Imatinib Mesylate Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Imatinib Mesylate, 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 etc.

The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer.

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Imatinib Mesylate: CAS Number: 220127-57-1, EINECS EC Number: 606-892-3, Molecular Formula: C30H35N7O4S or C29H31N7O-CH4SO3, Molecular Weight: 589.7, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Imatinib Mesylate.

Imatinib mesylate is a white to off-white crystalline powder. Its molecular formula is C29H31N7O-CH4SO3. Imatinib Mesylate is the mesylate salt of imatinib, a tyrosine kinase inhibitor with antineoplastic activity. Soluble in aqueous buffers =<pH 5.5, but very slightly soluble in neutral to alkaline aqueous buffers; freely soluble to very soluble in dimethyl sulfoxide, methanol, and ethanol; insoluble in n-octanol, acetone, and acetonitrile.
Chemical Name: 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide methanesulfonate

Specifications of Imatinib Mesylate:
CAS Number: 220127-57-1
Molecular Formula: C30H35N7O4S or C29H31N7O-CH4SO3
Molecular Weight: 589.70
Description: White to yellowish white powder.
Identification: By IR.
Solubility: Freely soluble in water and sparingly soluble in methanol.
Melting Range: 209C to 225C.
Moisture Content by KF: Not more than 0.5%.
Heavy Metals: Not more than 20 ppm In-house
Related substances by HPLC
a) Individual Impurity Not more than 0.5%
b) Total Impurities Not more than 1.0%
Assay by HPLC (on anhydrous basis): 99.0 to 101.0%.
Storage: Well-closed container, protected from direct sunlight and moisture.

Imatinib Mesilate BP Ph Eur Grade:
Ph Eur
C30H35N7SO4 --- 589.7 --- CAS 220127-57-1
Action and use: Cytotoxic.

DEFINITION
4-[(4-Methylpiperazin-1-yl)methyl]-N-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino]phenyl]benzamide methanesulfonate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

PRODUCTION
It is considered that alkyl methanesulfonate esters are genotoxic and are potential impurities in imatinib mesilate. The manufacturing process should be developed taking into consideration the principles of quality risk management, together with considerations of the quality of starting materials, process capability and validation. The general methods 2.5.37. Methyl, ethyl and isopropyl methanesulfonate in methanesulfonic acid, 2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances and 2.5.39. Methanesulfonyl chloride in methanesulfonic acid are available to assist manufacturers.

CHARACTERS
Appearance: White or almost white, slightly brownish or yellowish powder; yellow or pale yellow, very hygroscopic, for the amorphous form.
Solubility: Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. It shows polymorphism.

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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)

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Product Name/Synonyms: Imatinib Mesylate or 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide methanesulfonate.
CAS No.: 220127-57-1
EINECS EC Number: 606-892-3
Molecular Weight: 589.7
Chemical Formula: C30H35N7O4S or C29H31N7O-CH4SO3
Recommended usage: 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

Precautionary statements:
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
P273: Avoid release to the environment.
P330: Rinse mouth.
P362: Take off contaminated clothing and wash before reuse.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P332+313: If skin irritation occurs: Get medical advice/attention.
P302+ P352 - IF ON SKIN: Wash with plenty of soap and water.
P305+ P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/ attention.
P501: Dispose of contents/container to authorized agents only.

Labeling in accordance with Directive 67/548/EEC:
Xn Harmful
R22: Harmful if swallowed.

Inhalation: Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Keep person warm and quiet; get medical attention.
Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact: Immediately flush skin with plenty of soap and water for at least 15 minutes. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention if irritation develops.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention.
Notes to Physician: Treat symptomatically

Fire: It is not considered to be a fire hazard. However it will burn at high temperature.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Use water spray to cool fire-exposed containers.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Sulphur oxides, Fumes.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece.

Use personal protective equipment. Avoid dust formation. Avoid breathing dust, vapors, mist or gas. Ensure adequate ventilation. Avoid breathing dust. Do not let product enter drains.
Ventilate area of leak or spill. Wear appropriate personal protective equipment. Pick up spills and place in a suitable container for reclamation or disposal, using a method that does not generate dust.

Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Avoid ingestion and inhalation. Keep in a tightly closed container, stored in a cold, dry, ventilated area. Protect against physical damage. Avoid dust formation and control ignition sources. Isolate from incompatible substances. Containers of may be hazardous when empty.

Airborne Exposure Limits: None established.
Ventilation System: In general, dilution ventilation is a satisfactory health hazard control for this substance. However, if conditions of use create discomfort to the worker, a local exhaust system should be considered.
Personal Respirators (NIOSH Approved): Not expected to require personal respirator usage. 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.
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.

Appearance: White to yellowish white powder.
Odor: Odorless.
Solubility: Freely soluble in water and sparingly soluble in methanol.
pH: No information found.
Boiling Point: Decomposes.
Melting Point: 209C to 225C literature.
Flash Point: No data available.
Auto-ignition temperature: No data available.
Molecular Weight: 589.7
Chemical Formula: C30H35N7O4S or C29H31N7O-CH4SO3.

Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: May produce oxides of nitrogen, sulfur and carbon along with fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting and incompatibles.

Toxicity Data:
Oral TDLO (human): 79.8 mg/kg/1W (intermittent)
Oral TDLO (man): 60.2 mg/kg/1W
Oral TDLO (rat): 450 mg/kg/3D (intermittent)
Oral TDLO (mouse): 600 mg/kg/6D (intermittent)
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: No information available
Reproductive Effects: No information available.
Developmental Effects: No information available.
Teratogenicity: No information available.

Environmental Fate: Not available.
Persistence and degradability: No data available
Toxicity: No data available
Bioaccumulative potential: No data available
Mobility in soil: No data available
PBT and vPvB assessment: no data available

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. Dispose of container and unused material in accordance with legal requirements.

DOT: Not regulated
TDG: Not regulated
IATA: Not regulated
IMDG/IMO: Not regulated
ADR/RID: Not regulated

USA:
SARA 302: Not applicable.
SARA 313: Not applicable.
SARA 311/312 Hazardous Categorization: Acute Health Hazard.
California Proposition 65: This product does not contain any Proposition 65 chemicals

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