Reference products refer to standardized substances used for identification, inspection and content determination, which are prepared, calibrated and supplied by units designated by the drug regulatory department. Those with poor stability may be added without appropriate stabilizers that interfere with the determination of substances. The reference product shall be reviewed and approved by the national drug verification agency, and the reference product shall be consistent with the formula of the product as far as possible. The specification shall not be lower than the quality specification of the product.

The control product is prepared by the manufacturer using the same method as the production process of the product. The reference product should be as consistent as possible with the formula of the product stock, and if the stability is poor, it can be added without appropriate stabilizer that interferes with the determination of substances. The reference product shall be reviewed and approved by the national drug verification agency, and its standard shall not be lower than the quality standard of the product.

Reference products are an integral part of 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.

Reference products are used for identification, inspection, content determination and calibration of the performance of calibration instruments, while standard strains refer to the standard substances used for bioassay, antibiotic or biological drugs content or titer determination. In the literature, the two concepts are often confused, and the reference products are considered to be the standard products, which are only two formulations of one substance. It may be that some drugs have both reference and standard products. Even if the standard and reference products of the same substance, their specifications, calibration methods and uses may be different.

The above content is the introduction of what is the reference product, the reference product is used to check the quality of a special special measuring tool; A standard for measuring the quality of drugs; It is also an indispensable tool for the calibration of testing instruments and methods of material specifications, drug testing, to determine the authenticity of drugs and to control the quality of drugs.