Specifications, SDS of Fluconazole USP BP Ph Eur EP JP Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Fluconazole USP BP Ph Eur EP JP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 86386-73-4.
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 Fluconazole USP BP Ph Eur EP 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.

Fluconazole BP Ph Eur Grade Specifications:
C13H12F2N6O --- 306.3 CAS 86386-73-4
Action and use: Antifungal.

DEFINITION
2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol.
Content: 99.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, hygroscopic, crystalline powder.
Solubility: Slightly soluble in water, freely soluble in methanol, soluble in acetone.
It shows polymorphism.

TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 1.0 g in methanol and dilute to 20 mL with the same solvent.
Related substances: To pass the test by Liquid chromatography.
Storage: In an airtight container.

Fluconazole USP Grade Specifications:
C13H12F2N6O --- 306.27
1H -1,2,4-Triazole-1-ethanol, 1-(2,4-difluorophenyl)-1-(1H -1,2,4-triazol-1-ylmethyl)-;
2,4-Difluoro-1′,1′-bis(1H -1,2,4-triazol-1-ylmethyl)benzyl alcohol CAS 86386-73-4
UNII: 8VZV102JFY

DEFINITION
Fluconazole contains NLT 98.0% and NMT 102.0% of C13H12F2N6O, calculated on the dried basis.

Organic Impurities, Procedure 1: To pass the test by chromatography.
Organic Impurities, Procedure 2: To pass the test by chromatography.
Organic Impurities, Procedure 3: To pass the test by thin layer chromatography.
Residue on Ignition: NMT 0.1%
Iron: Acceptance criteria: NMT 20 ppm.
Loss on Drying: Dry a sample at 105C for 3 h: it loses NMT 0.5% of its weight.
Clarity and Color of Solution: Dissolve a sample in methanol to obtain a 5-in-100 solution (w/v). Acceptance criteria: The solution is clear and colorless.
Packaging and Storage: Preserve in tight containers, and store below 30C.

Fluconazole SDS, Safety Data Sheet MSDS Sheet, Material safety Data Sheet 27-March-25

Product Name & Other Names: Fluconazole.
CAS No.: 86386-73-4
EINECS: EC Number: 627-806-0
Relevant uses and uses advised against (if any): 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 irritation (Category 2), (H315)
Eye irritation (Category 2), (H319)
Specific target organ toxicity - single exposure Category 3, (H335)
Reproductive toxicity Category 1B, (H360)

Hazard statements:
H302 Harmful if swallowed.
H315 Causes skin irritation.
H319 Causes serious eye irritation.
H335 May cause respiratory irritation.
H360: May damage fertility. May damage the unborn child.

Precautionary statements:
P210: Keep away from heat/sparks/open flames/hot surfaces – No smoking.
P261 Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P270: Do not eat, drink, or smoke when using this product.
P280 Wear protective gloves/ eye protection/ face protection.
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Product Name & Other Names: Fluconazole.
CAS No.: 86386-73-4
EINECS: EC Number: 627-806-0

Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
Note to Physician: Symptomatic and supportive treatment is recommended.

Flammability of the Product: It is an organic combustible material.
Products of Combustion: It emits Carbon oxides, Nitrogen oxides, Fluorine compounds and fumes when heated to decomposition.
Fire Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. 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.

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.).
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Eliminate all sources of ignition. 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.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. 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. 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. Storage: Room Temperature. Recommended in a cool and dark place, <15C. Hygroscopic.

Airborne Exposure Limits: No adequate information found. Better keep it below 10 ppm.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator 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: No data found.
Boiling Point: 580C predicted.
Melting Point: 138C-140C 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 information found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Slightly soluble in water. Soluble in methanol.
Viscosity: No data found.

Stability: Stable under ordinary conditions of use and storage. Hygroscopic,
Hazardous Decomposition Products: It emits Carbon oxides, Nitrogen oxides, Fluorine compounds and fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents and Heat.
Conditions to Avoid: Moisture, Heat, Incompatibles.

Toxicity to Animals:
ORAL (LD50): 1271 mg/kg (Rat).
Carcinogenic Effects: Not a reported carcinogen.
Mutagenic Effects: No data found.
Teratogenic Effects: No data found.
Developmental Toxicity: May damage fertility. May damage the unborn child.

Environmental Toxicity: No information found.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

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

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

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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Fluconazole 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 Fluconazole USP BP Ph Eur EP JP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 86386-73-4.

Fluconazole Manufacturers, Suppliers, Exporters, Wholesalers: