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Mesalamine USP BP Ph Eur Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Mesalamine or 5-aminosalicylic acid (5-ASA) and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Mesalamine SDS of Manufacturers
Synonyms: Mesalamine or 5-aminosalicylic acid (5-ASA)
CAS Number: 89-57-6, Molecular Weight: 153.14, Chemical Formula: C7H7NO3, EINECS EC Number: 201-919-1, FEMA: ----,
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.
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.
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.
Keywords: Mesalamine or 5-aminosalicylic acid (5-ASA) IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 89-57-6 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
12-sep-24
Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
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Mesalamine
BP Ph Eur USP Grades Manufacturers