Specifications, Uses, SDS of Ketoconazole Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Ketoconazole IP BP Ph Eur EP JP USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 65277-42-1.
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 Ketoconazole IP BP Ph Eur EP JP USP 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.

Ketoconazole is an antiandrogen, antifungal, and antiglucocorticoid medication used to treat several fungal infections. It works by killing the fungus or yeast or preventing its growth.

Ketoconazole BP Ph Eur Grade Specifications:
C26H28Cl2N4O4 -- 531.4 CAS 65277-42-1
Action and use: Antifungal.

DEFINITION
1-Acetyl-4-[4-[[(2RS,4SR)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
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, soluble in methanol, sparingly soluble in ethanol (96 per cent).

IDENTIFICATION
First identification: B
Second identification: A, C, D
A. Melting point: 148C to 152C.
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography
D. To about 30 mg in a porcelain crucible add 0.3 g of anhydrous sodium carbonate. Heat over an open flame for 10 min. Allow to cool. Take up the residue with 5 mL of dilute nitric acid and filter. To 1 mL of the filtrate add 1 mL of water. The solution gives reaction of chlorides.

TESTS
Solution S:
Dissolve 1.0 g in methylene chloride and dilute to 10 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Optical rotation: -0.10° to + 0.10°, determined on solution S.
Related substances: To pass the test by Liquid chromatography.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Storage: Protected from light.

Ketoconazole USP Grade Specifications:
C26H28Cl2N4O4 --- 531.43
Piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis-;
(±)-cis-1-Acetyl-4-(p-[[2-(2,4-dichlorophenyl)-2-(imidazol-1- ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl)piperazine
CAS 65277-42-1
UNII: R9400W927I

DEFINITION
Ketoconazole contains NLT 98.0% and NMT 102.0% of ketoconazole (C26H28Cl2N4O4), calculated on the dried 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 system.
Optical Rotation, Specific Rotation:
Sample solution: 40 mg/mL in methanol
Acceptance criteria: −1° to +1° at 20C.
Loss on Drying: Dry under vacuum at 80C for 4 h. Acceptance criteria: NMT 0.5%

Ketoconazole SDS Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 12-April-25

Product Name & Other Names: Ketoconazole or (±)-cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
CAS No.: 65277-42-1
EINECS EC Code: 265-667-4
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 3), H301
Reproductive toxicity, (Category 1B), H360
Specific target organ toxicity - repeated exposure (Category 2) Blood, H373

Hazard Statements:
H301 Toxic if swallowed.
H360F May damage fertility.
H373 May cause damage to organs through prolonged or repeated exposure.

Precautionary Statements
P202: Do not handle until all safety precautions have been read and understood.
P220: Keep/Store away from clothing/other combustible materials.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
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.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P337+P313: If eye irritation persists: Get medical advice/ attention.

Inhalation: If is inhaled, it will cause irritation and damage to the nose and throat. It can cause headaches, bleeding from nose coughing and chest discomfort. Remove the victim to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: It will cause irritation and burns to mouth, digestive tract and stomach. It may lead to pain, nausea, vomiting, and even collapse. 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. Get medical attention.
Eye Contact: It can cause severe damage to eyes. Check for and remove any contact lenses. Immediately flush your eyes with running water for at least 15 minutes, keeping eyelids open. Get medical attention.

Toxic fumes, carbon dioxide, carbon monoxide, chlorine compounds, and nitrogen oxides may be formed in fire.
Fire Extinguishing Media: Dry chemical, foam or carbon dioxide and water spray jet. Avoid solid water jet.
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:
Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Avoid mist formation. Wear full protective equipment and ensure proper ventilation. Keep away from heat. Keep away from sources of ignition. Provide ventilation. Vacuum or sweep up and remove to an approved disposal container. Contact Environment Agency.

Precautions for safe handling: Keep away from heat and source of fire, preferably in a ventilated area. 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. 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. Keep locked up in tightly closed container. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Do not ingest. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents etc. Containers may be hazardous when empty since they retain product residues. Do not store near food items. Storage: Refrigerated (0-10C). Ok to freeze. Protected 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: A system of local and/or general exhaust is recommended to keep employee exposures low.
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.
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.

Appearance: White to Almost white powder to crystal.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: about 1.4
Melting point/freezing point: 148C to 152C literature.
Initial boiling point and boiling range: about 753C predicted.
Flash point: 88C.
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: Soluble in methanol.
Viscosity: No data found.

Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, nitrogen oxides (NOx), chlorine compounds, and toxic fumes may form when heated to decomposition.
Hazardous Polymerization: Not reported.
Incompatibilities: Oxidizing agents.
Conditions to Avoid: Heat, flames, ignition sources and incompatibles.

4-HOUR EXPOSURE.
Acute oral toxicity (LD50): 166 mg/kg Rat.
Carcinogenicity: Not available.
Mutagenic Effects: Suspected of causing genetic defects.
Developmental Toxicity: No data found.
Reproductive Effects: May damage fertility. Presumed human reproductive toxicant.

Toxicity to fish: No data found.
Persistence and Degradability: No data found.
Mobility: No data found.
Bioaccumulation/ Accumulation: 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.

DOT USA, TDG Canada & ADR/RID Europe
UN Number: 2811
Proper shipping name: Toxic solids, organic, n.o.s. (Ketoconazole).
Class: 6.1, Packing group: III.
IMDG & IATA
UN Number: 2811
Proper shipping name: Toxic solids, organic, n.o.s. (Ketoconazole).
Class: 6.1, Packing group: III.

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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Ketoconazole 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 Ketoconazole IP BP Ph Eur EP JP USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 65277-42-1.

Ketoconazole Manufacturers, Suppliers, Exporters, Wholesalers: