Active Pharmaceutical Ingredient

Sodium Stearyl Fumarate — CAS 4070-80-8

Also known as: SSF; Pruv

GMP Certified IP / BP / EP / USP Lubricant / Excipient Aurangabad, India
Sodium Stearyl Fumarate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sodium Stearyl Fumarate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 4070-80-8

Product Overview

Sodium Stearyl Fumarate (SSF) is a widely used pharmaceutical excipient primarily employed as a tablet lubricant. It functions by reducing friction during tablet compression, improving powder flow properties, and preventing sticking. Mediocon Inc manufactures GMP-compliant Sodium Stearyl Fumarate at its Aurangabad facility to international pharmacopoeial standards.

Therapeutic Applications
  • Tablet and capsule lubricant
  • Pharmaceutical excipient
  • Direct compression formulations
  • Modified-release dosage forms

Technical Specifications

ParameterSpecification
CAS Number4070-80-8
Molecular FormulaC₂₂H₃₉NaO₄
Molecular Weight406.52 g/mol
GradeIP / BP / EP / USP
CategoryLubricant / Excipient
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoSSF/25030247
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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