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Sodium Stearyl Fumarate
Sodium Stearyl Fumarate

Sodium Stearyl Fumarate

MOQ : 50 Kilograms

Sodium Stearyl Fumarate Specification

  • Ingredients
  • Sodium Stearyl Fumarate
  • Appearance
  • White to off-white fine powder
  • Structural Formula
  • CH(COONa)=CHCOOR, where R = C17H35
  • Purity
  • > 98%
  • Density
  • 0.37 Gram per cubic centimeter(g/cm3)
  • Storage
  • Store in a cool, dry place, tightly closed container, protected from moisture
  • Solubility
  • Practically insoluble in water, soluble in ethanol
  • Application
  • Used as a tablet lubricant in pharmaceutical formulations
  • Grade
  • Pharma Grade
  • Product Type
  • Pharmaceutical Excipient
  • Melting Point
  • >230C (decomposes)
  • Smell
  • Odorless
  • CAS No
  • 4070-80-8
  • Properties
  • Highly compressible, acts as a lubricant in tablet formulations, chemically stable, non-toxic
  • Poisonous
  • NO
  • Shape
  • Fine powder
  • EINECS No
  • 223-773-0
  • Physical Form
  • Powder
  • Molecular Formula
  • C22H41NaO4
  • HS Code
  • 29171990
  • Usage
  • Pharmaceutical tablets, especially for direct compression method
  • Shelf Life
  • 24 months
  • Molecular Weight
  • 392.54 g/mol
  • Taste
  • Odorless, tasteless
  • Ph Level
  • 6.5 - 8.5 (1% solution)
  • Loss on Drying
  • Not more than 4.0%
  • Storage Temperature
  • Below 25C
  • Bulk Density
  • 0.25 to 0.50 g/cm
  • Manufacturing Method
  • Esterification of stearyl alcohol with fumaric acid followed by saponification
  • Particle Size
  • 90% below 100 m
  • Allergen Information
  • Free from allergens
  • Packaging Type
  • HDPE drums or fiber drums with double polythene liners
  • Heavy Metals
  • Not more than 20 ppm
  • Compliance/Standard
  • USP/NF, Ph. Eur.
  • Microbial Limit
  • Total aerobic microbial count NMT 100 cfu/g
 

Sodium Stearyl Fumarate Trade Information

  • Minimum Order Quantity
  • 50 Kilograms
  • Supply Ability
  • 1 Kilograms Per Week
  • Delivery Time
  • 1 Week
 

About Sodium Stearyl Fumarate

Sodium Stearyl Fumarate Properties:
  • PubChem CID : 23665634
  • Molecular Formula : C22H39NaO4
  • Molecular Weight : 390.5 g/mol
  • CAS No : 4070-80-8
  • Synonyms : Pruv , SODIUM OCTADECYL FUMARATE, Sodium monostearyl fumarate, Sodium monooctadecyl fumarate

Sodium Stearyl Fumarate Computed Properties:

Property Name Property Value
Molecular Weight 390.5 g/mol
Hydrogen Bond Donor Count 0
Hydrogen Bond Acceptor Count 4
Rotatable Bond Count 20
Exact Mass 390.274604 g/mol
Monoisotopic Mass 390.274604 g/mol
Topological Polar Surface Area 66.4
Heavy Atom Count 27
Formal Charge 0
Complexity 369
Isotope Atom Count 0
Defined Atom Stereocenter Count 0
Undefined Atom Stereocenter Count 0
Defined Bond Stereocenter Count 1
Undefined Bond Stereocenter Count 0
Covalently-Bonded Unit Count 2
Compound Is Canonicalized Yes

 




Superior Performance Lubricant for Tablets

Sodium Stearyl Fumarate is widely recognized for its exceptional lubrication properties that enhance tablet manufacturing through direct compression. Its high compressibility facilitates smooth tablet production, reducing friction and preventing sticking during ejection. This results in efficient manufacturing and consistent tablet quality, making it a preferred choice in the pharmaceutical industry.


Chemically Stable and Allergen-Free

Manufactured under stringent quality controls, Sodium Stearyl Fumarate is chemically stable, non-toxic, and free from common allergens. Compliance with major pharmacopeias such as USP/NF and Ph. Eur. ensures safety and reliability. Its stability, low microbial count, and high purity make it suitable for sensitive pharmaceutical applications.


Safe Handling and Convenient Packaging

The product is shipped in secure HDPE or fiber drums with double polythene liners, minimizing contamination risk and moisture exposure. Its recommended storage is below 25C in cool, dry conditions. With a shelf life of 24 months, Sodium Stearyl Fumarate retains its efficacy and functionality when stored properly, ensuring reliable supply to manufacturers and suppliers.

FAQs of Sodium Stearyl Fumarate:


Q: What is Sodium Stearyl Fumarate and how is it used in pharmaceutical formulations?

A: Sodium Stearyl Fumarate is a highly compressible, non-toxic powder primarily used as a tablet lubricant in pharmaceutical formulations, especially for the direct compression method. It helps reduce friction and prevents tablets from sticking to manufacturing equipment.

Q: How is Sodium Stearyl Fumarate manufactured?

A: It is produced by esterification of stearyl alcohol with fumaric acid, followed by a saponification process. This method ensures high chemical stability and optimal purity.

Q: When should Sodium Stearyl Fumarate be used in tablet production?

A: It is particularly suitable for direct compression tablet manufacturing processes where superior lubrication and minimal metal contamination are essential.

Q: Where is Sodium Stearyl Fumarate typically stored and how should it be handled?

A: It should be stored in a tightly closed container in a cool, dry place, protected from moisture and at temperatures below 25C to maintain product stability and prevent degradation.

Q: What are the benefits of using Sodium Stearyl Fumarate in pharmaceutical tablets?

A: Using this excipient enhances tablet compressibility, ensures chemical stability throughout shelf life, and prevents sticking during production, leading to higher manufacturing efficiency and product consistency.

Q: Is Sodium Stearyl Fumarate safe and allergen-free for pharmaceutical use?

A: Yes, the product is non-toxic, odorless, tasteless, and free from allergens. It complies with USP/NF and Ph. Eur. standards and maintains low microbial and heavy metal limits, assuring safety in pharmaceuticals.

Q: What is the typical packaging and shelf life of Sodium Stearyl Fumarate?

A: It is supplied in HDPE or fiber drums with double polythene liners for optimal protection, and, when properly stored, has a shelf life of up to 24 months.

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