Itraconazole IP EP JP USP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Itraconazole IP EP JP 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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Itraconazole CAS Number 84625-61-6, EINECS EC Number: 283-347-2, Molecular Formula: C35H38Cl2N8O4, Molecular Weight: 705.64, HS Code 29349990 or 29349900

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

Itraconazole is a medication used in the management and treatment of fungal infections. It is in the antifungal class of drugs.

General Properties and Specifications of Itraconazole:
Appearance: White to almost white powder or crystals.
Assay: >99%
Relative Density: 1.27
Melting Point: 165C-170C literature.
Boiling Point: 850C predicted.
Solubility: Practically insoluble in water.
Storage: 2C to 8C. Ok to freeze. Protect from light. Heat Sensitive.

Itraconazole USP Grade Specifications:
C35H38Cl2N8O4 --- 705.63
3H -1,2,4-Triazol-3-one, 4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)-;
(±)-1-sec-Butyl-4-[p-[4-[p-[[(2R *,4S *)-2-(2,4-dichlorophenyl)-2-(1H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one CAS 84625-61-6
UNII: 304NUG5GF4

DEFINITION
Itraconazole contains NLT 98.5% and NMT 101.5% of C35H38Cl2N8O4 calculated on the dried basis.

Residue on Ignition: NMT 0.1%, determined on 1.0 g.
Organic Impurities: To pass the test by chromatography.
Optical Rotation, Angular Rotation:
Sample: 100 mg/mL in methylene chloride.
Acceptance criteria: −0.10° to +0.10° at 20C.
Loss on Drying: Dry 1 g at 105C for 4 h: it loses NMT 0.5% of its weight.
Packaging and Storage: Preserve in tight, light-resistant containers, and store at room temperature.

Itraconazole BP Ph Eur Grade Specifications:
C35H38Cl2N8O4 --- 706 CAS 84625-61-6
Action and use: Antifungal.

DEFINITION
4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, very slightly soluble in ethanol (96 per cent).

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.

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Itraconazole SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 28-Aug-24

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.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Acute 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, H335

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.

Product Name & Other Names: Itraconazole.
CAS No.: 84625-61-6
EINECS EC Number: 283-347-2

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.

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.

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.

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.

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.

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 Reactivity

Stability: 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.

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.

Persistence and Degradability: No information available.
Mobility: 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. Dispose of containers and unused material in accordance with legal requirements.

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

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.

European Labeling in Accordance with EC Directives:
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
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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