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cGMP, GLP - FDA Approved, ISO 9001, ISO 14001, ISO 17025, ISO 45001, HACCP, FSSC 22000, FSSAI, "REACH" Registered, Kosher & Halal Certified. We observe WHO Good Manufacturing Practice GMP and Good Laboratory Practice GLP
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for Active Substance to be imported into European Union (EU).Itraconazole SDS of Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Itraconazole 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.
Itraconazole Specifications of Manufacturers
Synonyms: Itraconazole
CAS Number: 84625-61-6, Molecular Weight: 705.64, Chemical Formula: C35H38Cl2N8O4, EINECS EC Number: 283-347-2, FEMA: ----,Itraconazole SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 18-Sept-241. Product Identification
Product Name & Other Names: Itraconazole.
CAS No.: 84625-61-6
EINECS EC Number: 283-347-2
Molecular Weight: 705.64
Chemical Formula: C35H38Cl2N8O4
Relevant uses and uses advised against (if any): Research 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 1272/2008Acute toxicity, oral Category 4, H302
Skin corrosion/irritation Category 2, H315
Serious eye damage/eye irritation Category 2A, H319
Specific target organ toxicity, single exposure; Respiratory tract irritation Category 3, H335Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements
IrritantSignal Words: Warning
Hazard statements:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.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.
P332+313: If skin irritation occurs: Get medical advice/attention.
P337+P313 If eye irritation persists: Get medical advice/ attention.
P501: Dispose of contents/container to authorized agents only.Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
Xi Irritant.
Xn Harmful.
Risk Phrases:
R22: Harmful if swallowed.
R36/37/38: Irritating to eyes, respiratory system & skin.3. Composition/Information on Ingredients
Product Name & Other Names: Itraconazole.
CAS No.: 84625-61-6
EINECS EC Number: 283-347-24. First Aid Measures
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.5. Fire Fighting Measures
Fire: May become a fire hazard at high temperatures.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Avoid solid water jet.
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx), Hydrochloric acid, Chlorine compounds and Toxic fumes.
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.6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Use personal protective equipment. Avoid dust formation. 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: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.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.). 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 oxidizing agents. Avoid dust formation and control ignition sources. Containers may be hazardous when empty. Storage: 2C to 8C. Ok to freeze. Protect from light. Heat Sensitive.8. Exposure Controls/Personal Protection
Airborne Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: In general, dilution ventilation is a satisfactory health hazard control for this substance. However, if conditions of use create discomfort, a local exhaust 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. 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.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.9. Physical and Chemical Properties
Appearance: White to almost white powder or crystals.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: 1.27
Boiling Point: 850C predicted.
Melting Point: 165C-170C 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: 705.64
Chemical Formula: C35H38Cl2N8O4
10. Stability and ReactivityStability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Nitrogen & Carbon oxides, Hydrochloric acid, Chlorine compounds and Toxic fumes.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Heat, flame, ignition sources, dusting, and incompatibles.11. Toxicological Information
LD50 Oral - Rat - >320 mg/kg.
Carcinogenic Effects: 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, NTP, ACGIH, OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.12. Ecological Information
Persistence and Degradability: No information available.
Mobility: No information available.
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. Processing use or contamination of this product may change the waste management options. Dispose of containers and unused material in accordance with legal requirements.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IATA/ICAO and IMDG/IMO: Not regulated.15. Regulatory Information
USA:
SARA 311/312 Hazardous Categorization: Acute Health Hazard as per section 2.
California Proposition 65: This product does not contain any Proposition 65 chemicals.16. Other Information
European Labeling in Accordance with EC Directives:
Classification according to EU Directives 67/548/EEC or 1999/45/EC:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
Hazard Symbols:
Xi Irritant.
Xn Harmful.
Risk Phrases:
R22: Harmful if swallowed.
R36/37/38: Irritating to eyes, respiratory system & skin.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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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, INDIAe-mail: info@anmol.org
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Last updated 18-sep-24Exporters 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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