Product Category

GMP Process Chemical

GMP Manufactured Product

DEXTRAN SULFATE 8000 Na,
LBLE,
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

ANALYSIS

SPECIFICATIONS

Appearance  

Off White to light yellow powder

Clarity (20% solution) Absorbance at 360nm

 

NMT 0.9 OD unit

Chloride Content

 

NMT 1000 ppm

Free Inorganic Sulphate

 

NMT 0.2%

Glucose Content

35% - 48%

Identity

 

To Pass Test

Insoluble Iron

NMT 2.0%

Loss on Drying  NMT 10.0%

pH (1% Solution)

5.0 to 7.5

Residue on Ignition

35% - 50%

Residual Pyridine

NMT 2.0%

Specific Rotation [α]D20

+75° to 105°

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

0.018 – 0.032

TAMC

TYMC

<100CFU/g

<100CFU/g

Total Sulphur Content

 17.0% - 20.0%
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
IPEC cGMP Compliant Manufactured  
Yes-image
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image

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.

 

List of C of As files
No files available right now.

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

formula-image
formula-image

DXSE-3250

CAS #: 9011-18-1

Formula:

(C6H7Na3O14S3)n

M.W.: 8000 g/mol

pH @ 20°C: 5.0 – 7.5

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

https://www.biospectra.us/technical/packaging