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Product Overview

Shea Butter is a natural, plant-derived lipid excipient obtained from the kernels of Vitellaria paradoxa. It is widely used in pharmaceutical, cosmetic, and nutraceutical formulations due to its excellent emollient, moisturizing, anti-inflammatory, and skin-protective properties. In pharmaceutical applications, Shea Butter is valued for topical, dermatological, and semi-solid dosage forms owing to its high biocompatibility and stability.

Product Type: Pharmaceutical Excipient

Chemical Name Shea Butter (Natural Triglycerides)
Chemical Formula Not applicable
CAS Number 91080-23-8
Molecular Weight Not applicable
Application Role Emollient & Skin Conditioning Agent,Ointment, Cream & Semi-solid Base
Regulatory Compliance Pharmacopoeial Alignment, US FDA
Manufacturing Suitability Topical Creams, Ointments & Semi-solid Formulations,Dermatological & Medicinal Skin Preparations,Emulsion-Based Systems (O/W and W/O),Suppositories & Rectal/Vaginal Bases (selected formulations),Lip Balms, Medicated Balms & Protective Pastes
Storage Conditions Store in a cool, dry place, away from direct sunlight and heat sources, Recommended storage temperature 15°C – 25°C
Certifications WHO-GMP compliant manufacturing; ISO 9001:2015 certified quality system
Availability Available in pharmaceutical and cosmetic grades, supplied as refined or unrefined Shea Butter
HS Code 1515.90

Excipient Technical Profile

Appearance Off-white to pale yellow solid fat
Bulk Density Not applicable
Solubility Insoluble in water; soluble in oils, fats, and most organic solvents
pH (1% w/v solution) Not applicable

Typical Applications

Key Benefits

Natural & Sustainable Origin
Anti-inflammatory & Soothing Effects
Excellent Skin Compatibility
Stable Semi-solid Base
Strong Moisturizing & Occlusive Properties
Wide Global Regulatory Acceptance

Safety Info

⚠️ Safety Information: PVP K 30 (Polyvinylpyrrolidone)

Toxicology & Safety Profile

  • Non-toxic and safe for topical use
  • Non-irritant and non-sensitizing
  • Suitable for sensitive skin and pediatric formulations
  • No known carcinogenic or mutagenic effects

Handling Precautions

  • Handle with clean equipment to avoid contamination
  • Avoid excessive heat exposure during processing
  • Use protective gloves during handling

Storage & Stability

  • Store in a cool, dry place, away from direct sunlight and heat sources
  • Recommended storage temperature: 15°C – 25°C
  • Keep containers tightly closed to prevent oxidation and contamination
  • Avoid exposure to moisture and humid environments
  • Do not subject material to repeated heating and cooling cycles, as this may affect texture and stability

Regulatory & Compliance

  • Pharmacopoeial Alignment: Confirms to Ph.Eur. requirements for vegetable fats and oils (where applicable)
  • Cosmetic Regulations: Compliant with EU Cosmetic Regulation (EC) No. 1223/2009
  • US FDA: Permitted for cosmetic, topical pharmaceutical, and food/nutraceutical applications as per intended use
  • GRAS Status: Generally Recognized as Safe for approved food and nutraceutical uses
  • REACH Compliance: REACH registered / exempt as a natural substance
  • GMP Compliance: Manufactured and packed in WHO-GMP compliant facilities
  • Quality System: ISO 9001:2015 certified quality management system
  • Global Acceptance: Suitable for export to US, EU, UK, LATAM, ASEAN, and MENA markets

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

Yes. Our Shea Butter meets quality and safety requirements for pharmaceutical topical and semi-solid formulations.

Yes. It complies with EU Cosmetic Regulation (EC) No. 1223/2009 and is accepted in global cosmetic markets.

Yes. It is 100% natural and derived from the kernels of Vitellaria paradoxa.

The standard shelf life is 24–36 months under recommended storage conditions.

Yes. It functions effectively in both oil-in-water (O/W) and water-in-oil (W/O) emulsions.

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 Shea Butter 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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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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