Common testing instruments in the pharmaceutical industry.
Common testing instruments in the pharmaceutical industry.
1. Drug safety is related to the health and life safety of the people. Drug supervision should be comprehensively strengthened to improve drug safety supervision technology and improve the drug inspection and testing system.
2. Drug research and development, production and marketing units must not only meet daily supervision and inspections, but also need to carry out comprehensive development in accordance with the requirements of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Manufacturing Practice (GSP) and other requirements. Systematic full project inspection. During unannounced inspections, the pass rate of drug supervision sampling inspections will be improved.
3. Inspection and testing of drugs and excipients include character inspection, physical and chemical properties, impurity inspection and content determination. Character inspection includes acid value, hydroxyl value, iodine value, peroxide value, saponification value. Physical and chemical properties and impurity inspection include functional related index inspection, pH, solution clarity and color, inorganic anions (chloride, sulfate, Sulfide, phosphate and other anions), etc.
4. When measuring constant components, volumetric analysis has the advantages of good precision, simple and rapid operation, and is therefore the preferred method for content determination.
5.Volumetric analysis methods include acid-base titration method, non-aqueous titration method, redox titration method (iodine method, bromine method and potassium bromate method, cerium method, potassium permanganate method, potassium periodate method), precipitation titration ( Silver volume method, sodium tetraphenylborate method), complex titration method (aminocarboxylate complexing agent method, mercury volume method, silver ammonia complex method), diazotization titration method, etc.
Standards
Chinese Pharmacopoeia
Recommended instruments
1. Automatic titrator
2.Karl Fischer moisture meter
3. Turbidimeter
4. PH meter
5. Conductivity meter
6. Ion meter
1. Drug safety is related to the health and life safety of the people. Drug supervision should be comprehensively strengthened to improve drug safety supervision technology and improve the drug inspection and testing system.
2. Drug research and development, production and marketing units must not only meet daily supervision and inspections, but also need to carry out comprehensive development in accordance with the requirements of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Manufacturing Practice (GSP) and other requirements. Systematic full project inspection. During unannounced inspections, the pass rate of drug supervision sampling inspections will be improved.
3. Inspection and testing of drugs and excipients include character inspection, physical and chemical properties, impurity inspection and content determination. Character inspection includes acid value, hydroxyl value, iodine value, peroxide value, saponification value. Physical and chemical properties and impurity inspection include functional related index inspection, pH, solution clarity and color, inorganic anions (chloride, sulfate, Sulfide, phosphate and other anions), etc.
4. When measuring constant components, volumetric analysis has the advantages of good precision, simple and rapid operation, and is therefore the preferred method for content determination.
5.Volumetric analysis methods include acid-base titration method, non-aqueous titration method, redox titration method (iodine method, bromine method and potassium bromate method, cerium method, potassium permanganate method, potassium periodate method), precipitation titration ( Silver volume method, sodium tetraphenylborate method), complex titration method (aminocarboxylate complexing agent method, mercury volume method, silver ammonia complex method), diazotization titration method, etc.
Standards
Chinese Pharmacopoeia
Recommended instruments
1. Automatic titrator
2.Karl Fischer moisture meter
3. Turbidimeter
4. PH meter
5. Conductivity meter
6. Ion meter
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