Stearic Acid

Product Overview

Stearic acid is a saturated long chain fatty acid.It is naturally occurring substance found in various animals and plants fats.It is pharmacologically inactive substance that serves as a medium for a drug or API.

Product Type: Pharmaceutical Excipient

Chemical Name Octadecanoic acid

Chemical Formula C₁₈H₃₆O₂

CAS Number 57-11-4

Molecular Weight 284.48 g/mol

Application Role Lubricant in tablet and capsule manufacturing, Glidant to improve powder flow, Binder to enhance tablet cohesion

Regulatory Compliance FDA

Manufacturing Suitability Stable under normal processing conditions, Compatible with a wide range of active pharmaceutical ingredients, Easy to handle and incorporate into formulations

Storage Conditions Store in a cool, dry place, Keep container tightly closed to avoid moisture uptake

Certifications FDA GRAS, GMP (depending on manufacturer)

Availability Widely available globally from multiple suppliers, Sourced from both animal (tallow) and vegetable (coconut, palm oil) origins

HS Code 2915.70

Excipient Technical Profile

Appearance white, waxy, or flaky solid

Bulk Density 0.7 to 0.9 g/cm³

Solubility Practically insoluble in water, Soluble in organic solvents such as ethanol, ether, chloroform, and benzene

Typical Applications

Used in creams, lotions, and soaps for thickening and stabilizing formulations.
Acts as a lubricant and emulsifier for smooth texture.
Manufacture of candles, plastics, and rubber as a softening agent
Lubricant in tablet and capsule formulations to aid in manufacturing and ejection

Key Benefits

Excellent Lubrication

Non-Toxic and Safe

Improves Flowability

Chemical Stability

Enhances Tablet Hardness

Compatibility

Safety Info

⚠️ Stearic Acid-Safety Information

Toxicological Profile

Generally regarded as safe (GRAS) for pharmaceutical, food, and cosmetic applications.
Low acute toxicity with no significant harmful effects when used at typical excipient levels.

Sensitization and Allergic Reactions

May cause mild irritation to eyes and skin upon direct contact in concentrated form.
Handling in powder form may cause minor respiratory irritation if inhaled in large quantities.

Environmental Impact

Biodegradable and poses low environmental risk when disposed of properly

Handling Precautions

Use appropriate personal protective equipment (PPE) such as gloves and safety glasses during handling.
Avoid inhalation of dust by using dust masks or working in well-ventilated areas.

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.

FAQs

Yes, it is commonly used as a thickener and emulsifier in creams, ointments, and lotions.

It meets USP, EP, and JP pharmacopeial standards and is approved by major regulatory bodies like FDA and EMA.

It is compatible with most APIs but should be tested for specific interactions during formulation development.

It usually ranges from 0.5% to 5% w/w depending on the formulation requirements.

Yes, stearic acid is classified as GRAS (Generally Recognized as Safe) by the FDA and is widely used in food, pharmaceuticals, and cosmetics.

You can request a product catalogue or custom quotation by contacting us at export@saliuspharma.com or through the inquiry form submitted on our website. Our export team responds to all inquiries 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:

High-purity Stearic Acid
Packaged for maximum stability and protection
Moisture-resistant, tamper-evident sealing

✔ Custom Packaging Options:

Tailored drum sizes, blister packs, or bottle formats
Designed to meet your operational needs and dosage requirements

Place an Order or Request a Quote from Salius Pharma

Looking to source Stearic Acid 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.

Get in Touch

Email: export@saliuspharma.com
Call / WhatsApp: +91 84258 80640 / +91 84258 80643
Landline: +91 22 49700 601 / +91 22 44503 148
Corporate Office: 3104–3106, Plan S Business Park, Nerul MIDC Opp. Dr. D.Y. Patil Stadium, Navi Mumbai – 400706, Maharashtra, India

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