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[ Policies and Regulations of Chemical Machinery and Equipment Network ] Not long ago, the state * announced that 10 batches of drugs did not meet the requirements.
After inspection, 10 batches of drugs produced by 10 companies did not meet the requirements.
The items that do not meet the requirements mainly involve impurities, properties, and microbial limits.
Chemical Machinery and Equipment Network Policies and Regulations Chemical Machinery and EquipmentAfter inspection, 10 batches of drugs produced by 10 companies did not meet the requirements.
The items that do not meet the requirements mainly involve impurities, properties, and microbial limits.
The so-called drug impurities are active pharmaceutical ingredients (API, bulk drug) or undesirable chemical ingredients in pharmaceutical preparations.
According to its nature, it can be divided into signal impurities and harmful impurities.
The signal impurities themselves are generally harmless, but their content can reflect the purity level of the drug, and harmful impurities often affect human health and need to be strictly controlled.
According to its nature, it can be divided into signal impurities and harmful impurities.
The signal impurities themselves are generally harmless, but their content can reflect the purity level of the drug, and harmful impurities often affect human health and need to be strictly controlled.
The industry pointed out that in the process of drug development, impurities may be generated due to unstable ingredients of the raw materials, incompatibility with excipients, or reactions with packaging materials.
And the amount of various impurities in the medicine will affect the safety of the medicine.
Therefore, the identification, quantification, qualitative and control of impurities have become a key component of the drug development process.
And the amount of various impurities in the medicine will affect the safety of the medicine.
Therefore, the identification, quantification, qualitative and control of impurities have become a key component of the drug development process.
However, in the past drug inspection process, impurities can be said to be one of the common non-compliant items, which is worrying.
In order to improve the safety of drugs, relevant policies and regulations have been continuously promulgated and improved.
For example, the 2020 edition of the Pharmacopoeia will be implemented on December 30, 2020.
It can be noted that, in order to strengthen the coordination of standards, the new edition of the Pharmacopoeia refers to the relevant guidelines of the Coordination Council for the Coordination of Technical Requirements for the Registration of Human Drugs (ICH).
Among them, the chemical impurity detection has been revised and increased to a greater extent compared with the 2015 version.
As a whole, it is closer to the standard, and the supervision of drug safety is also stricter.
In order to improve the safety of drugs, relevant policies and regulations have been continuously promulgated and improved.
For example, the 2020 edition of the Pharmacopoeia will be implemented on December 30, 2020.
It can be noted that, in order to strengthen the coordination of standards, the new edition of the Pharmacopoeia refers to the relevant guidelines of the Coordination Council for the Coordination of Technical Requirements for the Registration of Human Drugs (ICH).
Among them, the chemical impurity detection has been revised and increased to a greater extent compared with the 2015 version.
As a whole, it is closer to the standard, and the supervision of drug safety is also stricter.
It is not difficult to foresee that with the implementation of the new pharmacopoeia, strengthening drug impurity analysis and testing and controlling the impurity content in drugs will be a major issue for pharmaceutical companies, which will also have great significance for ensuring the safety of drugs and ensuring the safety of medications for patients.
In this context, the analysis and testing equipment related to drug impurities will play a significant role in the drug quality control process, and the equipment market will usher in room for development.
For example, high performance liquid chromatography , this product has the characteristics of high separation efficiency, sensitivity and rapidity, and can effectively separate the components or components of Chinese medicine to be tested from other impurities to achieve the purpose of identification, detection and content determination.
In recent years, high performance liquid chromatographs have been used more and more widely in the field of traditional Chinese medicine.
Chromatograph For example, high performance liquid chromatography , this product has the characteristics of high separation efficiency, sensitivity and rapidity, and can effectively separate the components or components of Chinese medicine to be tested from other impurities to achieve the purpose of identification, detection and content determination.
In recent years, high performance liquid chromatographs have been used more and more widely in the field of traditional Chinese medicine.
However, while related equipment is ushering in opportunities, challenges also coexist.
For example, many users have reported that in the actual verification process, gas chromatographs often have problems such as unconnected connectors and low detection accuracy.
This will pose challenges to manufacturers in terms of equipment structure design and sensitivity, requiring companies to continuously break through the bottleneck and strengthen innovation so that the equipment can better meet the needs of drug impurity testing.
For example, many users have reported that in the actual verification process, gas chromatographs often have problems such as unconnected connectors and low detection accuracy.
This will pose challenges to manufacturers in terms of equipment structure design and sensitivity, requiring companies to continuously break through the bottleneck and strengthen innovation so that the equipment can better meet the needs of drug impurity testing.
The author understands that, in the face of the expanding demand for drug impurity testing, relevant equipment manufacturers are also making further arrangements and gradually transforming to a provider of drug impurity testing solutions.
For example, some companies continue to expand their product lines, which can currently cover various impurity testing needs such as organic impurities, inorganic impurities, and solvent residues.
The company also continues to improve informatics, chromatographic columns and consumables, after-sales service and training support systems to help users Effectively face the challenges of complex drug impurity analysis.
For example, some companies continue to expand their product lines, which can currently cover various impurity testing needs such as organic impurities, inorganic impurities, and solvent residues.
The company also continues to improve informatics, chromatographic columns and consumables, after-sales service and training support systems to help users Effectively face the challenges of complex drug impurity analysis.
There are also companies that are committed to providing truly compliant, comprehensive, effective, and innovative drug safety* solutions for drug production and supervision.
The newly released "Pharmaceutical Element Impurities Testing Solution" covers all aspects from sample pre-processing to experimental data compliance processing.
All links are designed to help pharmaceutical companies cope with the changes in the 2020 Chinese Pharmacopoeia smoothly.
The newly released "Pharmaceutical Element Impurities Testing Solution" covers all aspects from sample pre-processing to experimental data compliance processing.
All links are designed to help pharmaceutical companies cope with the changes in the 2020 Chinese Pharmacopoeia smoothly.
In general, the new version of the pharmacopoeia has become a trend to conform to the standards.
Under this background, the detection of drug impurities will also be paid more attention by pharmaceutical companies.
While seizing the opportunities, manufacturers of impurity analysis and testing equipment also need to do a good job in meeting the challenges.
Prepare, continue to overcome difficulties, and escort drug safety.
Under this background, the detection of drug impurities will also be paid more attention by pharmaceutical companies.
While seizing the opportunities, manufacturers of impurity analysis and testing equipment also need to do a good job in meeting the challenges.
Prepare, continue to overcome difficulties, and escort drug safety.
Original title: The new version of the Pharmacopoeia is in line with standards, and impurity testing equipment will be promising
