Dutasteride USP BP Ph Eur EP Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Dutasteride USP BP Ph Eur EP 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. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Dutasteride CAS Number 164656-23-9, EINECS EC Number: 638-758-5, Molecular Formula: C27H30F6N2O2, Molecular Weight: 528.54, HS Code 293790** or 291419** or 29420090
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SDS MSDS Sheet of Dutasteride Manufacturers
Dutasteride
USP BP Ph Eur EP Grade Suppliers
Dutasteride is a potent 5-alpha reductase inhibitor used to treat symptomatic benign prostatic hyperplasia (BPH/enlarged prostate) by reducing prostate volume, and off-label for male pattern hair loss.
General Properties and Specifications of Dutasteride:
Appearance: White to Light yellow powder or crystals.
Assay: 98% minimum.
Melting Point: 242C to 250C literature.
Solubility: Insoluble in water. Soluble in Chloroform, Ethanol, Methanol, Acetone.
Storage: Air Sensitive. Room Temperature (Recommended in a cool and dark place, <15C).
Dutasteride USP Grade Specifications:
C27H30F6N2O2 --- 528.53
(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide;
α,α,α,α′,α′,α-Hexafluoro-3-oxo-4-aza-5α-androst-1-ene-17β-carboxy-2′,5′-xylidide
CAS 164656-23-9
UNII: O0J6XJN02I
DEFINITION
Dutasteride contains NLT 97.0% and NMT 102.0% of dutasteride (C27H30F6N2O2), calculated on the anhydrous and solvent-free 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.
Assay: 97% to 102% on anhydrous and solvent-free basis.
Residue on Ignition: NMT 0.1%
Limit of Platinum: To pass the test. --- NMT 5 µg/g.
Organic Impurities, Procedure 1 & 2: To pass the test.
Water Determination: Sample: 100 mg. The Sample is heated in a tube at 180C for 4 min in a stream of dry inert gas. Acceptance criteria: NMT 0.50%
Optical Rotation, Procedures, Specific Rotation: Sample solution: 10 mg/mL in chloroform and alcohol (98:2). Acceptance criteria: +15.0° to +25.0°
Packaging and Storage: Preserve in tight containers, and store below 30C.
Dutasteride BP Ph Eur Grade:
C27H30F6N2O2 --- 528.5 CAS 164656-23-9
DEFINITION
N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide.
Content: 97.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or pale-yellow powder.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, soluble or sparingly soluble in anhydrous ethanol.
IDENTIFICATION
A. Specific optical rotation.
B. Infrared absorption spectrophotometry.
TESTS
Specific optical rotation: + 33.0 to + 39.0 (anhydrous substance). Dissolve 0.100 g in anhydrous ethanol and dilute to 20.0 mL with the same solvent.
Related substances: To pass the test by Liquid chromatography.
Water: Maximum 0.2 per cent, determined on 0.100 g using the evaporation technique at 180C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g in a platinum crucible.
Dutasteride EP Grade is also offered.
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.
We also manufacture and supply as under:
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +91-22-65290100, +91-22-65290101
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Last 9 May, 2026
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Dutasteride SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 09-May-26
1. Product Identification
Product Name & Other Names: Dutasteride.
CAS No.: 164656-23-9
EINECS Number: 638-758-5
Molecular Weight: 528.54
Chemical Formula: C27H30F6N2O2
Relevant uses and uses advised against (if any): Laboratory Chemicals and Industrial Manufacturing Use.
Supplier: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Carcinogenicity Category 2, H351
Reproductive toxicity Category 1A, H360
Labeling according to GHS & Regulation (EC) No 1272/2008
GHS Label Elements Health Hazard |
Signal Word: Danger
Hazard statements:
H351: Suspected of causing cancer.
H360: May damage fertility and unborn child.
Precautionary statements:
P202: Do not handle until all safety precautions have been read and understood.
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.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P285: In case of inadequate ventilation wear respiratory protection.
P330: Rinse mouth.
P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a comfortable position for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P405: Store locked up.
P501: Dispose of contents/container to authorized agents only.
Classification according to European Directive 67/548/EEC as amended:
Hazard Codes:
Xn Harmful
R-phrases:
R40 Limited evidence of a carcinogenic effect
R61 May cause harm to fertility and the unborn child.
3. Composition/Information on Ingredients
Product Name & Other Names: Dutasteride.
CAS No.: 164656-23-9
EINECS Number: 638-758-5
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: If inhaled, remove to fresh air. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Give large amounts of water to drink. Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Cold water may be used. Wash clothing & Shoes before reuse. Get medical attention.
Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention.
Notes to Physician: Treat symptomatically.
5. Fire Fighting Measures
Fire: Not expected to be a fire hazard. It may burn at high temperatures. Fire will produce irritating, poisonous, and corrosive gases. Runoff may pollute waterways.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemicals, or carbon dioxide. Use means suitable for extinguishing surrounding fire. Avoid solid water stream.
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. Do not allow run-off from firefighting to enter drains or water courses.
Decomposition Products: Acrid smoke, irritating or toxic and corrosive fumes (or gases), including fluorine compounds, nitrogen oxides, carbon monoxide and carbon dioxide.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Ventilate area of leak or spill. 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: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove it into an approved disposal container. Avoid inhalation, contact with skin, eyes, and clothing. Evacuate the area of all non-essential personnel. Use personal protective equipment. Avoid contact with skin, eyes, and clothing. Ensure adequate ventilation. Avoid dust formation. Sweep up (avoid generating dust) and using clean non-sparking tools transfer to a clean, suitable, clearly labeled container for disposal in accordance with local regulations.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Do not ingest. Use only with adequate ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling it. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust/mist/vapor generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. 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 containers. Keep air contact to a minimum. 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, strong acids, and bases. Under no circumstances eat, drink or smoke while handling this material. Storage: Air Sensitive. Room Temperature (Recommended in a cool and dark place, <15C).
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: Contains no substances with occupational exposure limit values.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to the substance is apparent, 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.
Hygiene Measures: When using, do not eat, drink, or smoke. Wash hands and face before breaks and immediately after handling the product.
Engineering Controls: Showers, Eyewash stations, Ventilation systems.
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.
9. Physical and Chemical Properties
Appearance: White to Light yellow powder or crystals.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: Not available.
Melting Point: 242C to 250C 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: Insoluble in water. Soluble in Chloroform, Ethanol, Methanol, Acetone.
Viscosity: Not available.
Molecular Weight: 528.54
Chemical Formula: C27H30F6N2O2
10. Stability and Reactivity
Stability: Stable under recommended conditions of use and storage. Air sensitive.
Hazardous Decomposition Products: Fluorine compounds, nitrogen oxides, carbon dioxide and carbon monoxide may form when heated to decomposition. Toxic fumes may be released when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents and strong acids and bases.
Conditions to Avoid: Incompatibles. Direct sunlight. Extremely high or low temperatures.
11. Toxicological Information
Acute toxicity: Not available.
Carcinogenicity: Suspected of causing cancer. Limited evidence of a carcinogenic effect.
Reproductive toxicity: May damage fertility and the unborn child.
Germ cell mutagenicity: Not available.
Teratogenicity: Not available.
12. Ecological Information
Toxicity to fish: Not available.
Mobility: Not available.
Persistence and Degradability Not available.
Results of PBT and vPvB assessment: Not available.
13. Disposal Considerations
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.
14. Transport Information
DOT USA: Not regulated
IMDG & IATA: Not regulated
ADR/RID Europe: Not regulated.
15. Regulatory Information
USA:
Section 313: Not subject to the reporting requirements of the Act.
SARA Section 311/312 Hazard Classes: Delayed (chronic) health hazard. See section 2.
Section 16 - Additional Information
European Labeling in Accordance with EC Directives:
H351: Suspected of causing cancer.
H360: May damage fertility and the unborn child.
Classification according to European Directive 67/548/EEC as amended:
Hazard Codes:
Xn Harmful
R-phrases:
R40 Limited evidence of a carcinogenic effect
R61 May cause harm to fertility and the unborn child.
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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