Calcium Stearate

Product Overview

Calcium Stearate is a versatile pharmaceutical excipient used as a lubricant in solid dosage forms such as tablets and capsules. It is a calcium salt of stearic acid and also acts as a stabilizer, emulsifier, and suspending agent in various formulations.

Product Type: Pharmaceutical Excipient

Chemical Name Calcium Octadecanoate

Chemical Formula C₃₆H₇₀CaO₄

CAS Number 1592-23-0

Molecular Weight ~607.02 g/mol

Application Role Lubricant, anti-adherent, flow agent, release agent in solid oral dosage forms

Regulatory Compliance IP / BP / USP / EP

Manufacturing Suitability Compatible with direct compression and dry granulation; suitable for high-speed tablet presses and encapsulation machines

Storage Conditions Store in a cool, dry place; keep container tightly closed; protect from moisture and excessive heat

Certifications cGMP, ISO

Availability Readily available from Salius Pharma; supplied in powder form

HS Code 29157090

Excipient Technical Profile

Appearance White to off-white free-flowing powder

Bulk Density 0.4 – 0.7 g/cm³

Solubility Insoluble in water; sparingly soluble in alcohol; soluble in hot oils, fats, and organic solvents such as benzene, chloroform, and ether

Typical Applications

Used as a lubricant to reduce friction during tablet compression and capsule filling
Improves powder flow properties in dry granulation and direct compression
Helps tablets release cleanly from molds and machinery
Used in vitamin and mineral tablets and capsules

Key Benefits

Effective lubricant

Moisture resistance

Anti-adherent properties

Non-toxic and safe

Improves powder flow

Safety Info

Calcium Stearate – Safety Information

Toxicity

Generally recognized as non-toxic and safe for use in pharmaceuticals and food
Oral LD50 in rats reported to be greater than 5,000 mg/kg, indicating low acute toxicity

Handling Precautions

Avoid inhalation of dust during manufacturing to prevent respiratory irritation
Use appropriate PPE such as masks and gloves in powder handling areas
Not classified as hazardous under OSHA or GHS criteria

Environmental Impact

Biodegradable and considered environmentally safe

Allergenicity

No known allergenic effects reported

Overdose / Toxicity

No significant adverse effects expected at typical excipient levels used in drug formulations

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. At high concentrations, it may retard disintegration and dissolution due to its hydrophobic nature. Levels are usually kept below 2% w/w.

Yes. It is widely used in direct compression, but blending time should be controlled to avoid over-lubrication.

Generally no, but caution is advised with acidic APIs due to its alkaline nature. Compatibility testing is recommended.

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

It is not ideal due to insolubility in water and potential to slow disintegration. Water-soluble lubricants are preferred.

You can contact export@saliuspharma.com or submit an inquiry through the website Visit On www.saliusapi.com 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:

High-purity Calcium Stearate
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 Calcium Stearate 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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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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