Olanzapine USP IP BP Ph Eur EP Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Olanzapine USP IP BP Ph Eur EP 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. 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. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Olanzapine CAS Number 132539-06-1, EINECS EC Number: 603-618-4, Molecular Formula: C17H20N4S, Molecular Weight: 312.44, HS Code 29349990
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SDS MSDS Sheet of Olanzapine Manufacturers
Olanzapine
USP IP BP Ph Eur EP Grade Suppliers
Olanzapine is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder.
Olanzapine USP Grade Specifications:
C17H20N4S --- 312.43
10H -Thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-;
2-Methyl-4-(4-methyl-1-piperazinyl)-10H -thieno[2,3-b][1,5] benzodiazepine
CAS: 132539-06-1
UNII: N7U69T4SZR
DEFINITION
Olanzapine contains NLT 98.0% and NMT 102.0% of olanzapine (C17H20N4S), calculated on the anhydrous, solvent-free basis.
IDENTIFICATION
A. Infrared Absorption.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography.
Water Determination: NMT 1.0%
Packaging and Storage: Preserve in well-closed containers, and store at room temperature.
Olanzapine BP Ph Eur Grade:
C17H20N4S --- 312.4 CAS 132539-06-1
Action and use: Dopamine D2 receptor antagonist; serotonin 5HT2 receptor antagonist; neuroleptic.
DEFINITION
2-Methyl-4-(4-methylpiperazin-1-yl)-10H-thieno[2,3-b][1,5]benzodiazepine.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: Yellow, crystalline powder.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, slightly soluble in ethanol (96 per cent). It shows polymorphism.
IDENTIFICATION
Infrared absorption spectrophotometry.
TESTS
Related substances: To pass the test by Liquid chromatography.
We manufacture Olanzapine USP IP BP Ph Eur EP Grade.
For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.
We also manufacture and supply as under:
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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e-mail: info@mubychem.com
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Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)
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Last
23 September, 2024
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Olanzapine SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 22-Sept-24
1. Product Identification
Product Name & Other Names: Olanzapine.
CAS No.: 132539-06-1
EINECS EC Code: 603-618-4
Molecular Weight: 312.44
Chemical Formula: C17H20N4S
Relevant uses and uses advised against (if any): 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
Acute toxicity, Oral (Category 3) H301
Skin corrosion (Category 1B) H315
Skin sensitization (Category 1) H317
Eye irritation (Category 2) H319
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Toxic |
GHS Label Elements |
Signal Word: Danger
Hazard Statements:
H301: Toxic if swallowed
H315: Causes skin irritation.
H317: May cause an allergic skin reaction
H319: Causes serious eye irritation.
Precautionary Statements
P202: Do not handle until all safety precautions have been read and understood.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P272: Contaminated work clothing should not be allowed out of the workplace
P280-Wear protective gloves/protective clothing/eye protection/face protection.
P284 Wear respiratory protection.
P301+P310+330: IF SWALLOWED: Rinse mouth and immediately call a POISON CENTER or doctor/physician.
P302+P352: IF ON SKIN: Wash with soap and water.
P303+P361+P352: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Wash with plenty of soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P304+P341+P311: IF INHALED: If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTER or doctor/physician.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P314: Get Medical advice/attention if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice/ attention.
P360: Rinse immediately contaminated clothing and skin with plenty of water before removing clothes.
P403+P233 Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents/container in accordance with local/regional/national/international regulations.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
T Toxic
Xi Irritant
Risk Phrase:
R25 Toxic if swallowed
R36/38 Irritating to eyes and skin
R43 May cause sensitization by skin contact.
3. Composition/Information on Ingredients
Product Name & Other Names: Olanzapine.
CAS No.: 132539-06-1
EINECS EC Code: 603-618-4
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: Remove the victim to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Toxic if swallowed. Contact the medical center quickly. Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: On contact, it can cause itching, pain, swelling and redness. Immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse.
Eye Contact: It can cause severe irritation and harm to eyes. Check for and remove any contact lenses. Immediately flush your eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Get medical attention.
5. Fire Fighting Measures
Fire: Toxic fumes, sulfur oxides, nitrogen oxide, carbon dioxide and carbon monoxide may be formed in fire.
Explosion: No data available
Fire Extinguishing Media: Dry chemical, foam or carbon dioxide and water spray jet. Avoid solid water jet as it can scatter 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. 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: Sweep and shovel and dispose of as hazardous waste. Keep in suitable, closed containers for disposal. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law. Keep away from heat. Keep away from sources of ignition.
7. Handling and Storage
Precautions for safe handling: Toxic. Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. 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.). 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. 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 oxidizing agents. Keep away from heat and source of fire. Keep in tightly closed container. Storage: Freeze -20C. Short term shipping may be at room temperature. Heat Sensitive.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: Not 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 the substance is apparent and engineering controls are not feasible, consult an industrial hygienist. For emergencies, or instances where the exposure levels are not known, use a full-face piece positive-pressure, air-supplied respirator. WARNING: Air purifying respirators do not protect workers in oxygen-deficient atmospheres.
Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as appropriate, to prevent skin contact.
Eye Protection: Use chemical safety goggles and/or a full face shield where splashing 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: Yellow crystalline solid.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting Point: 185C to 195C literature.
Initial boiling point and boiling range: 476C literature.
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: Practically insoluble in water.
Viscosity: Not available.
Molecular Weight: 312.44
Chemical Formula: C17H20N4S.
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Toxic fumes, sulfur oxides, nitrogen oxide, carbon dioxide and carbon monoxide may be formed in fire.
Hazardous Polymerization: Not reported.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flames, moisture, light, ignition sources and incompatibles.
11. Toxicological Information
Oral rat LD50: LD50 Oral Rat: 177 mg/kg.
Dermal rabbit: LD50 Dermal - Rabbit - > 200 mg/kg
Carcinogenicity: Not reported as carcinogen by any agency. No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC.
Reproductive Toxicity: No information available.
Developmental Effects: No information available.
Teratogenicity: No information available.
12. Ecological Information
Persistence and Degradability: No information available.
Bioaccumulation/ Accumulation: No information available.
Mobility: No information available.
Results of PBT and vPvB assessment: No information available.
Environmental Toxicity: No information available.
13. Disposal Considerations
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 container and unused contents in accordance with law.
14. Transport Information
DOT USA & ADR/RID Europe
UN Number: UN 2811
Proper shipping name: TOXIC SOLID, ORGANIC, N.O.S. (OLANZAPINE)
Class: 6.1, Packing group: III.
IMDG & IATA
UN Number: UN 2811
Proper shipping name: TOXIC SOLID, ORGANIC, N.O.S. (OLANZAPINE)
Class: 6.1, Packing group: III.
15. Regulatory Information
USA:
SARA 311/312: Acute & Chronic. See section 2.
California Prop 65: Not applicable.
Section 16 - Additional Information
European Labeling in Accordance with EC Directives:
H301: Toxic if swallowed
H315: Causes skin irritation.
H317: May cause an allergic skin reaction
H319: Causes serious eye irritation.
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbol:
T Toxic
Xi Irritant
Risk Phrase:
R25 Toxic if swallowed
R36/38 Irritating to eyes and skin
R43 May cause sensitization by skin contact.
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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