What Are the Different Methods of Pharmaceutical Quality Control?

Drug quality control ^[1] A new drug, which has been proved to be effective and less toxic through pharmacological screening and animal experiments, must be formulated to control the quality of the new drug when it is recommended for clinical trials. The quality and quantity of medicines not only determine the effect of preventing and treating diseases, but also directly affect the safety of patients. Therefore, a clinical drug should have a qualified quality (a certain purity, stability, safety, etc.) of the drug to ensure that it is safe and effective to use. The reason why the quality of drugs must be strictly controlled is also the main basis for the formulation of specifications for new drugs. Drug quality standards should include the following main content: (1) Properties: Record the various physical and chemical properties of the drug, generally including appearance color, solubility, crystal form, melting point, relative density and specific gravity), refractive index, absorption coefficient, etc. It is the characteristics of the drug, and according to these properties, it can help to determine whether it is the inspection product; (2) Identification: mainly considering the chemical reaction. According to the class reaction or characteristic reaction of the drug, specific colors or products are generated with certain divine reagents. Sometimes it is necessary to combine ultraviolet or infrared spectrum to help identify whether the test product is consistent with the product name; (3) Inspection: refers to the impurity burning test. The impurity items that need to be checked are mainly based on the raw materials used in the production of the drug, the preparation method, the storage container and storage process, and possible changes. Considering possible impurities, and then linking the toxicity of these impurities, it is proposed after comprehensive consideration. Generally, there is a certain limit for impurities, and the content of impurities in the drug must not exceed this limit, otherwise it will be unqualified. (4) Determination of content: The main determination method for determining the content of active ingredients in medicines is to be accurate, simple and fast. The commonly used methods in pharmacopoeia include gravimetric analysis, titration analysis, electrochemical analysis, spectrophotometry, and various chromatographic methods.

Drug Quality Control

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Drug quality control ^[1] A new drug, which has been proved to be effective and less toxic through pharmacological screening and animal experiments, must be formulated to control the quality of the new drug when it is recommended for clinical trial. The quality and quantity of medicines not only determine the effect of preventing and treating diseases, but also directly affect the safety of patients. Therefore, a clinical drug should have a qualified quality (a certain purity, stability, safety, etc.) of the drug to ensure that it is safe and effective to use. The reason why the quality of drugs must be strictly controlled is also the main basis for the formulation of specifications for new drugs. Drug quality standards should include the following main content: (1) Properties: Record the various physical and chemical properties of the drug, generally including appearance color, solubility, crystal form, melting point, relative density and specific gravity), refractive index, absorption coefficient, etc. It is the characteristics of the drug, and according to these properties, it can help to determine whether it is the inspection product; (2) Identification: mainly considering the chemical reaction. According to the class reaction or characteristic reaction of the drug, specific colors or products are generated with certain divine reagents. Sometimes it is necessary to combine ultraviolet or infrared spectrum to help identify whether the test product is consistent with the product name; (3) Inspection: refers to the impurity burning test. The impurity items that need to be checked are mainly based on the raw materials used in the production of the drug, the preparation method, the storage container and storage process, and possible changes. Considering possible impurities, and then linking the toxicity of these impurities, it is proposed after comprehensive consideration. In general, there is a certain limit on impurities, and the content of impurities in the drug cannot exceed this limit, otherwise it is unqualified. (4) Determination of content: The main determination method for determining the content of active ingredients in medicines is to be accurate, simple and fast. The commonly used methods in pharmacopoeia include gravimetric analysis, titration analysis, electrochemical analysis, spectrophotometry, and various chromatographic methods.