A standard substance is a standard substance, as a measure, used in medicine, is the standard content in the determination of content. Standards also include stoichiometric standards, metallurgical standards and drug testing standards. The China Institute for the Control of Pharmaceutical Products has provided 2,930 kinds of national standard substances, including 650 kinds of traditional Chinese medicine chemical reference substances and 730 kinds of reference medicinal materials.
Let's talk about its use instructions. Most of the standard products (reference products) provided by China Pharmaceutical Product Inspection and Control have no use instructions or expiry date. Most of them follow the management mode that new batch numbers appear and old batch numbers stop automatically.
After opening must correct management, some enterprises to kaifeng after standard (reference) management did not make any file regulation, still with unopened standard (reference substance) together to continue to use, not to make any logo on the package, don't see whether from the appearance are over, when kaifeng kaifeng, containing a small amount of related information.
And then there's the classification, the biological reference substances fall into two categories. The first is the national biological standard, refers to the standard substance calibrated with international standards, or developed by our country (there is no international biological standard) for quantitative determination of the potency or toxicity of a product, its biological activity in international units (IU) or in units (U). The second is the national biological reference, refers to the calibrated with international reference, or our own development (there is no international reference) for microbial (or its products) qualitative identification or disease diagnosis of biological reagents, biological materials or specific antiserum; Or refers to a reference substance used for quantitative determination of the biotiter of some products, such as a reference substance used for determination of the titer of a live measles vaccine or a toxoidflocculent unit, expressed in specific units of activity, not in (IU).