Standard products and reference products refer to the standard substances used for identification, inspection and content determination, which are prepared, calibrated and supplied by the units designated by the drug regulatory department under The State Council. Reference products and standard products now many people are easy to confuse, often for a while can not clearly distinguish the relationship between the two. So how do you tell the difference? The following is a small edition of Bolinda to introduce the difference between control products and standard products.

Standard product: In fact, it is a standard substance used for biological testing, or the content of biological drugs, expressed by the titer unit "u". It refers to the standard substances used for identification, inspection and content determination, which are prepared, calibrated and supplied by the units designated by the supervisory and administrative department under The State Council. A standard strain is a standard substance used for the determination of content or titer in biological or biochemical drugs, and is calibrated by an international standard; Unless otherwise specified, reference products should be used after drying.

Reference product: refers to a standard substance used for identification, inspection and content determination, prepared, calibrated and supplied by a unit designated by the drug regulatory department under The State Council.

The national drug control and standard series are mainly used to identify the content detection, impurity and related substance inspection in drug standards, and it is an important component of national drug standards. The national drug substance standard is the important basis of the national drug standard, a measure used to check the quality of drugs, is the fundamental measurement of drug quality. It is to revise the material standards of testing instruments and methods; It can determine the authenticity and quality of drugs.

Note:

1. It is extremely difficult to find corresponding reference substances in daily scientific research;

2. The control instruction manual provided by the Health and Health Commission is not detailed enough, and most of them do not have the quality requirements and calibration methods of the reference products;

3. Lack of knowledge of the proper use of reference substances or reference substances;

4. In the Chinese pharmacopoeia text, there is often a problem of mixing reference substances. For example, the standard substances or reference substances 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 the introduction of the difference between the reference product and the standard product, in fact, the reference product and the standard product are two completely different concepts, but they have a common denominator, that is, they belong to the national standard material.