Comparative Analysis of Quality Assessment Requirements for Gelatin Used in Drug Production (Review)

Resumo

Gelatin is usually used as an excipient in drug preparations and more rarely as an active ingredient. Domestic quality standards regulating gelatin used in drug production were enacted over 20 years ago. A comparative analysis of quality requirements for gelatin in domestic and foreign pharmacopoeias seemed timely in order to justify national pharmacopoeial quality requirements for gelatin (quality parameters, analysis methods, norms) and to compose a pharmacopoeial monograph for gelatin in the RF State Pharmacopoeia.