Spironolactone USP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Spironolactone, 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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Spironolactone CAS Number 52-01-7, EINECS EC Number: 200-133-6, Molecular Formula: C24H32O4S, Molecular Weight: 416.60, HS Code 29420090

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

For SDS MSDS Sheet Click
SDS MSDS Sheet of Spironolactone Manufacturers

Pure USP BP Ph Eur Grade Suppliers

Spironolactone is primarily used to treat fluid build-up due to heart failure, liver scarring, or kidney disease. It is also used in the treatment of high blood pressure, low blood potassium that does not improve with supplementation, early puberty in boys, acne and excessive hair growth in women.

General Properties and Specifications of Spironolactone:
Appearance: White powder.
Assay: 98% minimum.
Melting point: 207C to 208 C literature.
Boiling point: about 597C (Predicted).
Solubility: Negligibly Soluble in water.
Storage: 2C to 8C (Refrigeration).

Spironolactone USP Grade Specifications:
C24H32O4S -- 416.57
Pregn-4-ene-21-carboxylic acid, 7-(acetylthio)-17-hydroxy-3-oxo-, 𝛾-lactone, (7α,17α)-;
17-Hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid 𝛾-lactone acetate CAS 52-01-7
UNII: 27O7W4T232

Spironolactone contains NLT 97.0% and NMT 103.0% of C24H32O4S, calculated on the dried basis.

A. Infrared Absorption
B. Ultraviolet Absorption
Sample solution: Add 100 mg to a mixture of 10 mL of water and 2 mL of 1 N sodium hydroxide.
Analysis: Boil the mixture for 3 min, cool, and add 1 mL of glacial acetic acid and 1 mL of lead acetate.
Acceptance criteria: A brown-to-black precipitate of lead sulfide is formed.
Limit of Mercapto Compounds:
Sample solution: Shake 2.0 g with 30 mL of water, and filter.
Analysis: To 15 mL of the filtrate add 3 mL of starch and titrate with 0.010 N iodine. Perform a blank determination and make any necessary correction.
Acceptance criteria: NMT 0.10 mL of 0.010 N iodine is consumed.
Optical Rotation, Specific Rotation: −41° to −45°
Loss on Drying: Dry a sample at 105C for 2 h: it loses NMT 0.5% of its weight.

Spironolactone BP Ph Eur Grade Specifications:
C24H32O4S -- 416.6 CAS 52-01-7
Action and use: Aldosterone receptor antagonist; potassium-sparing diuretic.

Content: 97.5 per cent to 102.0 per cent (dried substance).

Appearance: White or yellowish-white powder.
Solubility: Practically insoluble in water, soluble in ethanol (96 per cent).

First identification: A
Second identification: B, C
A. Infrared absorption spectrophotometry.
B. Thin-layer chromatography.
C. To about 10 mg add 2 mL of a 50 per cent V/V solution of sulfuric acid and shake. An orange solution with an intense yellowish-green fluorescence is produced. Heat the solution gently; the colour becomes deep red and hydrogen sulfide, which blackens lead acetate paper is evolved. Add the solution to 10 mL of water; a greenish-yellow solution is produced, showing opalescence or a precipitate.

Specific optical rotation: -41 to -46 (dried substance).
Related substances: To pass the test.
Chromium: Maximum 50 ppm.
Loss on drying: Maximum 0.5 per cent, determined on 1 g by drying in an oven at 105C for 3 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1 g.

For Original Monographs of IP Indian 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:

Calcium Bromo Lactobionate




Lactobionic Acid


Sodium Lactobionate


Y-Butyrolactone or Gamma-Butyrolactone or GBL

Piroctone Olamine or 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2(1H)-pyridone Ethanolammonium Salt.


Ambernath Mumbai, Ankleshwar Gujarat, India
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Last 17 May, 2024

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Spironolactone SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet

1. Product Identification

Product Name & Other Names: Spironolactone.
CAS No.: 52-01-7
EINECS Number: 200-133-6
Molecular Weight: 416.60
Chemical Formula: C24H32O4S
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, H360D
Specific target organ toxicity - repeated exposure Category 2, H373

Labeling according to GHS & Regulation (EC) No 1272/2008

GHS Label Elements
Health Hazard
Health Hazard

Signal Word: Danger

Hazard statements:
H351: Suspected of causing cancer.
H360D: May damage the unborn child. 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.
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.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable 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
R40 Limited evidence of a carcinogenic effect
R48/22 Harmful: danger of serious damage to health by prolonged exposure if swallowed
R61 May cause harm to the unborn child.

3. Composition/Information on Ingredients

Product Name & Other Names: Spironolactone.
CAS No.: 52-01-7
EINECS Number: 200-133-6

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 your 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 temperature. Fire will produce irritating, poisonous, and corrosive gases. Runoff may pollute waterways.
Fire Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical, 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 lead or lead oxides, acetic acid, 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 to 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. 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 container. 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. Under no circumstances eat, drink or smoke while handling this material. Storage: 2C to 8C.

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 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. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

9. Physical and Chemical Properties

Appearance: White powder.
Odor: Unpleasant.
Odor threshold: Not available.
pH: Not available.
Relative density: around 1.13.
Boiling Point: about 597C (Predicted).
Melting Point: 207C to 208 C literature.
Flash point: 120C.
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: Negligibly Soluble in water.
Viscosity: Not available.
Molecular Weight: 416.60
Chemical Formula: C24H32O4S

10. Stability and Reactivity

Stability: Stable under ordinary conditions of use and storage. Air and moisture sensitive.
Hazardous Decomposition Products: Lead oxide, carbon dioxide and carbon monoxide may form when heated to decomposition. Toxic fumes of the contained metal may be released when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents.
Conditions to Avoid: Incompatibles. Direct sunlight. Extremely high or low temperatures.

11. Toxicological Information

Acute toxicity: LD50 Oral (Rat): 4121 mg/kg.
Carcinogenicity: Suspected of causing cancer. Limited evidence of a carcinogenic effect.
Reproductive toxicity: May damage the unborn child. May damage fertility.
Germ cell mutagenicity: Not available.
Teratogenicity: Not available.
May cause damage to organs through prolonged or repeated exposure.

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

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 the unborn child.
H373: May cause damage to organs through prolonged or repeated exposure.

Classification according to European Directive 67/548/EEC as amended:
Hazard Codes:
Xn Harmful
R40 Limited evidence of a carcinogenic effect
R48/22 Harmful: danger of serious damage to health by prolonged exposure if swallowed
R61 May cause harm to the unborn child.

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.