CAS Number 89-57-6, Mesalamine or Mesalazine or 5-Aminosalicylic Acid USP BP Ph Eur Grade Manufacturers Exporters
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CAS Number 89-57-6, Mesalamine or Mesalazine or 5-Aminosalicylic Acid USP BP Ph Eur Manufacturer Exporter
For Properties Specifications of Mesalamine or Mesalazine or 5-Aminosalicylic Acid Click Properties, Specifications of Mesalamine or Mesalazine or 5-Aminosalicylic Acid Manufacturer.
For Uses of Mesalamine or Mesalazine or 5-Aminosalicylic Acid Click Uses of Mesalamine or Mesalazine or 5-Aminosalicylic Acid Manufacturer.
For For SDS MSDS Sheet of Mesalamine or Mesalazine or 5-Aminosalicylic Acid Click SDS Safety Data Sheet MSDS Sheet of Mesalamine or Mesalazine or 5-Aminosalicylic Acid Manufacturer.
The Properties and Specifications of 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 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.
The Uses of Mesalamine or Mesalazine or 5-Aminosalicylic Acid:
Mesalamine or Mesalazine or 5-aminosalicylic acid is a medication used to treat inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease.The MSDS-SDS Hazard Statement of Mesalamine or Mesalazine or 5-Aminosalicylic Acid:
Mesalamine or Mesalazine or 5-Aminosalicylic Acid Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 05-Nov-24
1. Product Identification
Product Name & Other Names: Mesalamine or Mesalazine or 5-Aminosalicylic Acid.
CAS No.: 89-57-6
EINECS EC Number: 201-919-1
Relevant uses and uses advised against (if any): R & D Laboratory in industrial manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Skin irritation Category 2, H315
Sensitization, Skin Category 1 317
Serious eye irritation/damage Category 2A, H319
Specific target organ toxicity (single exposure), Category 3, H335
Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements  Irritant |
Signal Words<: Warning
Hazard statements:
H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
Precautionary statements:
P264 Wash thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P330 : Rinse mouth
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P308+313: IF exposed or concerned: Get medical advice/attention.
3. Composition/Information on Ingredients
Product Name & Other Names: Mesalamine or Mesalazine or 5-Aminosalicylic Acid.
CAS No.: 89-57-6
EINECS EC Number: 201-919-1
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: Allow the victim to rest in a well-ventilated area. Seek immediate medical attention.
Ingestion: Give large amounts of water to drink. Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes and wash before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Get medical attention immediately.
5. Fire Fighting Measures
Fire: As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Explosion: Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust explosion hazard.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Fumes.
Fire Extinguishing Media: Water spray, dry chemical, alcohol foam, or carbon dioxide. Avoid solid water jet as it can spread the fire.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Small Spill: Dilute with water and mop up or absorb with an inert dry material and place in an appropriate waste disposal container.
Large Spill: Contain spilled material. Cover with an inert material and put the spilled material in an appropriate waste disposal.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizers and strong acids. Store away from sources of heat and moisture. Storage: 0-4C. Refrigerate. Light sensitive.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: None established.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator (NIOSH type N95 or better filters) may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: White to pinkish crystals or purplish-tan powder.
Odor: Odorless.
Odor threshold: Not applicable.
pH: about 4.1 at 0.8 mg/L in water.
Relative density: No data found.
Melting point/freezing point: 275C to 280C literature.
Initial boiling point and boiling range: No data found.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Slightly soluble in water, alcohol; more soluble in hot water.
Viscosity: No data found.
10. Stability and Reactivity
Stability: Stable under recommended conditions of use and storage. Sensitive to moisture.
Hazardous Decomposition Products: When heated to decomposition it emits toxic fumes of nitrogen oxide, carbon oxides.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizers, strong acids.
Conditions to Avoid: Incompatibles, moisture, light.
11. Toxicological Information
Acute toxicity:
LD50 Oral – Rat: 2800 mg/kg.
Carcinogenic Effects: Not a reported carcinogen by IARC NTP ACGIH OSHA.
Mutagenic Effects: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.
12. Ecological Information
Toxicity: The environmental impact of this product has not been fully investigated.
Persistence and Degradability: No data found.
Mobility: No data found.
Bioaccumulation/ Accumulation: No data found.
Results of PBT and vPvB assessment: No data available for assessment.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMO/IMDG: Not regulated.
IATA: Not regulated.
15. Regulatory Information
USA:
SARA 311/312 Hazard Categories: See section 2.
California Proposition 65: Not listed.
16. Other Information
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Mesalamine or Mesalazine or 5-Aminosalicylic Acid Structure
CAS Number 89-57-6, Mesalamine or Mesalazine or 5-Aminosalicylic Acid Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 19-nov-24
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