Working on CDMO for Macromolecular Target Drugs
We provide testing services for packaging material, specification of pharmaceutical excipients and analysis&test services, safety evaluation services for packaging material and pharmaceutical excipients, etc.
◆ Pharmaceutical excipient: meets the specification system of relevant regulations, such as ChP, USP, and EP. The testing items cover that related to production and safety, such as properties, identification, inspection, content determination, etc; and functional relevant indicators that affect preparation performance, such as viscosity, particle size, etc.; as well as routine safety tests, such as microbial limit or sterility test, pyrogen and (or) bacterial endotoxin test, and abnormal toxicity test, etc.;
◆ Packaging material: own antibiotic aluminum-plastic combination cover, middle borosilicate glass tubular injection bottle, middle borosilicate glass molded injection bottle, brominated butyl rubber plug for injection, brominated butyl rubber plug partially covered with polytetrafluoroethylene film for injection, quality control system of pre-filled syringe unit (with injection needle/without injection needle), which covers the physical properties of pharmaceutical packaging material, such as puncture strength and puncture debris of rubber products, closure of plastic and composite film products, particle water-resistance and inner surface water resistance of glass drug packaging materials, and the opening force and coating firmness of aluminum-plastic composite covers, etc.;
◆ Chemical properties: dissolution test, solvent residues, etc.;
◆ Biological properties: cytotoxicity, acute systemic toxicity, and hemolysis test, etc.