Dextran Sulfate Na 8000 GMP

GMP Process Chemical

IPEC GMP Manufactured Product

Dextran Sulfate Sodium Salt, MW 8,000

LBLE*, GMP
Product Code: DXSE-4250

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 10kg
Lead Time (if no stock): 6-12 months (depends upon RM supply)

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For additional MW Dextran and Dextran Sulfate Polymers, Click Here

Product Code: DXSE-4250

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

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 bonds 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 which are intended for use in a final drug product. Dextran is soluble in water, easily filtered and biodegradable.

CAS #: 9011-18-1
Formula: (C₆H₇Na₃O₁₄S₃)n
M.W.: 8,000
pH (1%): 5.0 – 7.5

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance

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%

Manganese

< = 1ppm

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)

0.018 – 0.032

Sulfur

17 - 20%

Printable Version

Key Product Features:

The manufacturing of Dextran Sulfate 8000 Na, DXSE-4250 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

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:

10kg, 25kg and 50kg pails.

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.