Standard products and reference products refer to the standard substances used in the national drug standards for identification, inspection, content determination, inspection of impurities and related substances, and 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.

Although there is a certain difference between standard products and control products, the phenomenon of mixing standard products or control products is common, which brings certain troubles. So why is there a mixture of standard and control products? Below, Bolinda Xiaobian to introduce you to the reasons.

Why is there mixed use of standard or control products?

1, the Ministry of Health provided the reference product instruction manual is not detailed enough, the very key part did not make a detailed introduction, most of the quality requirements and calibration methods of the reference product, which makes people in the use of standard products and reference products when there are mistakes.

2, users of the standard or reference products, or even the correct use of both of the knowledge is quite lack, is the so-called to use a thing must have a full understanding of it, so in the case of not understanding the error is reasonable.

3, it is extremely difficult to find the corresponding reference products in daily scientific research, so researchers have to replace the reference products with standard products, and over time we confuse the difference between the two.

4, the Chinese pharmacopoeia text also often exists the problem of mixing of reference products, such as the standard product or reference product used for content determination is often used for dissolution inspection, and the content determination method and dissolution analysis method are different, so it is easy to cause mixing.

The above content is to explain why there is a mixed use of reference or reference products, that is, the use of reference or reference products for content determination that is not its calibration method, is a problem that often appears in drug testing but has not been paid attention to. 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.