In order to have a common standard to ensure the quality of products, reference products and standards have become part of people's lives. So what are the standards and the controls? What's the difference between a standard and a reference? The following is a small edition of Bolinda to introduce you.

What are standard and reference products:

Reference product and standard product are two different concepts, which have been clearly defined in the Chinese Pharmacopoeia: reference product refers to the standard substance used for identification, inspection, content determination and calibration of the performance of the calibration instrument. Standard strains are reference substances used in bioassay, antibiotic or biologic drug content or titer determination, expressed in titer unit (U).

The difference between standard and control products:

1, usually used to calibrate the performance of the calibration instrument, inspection, identification and content determination of the reference material is the reference product, and used for biological drugs in the content determination, identification of biological and antibiotic reference material is the standard product.

People often confuse, feel that the reference product is the standard product, is the same substance of two different formulations, which is easy to make mistakes, the reason for the error can be that some drugs have reference products also have standard products, even if the same substance of the reference and standard products, calibration methods, specifications and uses may be different.

2, the reference product is a specific substance prepared by the production unit using the same method as the production process of the product, which is used for the determination of physical and chemical aspects of biological products. A standard substance is a standard substance used for the determination of content in antibiotics, bioassays and biochemical drugs, and is calibrated to an international standard. The control product must ensure that it is consistent with the standard formula of the product.

The lack of a suitable stabilizer for the measured interfering substance can be added to compensate for some of the poor stability of the control substance. The reference product is reviewed and approved by the national drug verification agency, and its standard cannot be lower than the quality standard of the product, otherwise it cannot correctly play the role of the reference product.

The above content is what is the standard and the reference product, the difference between the standard and the reference product, in many cases, people will mix the reference product and the standard product in many cases, that is, the reference product or the standard product is not the content determination of its calibration method, which is often a problem in drug testing, if not paid attention to, There could be a lot of damage.