LubriSanaq® Sodium Stearyl Fumarate

Identification & Functionality

Chemical Name

Sodium Stearyl Fumarate

Pharma & Nutraceuticals Functions

Lubricant

CAS No.

4070-80-8

EC No.

223-781-1

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Base Fluids, Glidants & Lubricants

Features & Benefits

Product Highlights

• Designed to accelerate product development in particluarly for high-speed direct compression of tablets.
• Superior tablet hardness at eqvivalent compession force
• Lower injection force at eqvivalent compression force
• Less impact on disintegration times

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules,

Tablets

Manufacturing Technology

Direct Compression

Applications

• Designed for formulations in which other lubricants (i.e. Mg Stearate) lead to formulation and/or manufacturing challenges examples in effervescent tablets or granules solutions

Properties

Physical Form

Powder,

Solid

Physico-Chemical Properties

	Value	Units	Test Method / Conditions
Saponification Value	142.20 – 146.00	—	—

Composition

	Value	Units	Test Method / Conditions
Water	max. 50	%	Ph. Eur / USP-NF
Sodium Stearyl Maleate	max. 0.25	%	USP-NF
Stearyl Alcohol	max. 0.5	%	USP-NF
Lead	max. 0.001	%	USP-NF
Heavy Metals	max. 0.002	%	USP-NF
Assay	99.00 - 101.50	%	Ph. Eur / USP-NF
Acetone	max. 300	ppm	USP-NF
Ethyl Acetate	max. 300	ppm	USP-NF
Toluene	max. 300	ppm	USP-NF
Methanol	max. 300	ppm	USP-NF
Related Substances Any Impurity	max. 0.5	%	Ph. EUR
Total Impurities	max. 0.5	%	Ph. EUR

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

National Formulary (NF),

United States Pharmacopeia (USP)

Chemical Inventories

EINECS (EU)

Grade

Pharma Grade