Dextran Sulfate Sodium Salt Biotech, GMP

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.

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.: 8,000 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

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

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 and 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.