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What is the difference between standard and control samples?
A standard substance, also known as a standard item, serves as a measurement standard. If used in the field of medicine, it is the standard content in content determination. Standards include chemical metrology standards, metallurgical standards, and drug testing standards. Using biochemical methods for determination, there are a total of 15 national standards, including lincomycin, neomycin, spectinomycin, tylosin, streptomycin, kanamycin, chorionic gonadotropin, salinase, bacitracin zinc, guitarin, ampicillin, erythromycin, synthetic oxytocin, gentamicin, and naringin G.
Reference substance refers to a standard substance used for identification, inspection, content determination, and calibration of instrument performance. Chemical methods are used for determination, which are commonly referred to as reference standards in general instruments. There are 107 types of standards specified by the state, including dexamethasone, oxytetracycline, amoxicillin, and so on.
But standard and reference standards are two different concepts. The Chinese Pharmacopoeia has a clear definition: standard standards refer to standard substances used for biological identification, antibiotic or biopharmaceutical content or potency determination, expressed in potency units (U), while reference standards refer to standard substances used for identification, inspection, content determination, and calibration of instrument performance. The literature often confuses these two concepts, believing that a standard substance is a reference substance, which is a different term for the same substance. The reason for this misunderstanding may be that some drugs have both standard and reference substances. For example, when using phenacetin as a melting point calibration substance, a melting point standard is used, and when determining the content, a reference substance is used; When using microbiological methods to determine the potency of cefaclor, the cefaclor standard is used, while when using HPLC or UV methods, the reference substance is used.
Mixing the two:
The mixed use of reference or standard substances, which refers to the use of reference or standard substances for content determination that is not the calibration method, is a common but overlooked issue in drug testing. Although there is a good correlation between the contents of different calibration methods for the same batch of reference materials, they are not exactly the same, and sometimes the differences can be significant. The reference standard for cefuroxime axetil provided by Glaxo in the UK, calibrated to 96.9% by HPLC, is used for content determination; UV is 98.8% for dissolution determination. Although the Chinese Pharmacopoeia explicitly states that the reference standards issued by the Ministry of Health are only used for the analytical methods specified in the main text. But due to:
(1) The instructions provided by the Ministry of Health for the use of reference materials are not detailed enough, and most of them do not have quality requirements and calibration methods for reference materials;
(2) Lack of understanding of the correct use of reference or standard materials;
(3) It is extremely difficult to find corresponding reference materials in daily scientific research;
(4) In the main text of the Chinese Pharmacopoeia, there is often a problem of mixing reference standards. As usual, the standard or reference standards used for content determination are used for dissolution testing, and the methods for content determination and dissolution analysis are different, which can easily lead to mixing.
Shanghai Hengyuan Biotechnology Co., Ltd. was established in December 2010. It integrates research and development, production, and sales, with the core of scientific research reagent production and diagnostic reagent raw material supply production. It is committed to providing high-quality biological products to customers from universities, research institutions, diagnostic reagent manufacturers, and biopharmaceutical companies around the world. Hengyuan Biotechnology currently has over 500000 genetic products of various species; More than 200000 types of recombinant proteins; There are over 30000 types of polyclonal antibodies from dozens of species and hundreds of high-quality monoclonal antibodies. Hengyuan brand has independently developed ELISA kits, which now cover more than 20 species and thousands of products, involving more than ten research fields such as tumors, hormones, autoimmune diseases, cardiovascular diseases, metabolism, etc.
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