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GMP Biotech Product

DEXTRAN SULFATE SODIUM SALT, MW 8,000 BIOTECH

LBLE*, GMP

*Low Bioburden, Low Endotoxin

COAs Spec Sheet

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Product Code: DXSE-4252
Intended for Use in Biopharmaceutical, Biotechnological Applications and Products

Dextran Sulfate Sodium Salt, MW 8,000 is a polyanionic derivative of dextran, produced by the esterification of the glucose polymer (glucan polysaccharide) with chlorosulphonic acid. Dextran fractions are characterized by their average MW and MW distribution with predominantly 1-6 glycosidic bones and 5% or less of 1-3 branching. Each base dextran polymer has characteristics unique to the specific strain of bacteria from which is was derived. In addition to variables in molecular weight and branching, the level of sulfonation adds to the unique character and performance of the finished product in terms of its intended end use. Dextran Sulfate Sodium Salt, MW 8,000 is used in the solubilization and purification process of protein molecules intended for use in a final drug product. Dextran is neutral in pH and soluble in water. It is easily filtered and biodegradable.

Formula: (C6H7Na3O14S3)n
M.W.: 8000 g/mol
CAS #:
9011-18-1

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance (Color)  

Off White to Light Yellow

Appearance (Form)

 

Powder

Chloride Content

 

≤ 1000 ppm

DNase-Endo/Exonuclease

 Pass

DNase – Nickase

 

 Pass

Free Inorganic Sulfate

≤ 0.2 %

Glucose

35 - 48%

Identity (colorimetric)

 

Pass

Insoluble Iron

≤ 2.0 %

Loss on Drying

≤ 10.0%

Microbial Contamination

 ≤ 10 CFU/g

pH 1% aqueous

 5.0 - 7.5

Protease Detection

Pass

Residue on Ignition

 35 – 50%

Residue Pyridine

 ≤ 2.0%

Specific Rotation 20°C

 75 – 105°

Total Sulfur Content

 17.0 – 20.0%

UV Absorbance 360nm 20% aqueous

  ≤ 0.9 Abs UN

Viscosity 1.0M NaCl / 25°C

   0.018 – 0.032

 

Printable Version

General Product Description:

Molecular Formula: (C6H7Na3O14S3)n
Molecular Weight: 8000 g/mol
CAS Number: 9011-18-1

Dextran Sulfate Sodium Salt, MW 8,000 Biotech:

  • Appears as an off-white to light yellow powder
  • Is manufactured under an ICH-Q7 Quality Managed cGMP System
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Has no known major food allergens (as defined by FDA and WHO)
  • The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
  • Is not subject to genetic modification
  • Synonyms: Dextran Hydrogen Sulfate, Sodium Salt

Shelf Life Policy:

Three-year expiry from the date of manufacture.

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Size:

100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.