Description

Sodium Stearyl Fumarate is a high-purity, white to off-white powder widely recognized as a superior tablet and capsule lubricant in pharmaceutical manufacturing. Its primary value lies in its exceptional flow properties and minimal interference with tablet disintegration and drug dissolution, making it a critical excipient for ensuring production efficiency and product performance. This compound is essential for formulators and manufacturers in the pharmaceutical industry seeking reliable, compliant excipients for solid oral dosage forms, including tablets and capsules.

Application

• Primary lubricant in the direct compression and wet granulation processes for pharmaceutical tablets.
• Flow aid and anti-adherent in capsule filling operations to ensure smooth manufacturing.
• Key excipient in the formulation of nutraceutical and dietary supplement tablets.
• Used in the production of effervescent tablets where compatibility with acidic components is required.
• Lubricant of choice for formulations sensitive to the negative effects of magnesium stearate on dissolution.
• Applicable in the development of controlled-release and immediate-release solid dosage forms.

Basic Information

Product Name	Sodium Stearyl Fumarate
CAS No.	4070-80-8
Molecular Formula	C22H39NaO4
Molecular Weight	390.53 g/mol
Synonyms	Stearyl Fumarate Sodium Salt; Octadecyl Fumarate Sodium Salt; SSF; Fumaric Acid, Stearyl Ester, Sodium Salt; Sodium Octadecyl Fumarate; E 486; INS 486; Pruv® (Trade Name)
EINECS	223-772-2

Quality Control

Our Sodium Stearyl Fumarate is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards, including USP-NF and Ph. Eur. monographs where applicable. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and physical specifications, ensuring compliance for pharmaceutical and nutraceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to protect from atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white, fine powder
Identification (IR)	Conforms
Assay (on dried basis)	98.0 - 102.0 %
Loss on Drying	≤ 5.0 %
Residue on Ignition	14.0 - 16.0 %
Heavy Metals	≤ 10 ppm
Microbial Enumeration Tests	Meets Ph. Eur./USP requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.