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Mesalamine or Mesalazine or 5-aminosalicylic acid
CAS Number: 89-57-6
Molecular Formula: C7H7NO3
Molecular Weight: 153.14
Mesalamine or Mesalazine or 5-aminosalicylic acid
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 is also available as per BP Ph Eur monograph.
Please visit SDS Safety Data Sheet of Mesalamine Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org