Specifications, Uses, SDS of Itraconazole USP EP IP JP Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Itraconazole USP EP IP JP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 84625-61-6.
King of Chemicals has several associated companies having accreditations like cGMP, GLP - FDA Approved Good Manufacturing Practice and Good Laboratory Practice of WHO standard, ISO-9001, ISO-14001, ISO/IEC 17025, ISO ISO-45000, HACCP, FSSC 220000, FSSAI, "REACH" Registered, Kosher & Halal Certified. e-CTD and DMF support can be made available if needed. We offer USP NF BP Ph Eur EP IP JP Analytical Reagent FCC Food Grade Chemicals & Nutraceuticals.

Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Itraconazole USP EP IP JP Grade for actual users, including retail or small pack supplies for research and development work.

We supply fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals at best prices. We and/or our associated units have all the facilities to supply as per cGMP standard observing good manufacturing practice and good laboratory practice. We can assure low microbial count and also offer a test certificate for the same. We maintain warehouses across USA, India, and UAE. Our group exports to USA, Canada, Mexico, Argentina, Brazil, Chile, Korea, Malaysia, Thailand, Indonesia, Europe, and several other parts of the world. We supply in wholesale container loads to small pack of few grams. Solid products may be specified for it size and shape as desired by the buyer.

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

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).

Itraconazole SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 30-March-25

Product Name & Other Names: Itraconazole.
CAS No.: 84625-61-6
EINECS EC Number: 283-347-2
Relevant uses and uses advised against (if any): Research in Industrial Manufacturing.

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.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P270: Do not eat, drink or smoke when using this product.
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.

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. 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 as it can scatter the fire.
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.

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.).
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. 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.).
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 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.
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.
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.

Appearance: White to almost white powder or crystals.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: 1.27
Boiling Point: 850C predicted.
Melting Point: 165C-170C literature.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Practically insoluble in water.
Viscosity: No data found.

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: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.

Persistence and Degradability: No data found.
Mobility: No data found.
Results of PBT and vPvB assessment: No data found for assessment.

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Follow all the pollution control laws for disposal.

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

USA:
SARA 311/312 Hazardous Categorization: Acute health hazard. Irritant and Harmful.
California Proposition 65: Not listed to cause cancer,birth defects or reproductive harm.

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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Itraconazole Manufacturers, Suppliers, Exporters, Wholesalers:

Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-23774610, 91-22-23723564

If I give you “My Word” Nobody can undo it.
If I sign an “Agreement” my Lawyer will undo it

Our products are for industrial and laboratory use only. The user must test the material before use. We are not dispensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals.

Specifications, Properties, Uses, SDS of Itraconazole USP EP IP JP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 84625-61-6.

Itraconazole Manufacturers, Suppliers, Exporters, Wholesalers: