Pharmaceutical Excipient Grade Stearic Acid (95% Purity)
Pharmaceutical Excipient Grade Stearic Acid (95% Purity)
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Pharmaceutical Excipient Grade Stearic Acid (95% Purity)

Price
MOQ
$3.95
1000 Pieces
Product Details
Purity:
95.0% min
Melting Point:
70-71℃
Acid Value:
208-212 mg KOH/g
Shipping & Policy
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Payment Methods:
T/T PayPal
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Product Description
Company Info

Basic Info

This pharmaceutical-grade stearic acid is a regulatory-compliant excipient designed for use in oral solid dosage forms and topical pharmaceutical products. It acts as a lubricant to reduce friction during tablet pressing and capsule filling, solving common manufacturing pain points like sticking to molds and inconsistent tablet hardness. It serves generic drug manufacturers, branded pharmaceutical companies and contract development and manufacturing organizations (CDMOs).

Key attributes

Purity
95.0% min
Melting Point
70-71℃
Acid Value
208-212 mg KOH/g
Iodine Value
≤0.8 g I2/100g
Moisture
≤0.15%
Ash Content
≤0.05%
Heavy Metals
≤5 ppm
Residual Solvent
≤0.01%
Certifications
USP, EP, BP compliant
Packaging
25 Kilograms per aluminum foil bag
Shelf Life
36 months
Purity
95.0% min
Melting Point
70-71℃
Acid Value
208-212 mg KOH/g
Iodine Value
≤0.8 g I2/100g
Moisture
≤0.15%
Ash Content
≤0.05%
Heavy Metals
≤5 ppm
Residual Solvent
≤0.01%
Certifications
USP, EP, BP compliant
Packaging
25 Kilograms per aluminum foil bag
Shelf Life
36 months

Customer reviews

Dr. Lisa Williams · Pharmaceutical Research Scientist
The pharmaceutical excipient-grade stearic acid (95% purity) exceeds pharmacopeia standards for our tablet formulations. Its high purity ensures batch-to-batch consistency in drug release profiles. We particularly appreciate its excellent compressibility and lubricating properties in direct compression tableting. The material's low heavy metal content and microbiological quality meet our strict GMP requirements. It has significantly improved our tablet production efficiency while maintaining rigorous quality standards.

Product Description

Product features:

Produced via multiple recrystallization and purification processes, this product meets the strict purity standards of the United States Pharmacopeia (USP), European Pharmacopoeia (EP) and British Pharmacopoeia (BP). Its heavy metal levels are 50% below the maximum allowed limits in global pharmaceutical standards, with no detectable residual solvents that could impact drug stability. The uniform fine particle size ensures even distribution throughout pharmaceutical formulations, improving production yield and product consistency.

https://globalsyt.oss-accelerate.aliyuncs.com/materials/264/0/20260320112626_69bcbe621ed44.png

Product specifications:

This product appears as a white, fine powder with an average particle size of 150 mesh and a melting point of 70-71℃. It is packaged in food-grade aluminum foil bags enclosed in rigid cardboard drums for maximum protection against moisture and contamination. It must be stored in a cool, dry environment with controlled humidity, and complies with ICH Q7a Good Manufacturing Practice guidelines for pharmaceutical excipients.

https://globalsyt.oss-accelerate.aliyuncs.com/materials/264/0/20260320112620_69bcbe5cb4438.png

Product application:

It is primarily used as a lubricant in tablet and capsule manufacturing to reduce sticking to press molds and improve the surface finish of finished dosage forms. It also acts as a thickening agent for topical ointments and creams, adjusting the texture and spreadability of skincare and pharmaceutical topical products. Target customers include oral solid dosage manufacturers, topical pharmaceutical producers and CDMO facilities.

Frequently Asked Questions (FAQ)

Q:What are the USP/EP compliance requirements for pharmaceutical excipient-grade stearic acid (95% purity)?
A:Pharma-grade stearic acid must pass USP/EP testing for heavy metals (<10ppm), microbial limits (<100 CFU/g), and precise melting point (69-71°C). It's used in tablet coatings and capsule formulations under GMP conditions.

Company Profile

Business Type:
Manufacturer
Main Products:
polyethylene wax,stearic acid,paraffin,Fischer-Tropsch wax
Year of Establishment:
2015
Number of Employees:
11-50 People
Address:
Room 701, 7th Floor, Renxiang Building, No. 369, East Second Ring Road, Yuhua District, Shijiazhuang City, Hebei Province, Shijiazhuang, Hebei, China
Average Response Time:
14 Days

General Information

Business Type:
Manufacturer
Main Products:
polyethylene wax,stearic acid,paraffin,Fischer-Tropsch wax
Year of Establishment:
2015
Number of Employees:
11-50 People
Management System Certification:
TL900,OHSAS18001,QS9000,ISO9001,ISO9004,ISO14000,ISO16949
Address:
Room 701, 7th Floor, Renxiang Building, No. 369, East Second Ring Road, Yuhua District, Shijiazhuang City, Hebei Province, Shijiazhuang, Hebei, China

Trade Capability

Main Markets:
南美洲,东南亚,非洲,西欧,南欧,南亚
Shipping Ports:
Export Volume:
US$1.5 Million-US$2.5 Million
Average Lead Time:
14 Days
Payment Terms:
T/T L/C MoneyGram PayPal D/P Western Union Others
Cooperation Mode:
OEM ODM
Customization Supported:
No
Number of Foreign Trade Sales Staff:
11-50 People
Overseas Agent / Overseas Branch:
No

Company Show

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