APIs

Sure here are the short specifications for Mesalazine according to different pharmacopeias Indian Pharmacopoeia IP British Pharmacopoeia BP and United States Pharmacopeia USP Mesalazine IP Indian Pharmacopoeia 1 Chemical Name 5Aminosalicylic acid 2 Molecular Formula C7H7NO3 3 Molecular Weight 15314 gmol 4 Appearance A white or light pink crystalline powder 5 Solubility Sparingly soluble in water Soluble in dilute acids and alkalis 6 Identification Infrared Absorption Spectrophotometry Chromatographic methods 7 Assay Contains not less than 985 and not more than 1010 of C7H7NO3 calculated on the dried basis 8 Impurities Related substances Specific limits for individual and total impurities Heavy metals Not more than specified limit 9 Loss on Drying Not more than 05 10 Storage Store in a wellclosed container protected from light Mesalazine BP British Pharmacopoeia 1 Chemical Name 5Aminosalicylic acid 2 Molecular Formula C7H7NO3 3 Molecular Weight 15314 gmol 4 Appearance A white or light pink crystalline powder 5 Solubility Sparingly soluble in water Soluble in dilute acids and alkalis 6 Identification Infrared Absorption Spectrophotometry Chromatographic methods 7 Assay Contains not less than 990 and not more than 1010 of C7H7NO3 calculated on the dried basis 8 Impurities Related substances Specific limits for individual and total impurities Heavy metals Not more than specified limit 9 Loss on Drying Not more than 05 10 Storage Store in a wellclosed container protected from light Mesalazine USP United States Pharmacopeia 1 Chemical Name 5Aminosalicylic acid 2 Molecular Formula C7H7NO3 3 Molecular Weight 15314 gmol 4 Appearance A white to pinkish crystalline powder 5 Solubility Sparingly soluble in water Soluble in dilute hydrochloric acid and in dilute solutions of alkali hydroxides 6 Identification Infrared Absorption Chromatographic methods 7 Assay Contains not less than 980 and not more than 1020 of C7H7NO3 calculated on the dried basis 8 Impurities Related substances Specific limits for individual and total impurities Heavy metals Not more than specified limit 9 Loss on Drying Not more than 05 10 Storage Preserve in tight containers protected from light These specifications ensure the quality purity and efficacy of mesalazine in pharmaceutical preparations