Reference products and standard products refer to the standard substances used in the national drug standards for identification, inspection, content determination, impurity and related substance inspection, which is 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 distinction between reference and standard products:

Reference strains refer to reference substances used for identification, inspection, content determination and calibration of the performance of assay instruments, while reference strains refer to reference substances used for content or titer determination in biological assays, antibiotics or biologic drugs, expressed in titer units (U).

In the literature, the two concepts are often confused, and the reference product is the standard product, which is only one substance and two formulations. The reason for the error may be that some drugs have both reference products and standard products.

For example, when the titer of cefaclor is determined by microbiological method, the standard of cefaclor is used, and the reference is used when the titer is determined by HPLC or UV method. When phenacetin is used as a melting point calibration substance, the melting point standard is used, and the content is determined with a reference. Even if the standard and reference products of the same substance, their specifications, calibration methods and uses may be different.

Mixing of reference and standard products:

The mixing of reference or standard, that is, the use of reference or standard for content determination other than its calibration method, is a frequent but neglected problem in drug testing. Although the content of different calibration methods in the same batch of reference products has a good correlation, it is not exactly the same, and sometimes the difference is very large.

However, due to the following reasons: the instruction manual of reference products provided by the Ministry of Health is not detailed enough, most of the quality requirements and calibration methods of reference products are not available; Lack of knowledge of the proper use of reference or standard products; It is very difficult to find corresponding control products in daily scientific research; In the text of Chinese pharmacopoeia, there is often a problem of mixing reference products, such as the standard or reference products used for content determination are often used for dissolution check, and the content determination method is different from the dissolution analysis method, so it is easy to cause mixing.

The above content is an introduction to the reference product, the reference product refers to the specific substance used for the physical and chemical determination of biological products, prepared by the production unit 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.