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[ Focus on Chemical Machinery and Equipment Network ] Drugs are closely related to life.
Ensuring the quality of drugs and the safety of public use of drugs is not only related to the health and safety of patients, but also helps to further improve drug quality management throughout the life cycle.
It is understood that there are often impurities in drugs that have no therapeutic effect or affect the efficacy and stability of the drug, and these impurities may even cause harm to human health.
Therefore, in order to ensure drug safety, companies need to conduct drug impurity analysis and control the impurity content in the drug.
Chemical machinery and equipment network hotspots pay attention to chemical machinery and equipmentEnsuring the quality of drugs and the safety of public use of drugs is not only related to the health and safety of patients, but also helps to further improve drug quality management throughout the life cycle.
It is understood that there are often impurities in drugs that have no therapeutic effect or affect the efficacy and stability of the drug, and these impurities may even cause harm to human health.
Therefore, in order to ensure drug safety, companies need to conduct drug impurity analysis and control the impurity content in the drug.
The so-called drug impurities are active pharmaceutical ingredients (API, bulk drug) or undesirable chemical ingredients in pharmaceutical preparations.
Impurities in the drug substance may originate from the synthesis process or other sources such as starting materials, intermediates, solvents, catalysts, and reaction by-products.
Impurities in the drug substance may originate from the synthesis process or other sources such as starting materials, intermediates, solvents, catalysts, and reaction by-products.
Impurities in drugs can be divided into signal impurities and harmful impurities according to their properties.
The signal impurities themselves are generally harmless, but their content can reflect the purity level of the drug.
Harmful impurities are harmful to the human body and must be added in the quality standard.
strict control.
The signal impurities themselves are generally harmless, but their content can reflect the purity level of the drug.
Harmful impurities are harmful to the human body and must be added in the quality standard.
strict control.
During the drug development process, impurities may be generated due to the unstable ingredients of the raw materials, incompatibility with excipients, or reactions with packaging materials.
The amount of various impurities in the drug will affect the safety of the drug.
Therefore, the identification, quantification, qualitative and control of impurities have become a key component of the drug development process.
The amount of various impurities in the drug will affect the safety of the drug.
Therefore, the identification, quantification, qualitative and control of impurities have become a key component of the drug development process.
According to the industry, the various impurity inspection items specified in the pharmacopoeia refer to the impurities that the drug may contain or produce and need to be controlled during the production and normal storage of the drug according to the established process.
Generally, no inspection is required for impurities that are not specified in the Pharmacopoeia for inspection.
The limits of impurities that endanger human health and affect the stability of drugs must be strictly controlled.
Generally, no inspection is required for impurities that are not specified in the Pharmacopoeia for inspection.
The limits of impurities that endanger human health and affect the stability of drugs must be strictly controlled.
It is understood that, in order to better ensure drug safety, relevant drug impurity analysis and testing equipment is constantly being born, and the technology is becoming more and more sophisticated.
For example, the ZW-3 ultraviolet analyzer developed and produced by an enterprise can be used to check the quality of various fluorescent drugs such as hormone alkaloids and vitamins in drug production and research.
Another example is high performance liquid chromatography , this product can effectively separate the components or components of traditional Chinese medicine to be tested from other impurities to achieve the purpose of identification, detection and content determination.
In recent years, high performance liquid chromatograph has been more and more widely used in the inspection of Chinese medicine.
Chromatograph For example, the ZW-3 ultraviolet analyzer developed and produced by an enterprise can be used to check the quality of various fluorescent drugs such as hormone alkaloids and vitamins in drug production and research.
Another example is high performance liquid chromatography , this product can effectively separate the components or components of traditional Chinese medicine to be tested from other impurities to achieve the purpose of identification, detection and content determination.
In recent years, high performance liquid chromatograph has been more and more widely used in the inspection of Chinese medicine.
With the continuous development of technology, these instruments used to detect impurities have played a pivotal role in drug quality control.
In addition, with the continuous development of intelligent technology in recent years, intelligent technology has also been applied in the field of these instruments.
For example, the drug impurity and foreign body detector developed by a company adopts intelligent recognition technology, which has self-learning and memory functions, and can automatically Recognize and memorize the characteristics of products, and effectively eliminate the interference caused by various "product effects".
detector In addition, with the continuous development of intelligent technology in recent years, intelligent technology has also been applied in the field of these instruments.
For example, the drug impurity and foreign body detector developed by a company adopts intelligent recognition technology, which has self-learning and memory functions, and can automatically Recognize and memorize the characteristics of products, and effectively eliminate the interference caused by various "product effects".
The identification, quantification, qualitative and control of impurities are of great significance to the quality and safety control of medicine.
The author has learned that many regulatory agencies, such as the Harmonization Conference (ICH), the U.
S.
Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Canadian Medicines and Health Administration, and the Japanese Medicines and Medical Devices Administration (PMDA), And the Australian Department of Health and Aging Therapeutics are all concerned about the control of impurities.
In addition, many pharmacopoeias, such as the British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Japanese Pharmacopoeia (JP) and European Pharmacopoeia (EP), have also increasingly added impurity limits in APIs and pharmaceutical preparations.
Provisions.
The author has learned that many regulatory agencies, such as the Harmonization Conference (ICH), the U.
S.
Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Canadian Medicines and Health Administration, and the Japanese Medicines and Medical Devices Administration (PMDA), And the Australian Department of Health and Aging Therapeutics are all concerned about the control of impurities.
In addition, many pharmacopoeias, such as the British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Japanese Pharmacopoeia (JP) and European Pharmacopoeia (EP), have also increasingly added impurity limits in APIs and pharmaceutical preparations.
Provisions.
Compared with the 2015 version, my country’s 2020 version of the pharmacopoeia has been revised and increased to a greater extent in the detection of chemical impurities.
The industry said that the new version of the pharmacopoeia is closer to the standard, more suitable for industry development needs, and for drug safety.
The regulation is more stringent.
The industry said that the new version of the pharmacopoeia is closer to the standard, more suitable for industry development needs, and for drug safety.
The regulation is more stringent.
Original title: Drug safety supervision is becoming more and more stringent, and the role of impurity detection equipment continues to be highlighted
