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On December 25, Shandong Provincial Drug Administration issued the 9th Issue of Drug Quality Testing Notice 2020 (hereinafter referred to as the "Notice").
circular said that in order to strengthen drug quality supervision and ensure the safety of public drug use, according to the annual sampling work plan of the provincial drug regulatory bureau, the provincial bureau of drug production, operation and use units carried out drug quality spot checks and inspections, after verification and confirmation, marked 11 production enterprises (preparation units) a total of 7 varieties of 11 batches of drugs, after sampling does not meet the standards.
It is worth noting that in these 7 varieties of drugs, there are 3 kinds of preparations, respectively, Malay acid ammonia chlorpyrine tablets, libawelin tablets, snake bile Sichuan bay liquid;
For the above non-conforming drugs, the relevant drug regulatory departments have taken control measures such as seizure, seizure, suspension of sales and product recall of non-compliant products, and in accordance with relevant laws and regulations on the relevant production enterprises (preparation units), sampling units in accordance with the law serious investigation and punishment, investigation and punishment can be called upon the Shandong Provincial Drug Administration or the relevant municipal market supervision authority website.
At the same time, the Shandong Provincial Drug Administration requires that the relevant drug regulatory departments strengthen supervision over non-compliant products and corresponding production and operation enterprises and units, urge them to identify the causes of the problems, formulate and implement corrective measures, and effectively eliminate hidden risks.
: does not meet the provisions of the project small knowledge I, characteristics under the record of appearance, odor, taste, solubility and physical constants, to a certain extent, reflect the quality characteristics of drugs.
chinese medicine drink tablets do not meet the requirements, may involve the following situations: the herbal medicine species deviation, the concoction process is defective, improper storage and so on.
II, the relevant substances refers to drugs in accordance with the established process of production and normal storage process may contain or produce and need to control impurities, is to reflect the purity of drugs, to ensure the safety of one of the important indicators. The substances in
drugs are mainly impurities brought in during preparation, or impurities produced by the degradation of the drug itself in storage or transportation, under the influence of external conditions (e.g. daylight, air, temperature, humidity, etc.) or microorganisms.
the substance may have an impact on the safety of the drug.
, the purpose of total ash determination is to test the purity of Chinese medicine.
, content determination refers to the use of prescribed test methods to determine the content of active ingredients in raw materials and preparations, generally can be used chemical, instrument or biometric methods.
content determination is related to the efficacy of the drug.
, identification is mainly used to identify and study the authenticity, safety and effectiveness of drugs.
according to the characteristics of different drugs, including empirical identification, micro-identification and physical and chemical identification, physical and chemical identification includes physical, chemical, spectral, chromatography and other identification methods.
, the time limit for disintegration refers to the limit of the time it takes for a solid preparation to inspect all disintegration or fragmentation and pass through a screen in a prescribed medium by a specified method.
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