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Mesalamine or 5-Aminosalicylic Acid

CAS No.: 89-57-6
Molecular Weight: 153.14 g/mol
Chemical Formula C7H7NO3

Mesalamine or Mesalazine or 5-aminosalicylic acid (5-ASA), is a medication used to treat inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease.

General Properties and Specifications of Mesalamine or Mesalazine or 5-Aminosalicylic Acid:
Appearance: White to pinkish crystals or purplish-tan powder.
Odor: Odorless.
Assay: 98.5% minimum.
pH: about 4.1 at 0.8 mg/L in water.
Melting Point: 275C to 280C literature.
Solubility: Slightly soluble in water, alcohol; more soluble in hot water.
Storage: 0-4C. Refrigerate.

Mesalamine USP Grade Specifications:
C7H7NO3 --- 153.14
Benzoic acid, 5-amino-2-hydroxy-;
5-Aminosalicylic acid CAS 89-57-6
UNII: 4Q81I59GXC

DEFINITION
Mesalamine contains NLT 98.5% and NMT 101.5% of mesalamine (C7H7NO3 ), calculated on the dried basis.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the mesalamine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Chloride and Sulfate, Chloride: No more chloride than corresponds to 0.7 mL of 0.020 N hydrochloric acid (0.1%)
Chloride and Sulfate, Sulfate: No more sulfate than corresponds to 1.0 mL of 0.02 N sulfuric acid (0.2%).
Residue on Ignition: NMT 0.2%
Hydrogen Sulfide and Sulfur Dioxide: To pass the test.
Content of 3-Aminosalicylic Acid and Other Related Impurities: To pass the test.
Content of Aniline, 2-Aminophenol, and 4-Aminophenol: To pass the test.
Clarity of Solution: Freshly prepare a solution of 0.25 g of Mesalamine in 10 mL of 1 N hydrochloric acid. The Sample solution is clear.
Loss on Drying: Dry under vacuum at 105C for 3 h.
Acceptance criteria: NMT 0.5%
pH: 3.5–4.5in a suspension (1 in 40).

Mesalazine BP Ph Eur Grade:
C7H7NO3 --- 153.1 CAS 89-57-6
Action and use: Aminosalicylate; treatment of ulcerative colitis.

DEFINITION
5-Amino-2-hydroxybenzoic acid.
Content: 98.5 per cent to 101.5 per cent (dried substance).

CHARACTERS
Appearance: Almost white or light grey or light pink powder or crystals.
Solubility: Very slightly soluble in water, practically insoluble in ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides and in dilute hydrochloric acid.

IDENTIFICATION
First identification: B
Second identification: A, C
A. Ultraviolet and visible absorption spectrophotometry.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.

Appearance of solution: Maintain the solutions at 40C during preparation and measurements. Dissolve 0.5 g in 1 M hydrochloric acid and dilute to 20 mL with the same acid. The solution is clear. Immediately measure the absorbance of the solution at 440 nm and 650 nm. The absorbance is not greater than 0.15 at 440 nm and 0.10 at 650 nm.
Reducing substances: Dissolve 0.10 g in dilute hydrochloric acid and dilute to 25 mL with the same acid. Add 0.2 mL of starch solution and 0.25 mL of 0.01 M iodine. Allow to stand for 2 min. The solution is blue or violet-brown.
Impurities A, C and K: To pass the test.
Related substances: To pass the test.
Chlorides: Maximum 0.1 per cent.
Sulfates: Maximum 200 ppm.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.2 per cent, determined on 1.0 g.