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Sodium Stearyl Fumarate

Name: Sodium Stearyl Fumarate
Brand: A. B. ENTERPRISES

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MOQ : 50 Kilograms

Sodium Stearyl Fumarate Specification

Ph Level
6.5 - 8.5 (1% solution)

Product Type
Pharmaceutical Excipient

Density
0.37 Gram per cubic centimeter(g/cm3)

Purity
> 98%

Shelf Life
24 months

Melting Point
>230°C (decomposes)

Ingredients
Sodium Stearyl Fumarate

Solubility
Practically insoluble in water, soluble in ethanol

EINECS No
223-773-0

Poisonous
NO

CAS No
4070-80-8

HS Code
29171990

Grade
Pharma Grade

Structural Formula
CH(COONa)=CHCOOR, where R = C17H35

Appearance
White to off-white fine powder

Smell
Odorless

Molecular Formula
C22H41NaO4

Taste
Odorless, tasteless

Application
Used as a tablet lubricant in pharmaceutical formulations

Usage
Pharmaceutical tablets, especially for direct compression method

Physical Form
Powder

Properties
Highly compressible, acts as a lubricant in tablet formulations, chemically stable, non-toxic

Molecular Weight
392.54 g/mol

Shape
Fine powder

Storage
Store in a cool, dry place, tightly closed container, protected from moisture

Allergen Information
Free from allergens

Particle Size
90% below 100 m

Compliance/Standard
USP/NF, Ph. Eur.

Manufacturing Method
Esterification of stearyl alcohol with fumaric acid followed by saponification

Packaging Type
HDPE drums or fiber drums with double polythene liners

Microbial Limit
Total aerobic microbial count NMT 100 cfu/g

Loss on Drying
Not more than 4.0%

Storage Temperature
Below 25C

Heavy Metals
Not more than 20 ppm

Bulk Density
0.25 to 0.50 g/cm3

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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