+91 84258 80640 export@saliuspharma.com

Product Overview

Dibutyl phthalate is a phthalate ester commonly used as a plasticizer in pharmaceutical formulations. It is also used in topical, oral, and transdermal drug products to improve the mechanical properties of dosage forms. It is a functional excipient with established utility in pharmaceutical coatings and controlled-release systems.

Product Type: Pharmaceutical Excipient

Chemical Name Dibutyl Phthalate
Chemical Formula C₁₆H₂₂O₄
CAS Number 84-74-2
Molecular Weight 278.35 g/mol
Application Role Plasticizer in film coatings; occasionally used in capsule shell formulations
Regulatory Compliance BP / USP
Manufacturing Suitability Suitable for coating formulations and controlled-release technologies; compatible with hydrophilic and hydrophobic polymers
Storage Conditions Store in tightly closed, light-resistant containers; keep in cool, dry conditions; avoid exposure to heat, light, and oxidizing agents
Certifications FDA GRAS, GMP (depending on manufacturer)
Availability Commercially available in bulk quantities through chemical and excipient suppliers; sold under various brand and trade names
HS Code 2917.39.00

Excipient Technical Profile

Appearance Colorless to faint yellow liquid
Density 1.045 – 1.050 g/cm³
Solubility Insoluble in water; soluble in ethanol

Typical Applications

Key Benefits

Excellent plasticizing efficiency
Processability enhancement
Improves drug release control
Solubility in organic solvents
Compatibility with a wide range of polymers
Cost-effective

Safety Info

Dibutyl Phthalate – Safety Information

Toxicological Profile

  • Non-toxic when used within recommended pharmaceutical concentrations
  • Considered safe for use as an excipient in approved formulations
  • Not systemically absorbed and largely passes through the gastrointestinal tract unchanged

Inhalation Risk

  • May cause mild respiratory irritation if inhaled as aerosol or mist
  • Use appropriate ventilation and fume extraction during handling
  • Precautions apply mainly during preparation of coating solutions

Skin and Eye Contact

  • Generally non-irritating to skin
  • May cause mild mechanical irritation to eyes; rinse immediately with clean water
  • Avoid prolonged skin contact to prevent defatting or irritation

Handling Precautions

  • Use PPE such as gloves, chemical splash goggles, and lab coats
  • Ensure adequate ventilation or use fume hoods
  • Avoid ingestion, inhalation of vapors, and direct contact with skin or eyes

Environmental Impact

  • Not expected to pose significant environmental risks under normal pharmaceutical use
  • Biodegradable over time
  • Generally non-toxic to aquatic life at standard concentrations; avoid large-scale spills

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

Quality is ensured through in-house QA/QC systems, GLP-compliant laboratories, batch-to-batch consistency, validated testing methods, and compliance with ICH/WHO GMP standards.

Yes. Contract manufacturing and technology transfer services are offered globally, with experience across multiple countries.

Yes. Support includes CTD/eCTD dossier preparation, DMF filing, and responses to regulatory authority queries.

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

Supplied to over 40 countries including the USA, Germany, UK, Brazil, UAE, South Africa, Canada, and Southeast Asia.

You can contact export@saliuspharma.com or submit an inquiry through the website. Responses are provided 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 Dibutyl Phthalate or other high-quality pharmaceutical products?
We’re here to help.
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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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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