard substances used in the national drug standards for identification, inspection, content determination, inspection of impurities and related substances, which are an integral part of the national drug standards. The national drug standard material is the material basis of the national drug standard, which is a special measuring tool used to check the quality of drugs. It is the benchmark for measuring drug quality; It is also used as a material standard for calibration of test instruments and methods; In drug testing, it is a control to determine the authenticity of drugs, is an essential tool to control the quality of drugs. The following is a small edition of Bolinda to introduce the importance of standard products and reference products for drug identification, inspection and content determination.

The importance of standard and reference products for drug identification, inspection and content determination:

1, the reference product (standard product) used by the Institute has been issued and provided (refer to the Appendix X ⅤG of the second part of the 2000 edition of the Chinese Pharmacopoeia), and the use of the same method, should use the current batch number of the reference product (standard product) provided by the institute, and provide its label and instruction manual, indicating that the batch number should not be used from other sources.

If the use method is different from the manual use method (such as qualitative reference product for quantitative use, titer determination standard product for physical and chemical determination, UV or volumetric reference product for chromatographic determination, etc.), the appropriate method should be re-calibrated, and the calibration method and data should be provided; If the reference product for chromatographic content determination is used as UV method or volumetric method, and the quantitative reference product is used as qualitative, etc., it can be directly applied without re-calibration.

2. When applying for clinical studies, if the Institute does not have any supply, in order not to affect the registration progress, you can contact the Institute for preparation and calibration in advance, and provide calibration reports, labels (which should indicate titer or content, batch number, use validity period) and instructions for use when applying; It can also cooperate with the provincial calibration, and provide research data of standard or reference products when declaring, "explaining its source, physical and chemical constants, purity, content and determination methods and data".

When calibration is difficult, the reference product (standard product) issued by foreign drug administration authorities or pharmacopoeia committee or the working reference product (standard product) of foreign pharmaceutical enterprises can be used for standard formulation and other basic research, but its label (should be marked with its content) and instruction manual should be provided to ensure the traceability of its quantitative value; Reference products (standard products) provided by foreign reagent companies can also be used, but the reagent company should provide the test report of the batch of reference products (standard products) (used for content determination, there should be determined content data), such as high-purity reagents, provided foreign reagent company test report (used for content determination, there should be determined content data), can also be used. It should be able to ensure the traceability of its quantitative value, but the applicant should promptly contact the CCI about the calibration of the reference product (standard product), and complete this work during the clinical study.

3, directly declare the production varieties, if the CCI does not have the supply, you can refer to the requirements in 2, and provide the corresponding research data, but the applicant should contact the CCI during the standard trial period and complete the calibration matters.

The above content is the introduction of the importance of standard products and reference products for drug identification, inspection and content determination. At present, the China Institute for Drug and Biological Products Inspection has been able to provide 1242 kinds of national standard substances, including 288 kinds of Chinese medicine chemical reference products and 400 kinds of control herbs, which account for more than half of the total. National standard products and biological reference products refer to the reference substances used for identification and inspection of content or titer determination, the preparation and calibration of which shall comply with the requirements of the "Preparation and Calibration Procedures of National Standard Substances for Biological Products", and shall be distributed by the institution designated by the drug regulatory department under The State Council.