Mesalamine Ip/bp/usp - Application: Pharmaceutical Industry

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