Reference substance refers to the standard substance used for identification, inspection, content determination and calibration of the performance of the verification instrument.
The standard product refers to the standard substance used in the bioassay, the determination of the content or potency in antibiotics or biological drugs, and is expressed in potency units (U).
Still do not feel clear, is the standard used only for biology? Is it only called the reference in the chemical aspect? What are the requirements for the standard? What are the requirements for the reference?
The National Drug Standards and Reference Standards refer to the standard substances used for identification, inspection, content determination, impurity and related substance inspection in the National Drug Standards, which are an integral part of the National Drug Standards. The national drug standard substance is the material basis of the national drug standard. It is a special special measuring tool used to check the quality of drugs; it is a benchmark for measuring the quality of drugs; it is also a substance standard used as a calibration test instrument and method; in drug inspection , It is a comparison to determine the authenticity of the medicines, is an indispensable tool to control the quality of medicines.
At present, the China National Institute for the Control of Pharmaceutical and Biological Products has been able to provide 1242 kinds of national standard substances, including 288 kinds of Chinese medicine chemical reference materials and 400 kinds of reference medicinal materials, both of which account for more than half of the total. The preparation and calibration of standard materials for identification, inspection of content or potency determination shall comply with the requirements of "National Standard Material Preparation and Calibration Procedures for Biological Products", and shall be distributed by the agency designated by the Drug Administration of the State Council. Enterprise work standards or reference products must be standardized by national standards or reference products before they can be used.
The reference substance refers to a specific substance used for the determination of the physical and chemical aspects of biological products. It is prepared by the production unit using the same method as the product production process. The reference substance should be as consistent as possible with the product's original liquid formula. If the stability is poor, a suitable stabilizer containing no interfering substances may be added. The reference product shall be reviewed and approved by the national drug inspection agency, and its standard shall not be lower than the quality standard of the product.
(3) Standard products and reference products: refer to the standard materials used for identification, inspection, and content determination, which are prepared, calibrated, and supplied by the unit designated by the drug regulatory department of the State Council. Standards refer to standard substances used in bioassays, antibiotics or biochemical drugs for determination of content or potency. An international standard is used for calibration. Unless otherwise specified, reference products are calculated after drying and used. Both the standard product and the reference product are accompanied by the instruction manual, quality requirements, expiration date and loading volume.
1 Definition
Biological standard substance refers to a biological standard or biological reference substance used for the determination of the titer, activity or content of biological products or for the identification and inspection of their characteristics.
2 Types of reference materials The reference materials for biological products are divided into two categories.
National biological standard refers to a standard substance that is calibrated with an international standard or developed by China (one without an international biological standard) for quantitative determination of potency or toxicity of a product. Its biological activity is measured in international units (IU) Or expressed in units (U).
National biological reference refers to a biological reagent, biological material or specific antiserum that is calibrated with an international reference or developed by China (one without an international reference) for qualitative identification of microorganisms (or their products) or disease diagnosis ; Or refers to a reference substance used for quantitative detection of the biological potency of certain products, such as the reference product used for the determination of the measles live vaccine titer or toxoid flocculent unit, the potency of which is expressed in specific active units, not (IU ) Means.
1 Unclear concept of reference substance and standard substance Reference substance and standard substance are two different concepts. The Chinese Pharmacopoeia has a clear definition in the common law: Reference substance refers to the standard substance used for identification, inspection, content determination and calibration of the performance of the instrument The standard product refers to the standard substance used in the bioassay, antibiotic or biological drug content or potency determination, expressed in potency units (U). In the literature, the two concepts are often confused, and the reference substance is a standard substance, which is a substance and two kinds of formulations [1,2]. The cause of the error may be that some drugs have both a reference substance and a standard substance. For example, when the cefaclor titer is determined by the microbiological method, the cefaclor standard is used, when the HPLC or UV method is used, the control is used; when phenacetin is used as a melting point calibration substance, the melting point standard is used, When determining the content, use the reference substance. Even for standard and reference products of the same substance, their specifications, calibration methods, and uses may be different.
2 Mixed use of reference or standard
The mixed use of reference or standard products, that is, the use of reference or standard products for content determination that is not their calibration method, is a problem that often occurs in drug testing but has not attracted attention [3]. Although the contents of different calibration methods of the same batch of reference substances are well correlated, they are not exactly the same, and sometimes they will be very different. For example, the cefuroxime axetil reference material provided by the British Glaxo company, HPLC calibration is 96.9%, for content determination; UV is 98.8%, for dissolution determination. Although the Chinese Pharmacopoeia stipulates clearly that the reference products issued by the Ministry of Health should only be used for the analysis methods specified in the text. But due to:
(1) The instruction manual of the reference product provided by the Ministry of Health is not detailed enough, and most of them do not have the quality requirement and calibration method of reference;
(2) Lack of understanding of the correct use of reference or standard products;
(3) It is extremely difficult to find the corresponding reference in daily scientific research;
(4) The text of the Chinese Pharmacopoeia often has the problem of mixed use of reference substances. For example, the standard or reference substance used for content determination is often used for dissolution testing, and the content determination method is different from the dissolution analysis method. .
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