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GMP Biotech Product

DEXTRAN SULFATE SODIUM SALT, MW 8,000 BIOTECH

Low Bioburden, GMP
Product Code: DXSE-4252

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Product Code: DXSE-4252
Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

This is a high purity, reagent grade product, purified under cGMP conditions. Dextran Sulfate Sodium Salt, MW 8,000, is a polyanionic derivative of dextran, produced by the esterification of the glucose polymer (glucan polysaccharide) with chlorosulfonic 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. 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 soluble in water, easily filtered and biodegradable.

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

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color  

Off White to Light Yellow Powder

Chloride

 

< = 1000 ppm

Absorbance (20%)

360 nm

< = 0.9 OD Unit

Enzymes

DNase - NICKase

DNase - Exonuclease

Protease

None Detected

None Detected

None Detected

Free Inorganic Sulfate

< = 0.2 %

Glucose

35 - 48%

Identification, Colorimetric

 

Passes Test

Insoluble Iron

< = 2.0 %

Loss on Drying

< = 10.0%

Microbial Content

TAMC

TYMC

< = 10 CFU/g

< = 10 CFU/g

pH (1%)

 5.0 - 7.5

Residue on Ignition

 35 – 50%

Pyridine

< = 2.0%

Specific Rotation, 20°C

 +75° – +105°

Sulfur

 17.0 – 20.0%

Specific Viscosity (In 1.0M NaCl, 25°C)

   0.018 – 0.032

 

Printable Version

Key Product Features:

  • Appears as an off-white to light yellow powder
  • Manufactured in accordance with IPEC
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Contains 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:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS. 

Package Sizes:

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.