ICH-Q7 GMP Manufactured Product
*Low Bioburden, Low Endotoxin
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.
CAS #: 9011-18-1
Formula: (C6H7Na3O14S3)n
M.W.: 8000 g/mol
pH @ 20°C: 5.0 – 7.5
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ANALYSIS |
SPECIFICATIONS |
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Off White to light yellow powder |
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≤ 0.9 OD unit |
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≤ 1000 ppm |
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Endotoxin |
≤ 0.012 EU/mg |
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≤ 0.2% |
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Glucose |
35 - 48% |
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Passes Test |
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Insoluble Iron |
≤ 2% |
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| Loss on Drying | ≤ 10% | ||
| Manganese (As Reported) | ≤1ppm | ||
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pH (1% Solution) |
5.0 to 7.5 |
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Residue on Ignition |
35 - 50% |
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Pyridine |
≤ 2% |
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Specific Rotation [α]D20 |
+75° to 105° |
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Specific Viscosity (In 1.0M NaCl at 25°C) |
0.018 – 0.032 |
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Total Bioburden |
≤100CFU/g |
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Sulfur |
17 - 20% |
Printable Version
Bio Pharma Grade Dextran Sulfate 8000 Na, DXSE-4250 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of Dextran Sulfate 8000 Na is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
The recommended expiration period for Dextran Sulfate 8000 Na is two years from the date of manufacture.
Store at Room Temperature
10kg, 25kg and 50kg pails.
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.