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

Supplier, Manufacturer, Exporter of Ketoconazole USP BP Ph Eur EP IP JP 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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Ketoconazole CAS Number 65277-42-1, EINECS EC Number: 265-667-4, Molecular Formula: C26H28Cl2N4O4, Molecular Weight: 531.43, HS Code 29349990

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

Ketoconazole is an antiandrogen, antifungal, and antiglucocorticoid medication used to treat several fungal infections.

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%
Packaging and Storage: Preserve in well-closed containers.

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.

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.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Ketoconazole SDS Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 23-Sept-24

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
Molecular Weight: 531.43
Chemical Formula: C26H28Cl2N4O4
Relevant uses and uses advised against (if any): 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 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.
P264: Wash ... thoroughly after handling.
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.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents/container in accordance with local/regional/national/international regulations.

Classification according to EU Directives 67/548/EEC or 1999/45/EC:
Hazard Symbols:
T Toxic
Risk Phrase:
R25 Toxic if swallowed
R62 Possible risk of impaired fertility.
R48 Danger of serious damage to health by prolonged exposure.

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. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse.
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. Cold water may be used. 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.). 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:
Small Spill: Mop and pick up the material and place in an appropriate waste disposal container. Soak up with inert absorbent material and dispose of it as hazardous waste. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: 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. 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. 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 contact with skin and eyes. 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 as low as possible. Local exhaust ventilation is preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details.
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. For emergencies, or instances where the exposure levels are not known, use a full-face piece positive-pressure, air-supplied respirator. WARNING: Air purifying respirators do not protect workers in oxygen-deficient atmospheres.
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. Wash hands after handling.

Appearance: White to Almost white powder to crystal.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
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: 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: Soluble in methanol.
Viscosity: Not available.
Molecular Weight: 531.43
Chemical Formula: C26H28Cl2N4O4

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: Not available.
Reproductive Effects: May damage fertility. Presumed human reproductive toxicant.

Toxicity to fish: Not available.
Persistence and Degradability: Not available.
Mobility: Not available.
Bioaccumulation/ Accumulation: 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. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused contents in accordance with federal, state, and local requirements.

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.

USA:
SARA 311/312 Hazards: Acute Health Hazard, Chronic Health Hazard. See section 2.

European Labeling in Accordance with EC Directives:
H301 Toxic if swallowed.
H360F May damage fertility.
H373 May cause damage to organs through prolonged or repeated exposure.

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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