Pharmaceutical excipients refer to inactive substances that are added to drugs during the preparation process and play a role in increasing volume, improving texture, stability or improving drug efficacy, and usually do not have pharmacological activity. Pharmaceutical excipient ingredient testing refers to the detection and analysis of excipient components contained in drugs. By testing the components of pharmaceutical excipients, the quality and safety of the formulation can be ensured, and it can provide a reference for production process improvement and quality control.
1. Detection scope of pharmaceutical excipient ingredients
Magnesium stearate, silicon dioxide, cellulose, pharmaceutical coating, dextrin, glycerin, starch and other pharmaceutical excipients.
2. Testing items for pharmaceutical excipient ingredients
Physical constants: melting point, freezing point, optical rotation, refraction, pH, viscosity, conductivity, TOC, etc.
Characteristic detection: color, clarity, crystallization, particle size, density, etc.
Limit check: chloride, iron salt, ammonium salt, heavy metal, arsenic salt, moisture, etc.
3. Testing standards for pharmaceutical excipients
YY0143-1993 Medicinal excipients tartrazine.
YY0204-1995 Sodium bisulfite for pharmaceutical excipients.
YY0205-1995 Pharmaceutical excipients anhydrous sodium sulfite.
GB 2760 National Food Safety Standard Standard for the Use of Food Additives.
gb 4789.2-2016 National Food Safety Standard Food Microbiology Inspection Food Microbiology Inspection Part 2: Food Hygiene Inspection.
gb 4789.3-2016 National Food Safety Standard Food Microbiology Inspection Food Microbiology Inspection Part 3: Hygienic Monitoring of Food Production Process.
GB 31604 National Standard for Food Safety.
GB 1886 National Food Safety Standard Standard for the Use of Plastic Additives in Food Contact Materials and Products.
gb 5009.3-2016 National Food Safety Standard Testing for Pesticide Residues in Food Part 3: Determination of PCB and PCB Residues in Food Gas Chromatography.
gb/t 5009.148 National Food Safety Standard Determination of aflatoxin B1 in food High performance liquid chromatography.
Fourth, the testing process
1. **Consultation, **communication or face-to-face interview with Century Jiuhai.
2. Send samples, special samples can provide door-to-door sampling services.
3. Contract signing (payment).
4. Sample analysis and inspection engineer analysis summary report.
5. Send you a report, and the engineer will take the initiative to pay a return visit after sales to solve your after-sales doubts.
The above is an introduction to the testing of pharmaceutical excipient components, through the detection and analysis of the excipient components used in the drug to ensure their quality and safety. We should pay attention to the quality of the product when choosing pharmaceutical excipients, the best pharmaceutical excipients are helpful to our production, for more details, please consult Century Jiuhai!