Dextran Sulfate Sodium Salt, MW 40,000, GMP

Excipient

ICH Q7 GMP Manufactured Product

DEXTRAN SULFATE SODIUM SALT, MW 40,000

BET*, GMP
Product Code: DSX4-3250

*Bioburden and Endotoxin Tested

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Lead Time: Inquire

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Product Code: DSX4-3250

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Dextran Sulfate Sodium Salt, MW 40,000, 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 bonds and 5% or less of 1-3 branching. Dextran Sulfate Sodium Salt, MW 40,000 is used in the solubilization and purification process of protein molecules which are intended for use in a final drug product. Dextran is soluble in water, easily filtered and biodegradable.

Formula: [C₆H₇Na₃O₁₄S₃]_n
M.W.: 40,000 g/mol
CAS #: 9011-18-1

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

Off White to Light Yellow Powder

Absorbance (20%)

360nm

< = 0.9 OD unit

Chloride

< = 1000 ppm

Endotoxin

< = 0.012 EU/mg

Free Inorganic Sulfate

< = 0.2%

Glucose

35 - 48%

Identification, Colorimetric

Passes Test

Insoluble Iron

< = 2%

Loss on Drying

< = 10%

Microbial Content

TAMC

TYMC

< 50 CFU/g

pH (1%)

5.0 - 7.5

Residue on Ignition

35 - 50%

Pyridine

< = 2%

Specific Rotation, 20°C

+75° to 105°

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

0.05 - 0.13

Sulfur

17 - 20%

Printable Version

Key Product Features:

The manufacturing of Dextran Sulfate Sodium Salt, MW 40,000, is performed at BioSpectra's Bangor, PA facility.
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 animal parts, animal products and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: Dextran, Hydrogen Sulfate, Sodium Salt

Storage & Shipping:

Refer to SDS.

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).

Package Sizes:

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.