Mesalamine or Mesalazine or 5-Aminosalicylic Acid USP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Mesalamine or Mesalazine or 5-Aminosalicylic Acid USP BP Ph Eur Grade, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Mesalamine or Mesalazine or 5-Aminosalicylic Acid CAS Number 89-57-6, EINECS EC Number: 201-919-1, Molecular Formula: C7H7NO3, Molecular Weight: 153.14, HS Code 29225090

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Mesalamine or Mesalazine or 5-Aminosalicylic Acid.

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.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

Exporters to USA Canada UAE Europe South Africa Tanzania Kenya Uganda Egypt Nigeria Turkey Mexico Brazil Argentina Chile Dubai etc.

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Mesalamine or Mesalazine or 5-Aminosalicylic Acid Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 27-Dec-23

Product Name & Other Names: Mesalamine or Mesalazine or 5-Aminosalicylic Acid.
CAS No.: 89-57-6
EINECS EC Number: 201-919-1
Molecular Weight: 153.14
Chemical Formula: C7H7NO3
Relevant uses and uses advised against (if any): R & D Laboratory in industrial manufacturing.
Suppliers: As per letterhead.

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

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.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xn Harmful
Xi Irritant.
Risk Phrases:
R36/37/38 Irritating to eyes, respiratory system, and skin.
R43 May cause sensitization by skin contact.

Product Name & Other Names: Mesalamine or Mesalazine or 5-Aminosalicylic Acid.
CAS No.: 89-57-6
EINECS EC Number: 201-919-1

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.

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.
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. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

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. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
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. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal authority requirements.
Large Spill: Contain spilled material. Cover with an inert material and put the spilled material in an appropriate waste disposal. Finish cleaning by spreading water on the contaminated surface and dispose of it according to legal authority requirements.

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. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
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.

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. Local exhaust ventilation is preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
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. If oil particles (e.g., lubricants, cutting fluids, glycerin, etc.) are present, use a NIOSH type R or P filter. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator. WARNING: Air-purifying respirators do not protect workers in oxygen-deficient atmospheres.
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.

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: Not available.
Melting point/freezing point: 275C to 280C literature.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Slightly soluble in water, alcohol; more soluble in hot water.
Viscosity: Not available.
Molecular Weight: 153.14
Chemical Formula: C7H7NO3

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.

Acute toxicity:
LD50 Oral – Rat: 2800 mg/kg.
Carcinogenic Effects: Not a reported carcinogen by IARC NTP ACGIH OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity: The environmental impact of this product has not been fully investigated.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused material in accordance with legal requirements.

DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMO/IMDG: Not regulated.
IATA: Not regulated.

USA:
SARA 311/312 Hazard Categories: Acute health hazard, Chronic Health Hazard.
California Proposition 65: This product does not contain any Proposition 65 chemicals.

European Labeling in Accordance with EC Directives:
H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
H319: Causes serious eye damage.
H335: May cause respiratory irritation.

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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