Product Category

GMP Process Chemical

GMP Manufactured Product

GMP Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: DXSE-4250 | Previously: DS4250

Intended for Use in Pharmaceutical GMP Processes

Dextran Sulfate 8000 Na 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 8000 Na, 8000 MW 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.

Product Specifications




Off White to light yellow powder

Clarity (20% solution) Absorbance at 360nm


≤ 0.9 OD unit



≤ 1000 ppm


≤ 0.012 EU/mg

Free Sulfate


≤ 0.2%


35 - 48%

Identification (colorimetric)


Passes Test

Insoluble Iron

≤ 2%

Loss on Drying  ≤ 10%
Manganese (As Reported) ≤1ppm

pH (1% Solution)

5.0 to 7.5

Residue on Ignition

35 - 50%


≤ 2%

Specific Rotation [α]D20

+75° to 105°

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

0.018 – 0.032

Total Bioburden



 17 - 20%
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
IPEC cGMP Compliant Manufactured  
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.


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General Product Description:

  • The manufacturing of Dextran Sulfate 8000 Na, DXSE-4250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of DXSE-4250 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
  • Dextran Sulfate 8000 Na is an off white to light yellow powder
  • Molecular Formula: (C6H7Na3O14S3)n
  • Molecular Weight: 8000 g/mol.
  • CAS Number: 9011-18-1
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Dextran Sulfate 8000 Na, DXSE-4250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Dextran Sulfate 8000 Na manufactured at BioSpectra and any raw materials used in the manufacture of Dextran Sulfate 8000 Na at BioSpectra are not subject to genetic modification.
  • Synonyms: Dextran, Hydrogen Sulfate, Sodium Salt

GMP Compliance:

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.

Retest Date

The recommended expiration period for Dextran Sulfate 8000 Na is two years from the date of manufacture.

Storage and Shipping Conditions:

Store at Room Temperature

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information