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Product Overview

Acetone is an organic solvent used in the pharmaceutical industry. It is also used in formulation and manufacturing processes in topical products and drug delivery systems. The primary role of acetone is to dissolve APIs during formulation, particularly in topical preparations and aerosol sprays.

Product Type: Pharmaceutical Excipient

Chemical Name Acetone (Propanone)
Chemical Formula C₃H₆O
CAS Number 67-64-1
Molecular Weight 58.08 g/mol
Application Role Volatile organic solvent used as a processing aid in pharmaceutical formulations for dissolving APIs and excipients, particularly in topical products, aerosol sprays, and tablet coatings
Regulatory Compliance IP / BP / USP
Manufacturing Suitability Suitable for use as a solvent in pharmaceutical manufacturing processes; evaporates quickly leaving minimal residue; flammable and requires controlled handling
Storage Conditions Store in tightly closed containers, in a cool, dry, well-ventilated area away from ignition sources and heat
Certifications Typically available with CoA, CoO, and compliance certificates for pharmaceutical or technical grade solvents
Availability Widely available globally in bulk drums and smaller packaging
HS Code 29141100

Excipient Technical Profile

Appearance Clear, colorless, volatile liquid
Density (20°C) 0.784 – 0.791 g/cm³
Solubility Miscible with water and common organic solvents such as ethanol, methanol, ether, and chloroform; slightly to moderately soluble in oils
pH of aqueous solution Around 6.0 – 7.0

Typical Applications

Key Benefits

Excellent solvent properties
Low toxicity at residual levels
Rapid evaporation
Cost-effective and widely available
Wide solubility range
Compatible with many processes

Safety Info

⚠️Safety Information: Acetone

Hazard Classification

  • Flammable Liquid – Category 2
  • Eye Irritation – Category 2A
  • Specific Target Organ Toxicity (Single Exposure) – Category 3 (narcotic effects)
  • UN Number: 1090 (Acetone)

Health Hazards

  • Inhalation may cause dizziness, drowsiness, headache, or respiratory irritation
  • Skin contact may cause dryness or irritation with prolonged exposure
  • Eye contact causes moderate to severe irritation
  • Ingestion may cause gastrointestinal discomfort if swallowed in large quantities

Fire & Explosion Hazards

  • Highly flammable liquid and vapor
  • Vapors can form explosive mixtures with air
  • Keep away from heat, sparks, open flames, and hot surfaces

Exposure Limits

  • OSHA PEL: 1000 ppm (TWA)
  • NIOSH REL: 250 ppm (TWA)

Why Choose Salius Pharma?

  • GMP-Compliant Quality: Stringent QC to ensure consistent, premium-grade excipients.
  • Regulatory Support: Comprehensive documentation available.
  • Reliable Supply: Global distribution with timely delivery.
  • Technical Expertise: Dedicated formulation support and customer service.
  • Customized Solutions: Flexible packaging and product grades tailored to your needs.
Documents We Provide

FAQs

Typically 2 to 3 years when stored properly in sealed containers, away from light, heat, and ignition sources. Always refer to the manufacturer’s CoA for exact shelf life.

Residual acetone is tested using Gas Chromatography (GC) as per USP <467> or ICH Q3C guidelines.

No. Acetone is not suitable for direct use in sterile or injectable formulations due to toxicity risks and incomplete removal concerns.

Yes. COA, MSDS, DMF, Stability Data, COS, Impurity Profile, BA/BE Studies, and WHO-GMP/ISO certificates are available upon request.

Acetone evaporates completely when used properly; any trace amounts must remain below regulatory limits.

You can contact export@saliuspharma.com or submit an inquiry through the website Visit On www.saliusapi.com The export team responds within 24–48 hours.

What You Receive with Every Order

At Salius Pharma, we deliver more than just an excipient — we deliver confidence, compliance, and quality. Every shipment is thoughtfully prepared to meet international regulatory standards and your exact specifications.

What’s Included:

✔ Premium Product:
✔ Custom Packaging Options:

Place an Order or Request a Quote from Salius Pharma

Looking to source Acetone or other high-quality pharmaceutical products?
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Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

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