Dextran Powder, MW 10,000 GMP

Excipient

ICH Q7 GMP Manufactured Product

DEXTRAN POWDER, MW 10,000

GMP, Excipient
Product Code: D010-3201

Minimum Order Quantity: 50kg
Lead Time: 3-6 months

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For additional MW Dextran and Dextran Sulfate Polymers, Click Here

Product Code: D010-3201

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

Excipient Grade Dextran Powder, 10,000 MW, is a more refined and purified form of hydrolyzed, higher-molecular-weight Dextran polymer powder. Dextran Powder, MW 10,000 is a glucose polymer made by the fermentation of sugar by the bacteria Leuconostoc Mesenteroides. It is defined as a “branched poly-α-d-glucoside,” having predominant C-1 to C-6 bonds. Dextran polymers are freely soluble in water and other solvents, biodegradable and biocompatible, and have a wide range of applications in the Life Sciences.

Formula: [C₆H₁₀O₅]_n
M.W.: 10,000 g/mol
CAS #: 9004-54-0

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance (Color)

White to Slightly Off-White Powder

Chloride

< = 1%

Cold Water Solubility (1%)

Passes Test

Absorbance (10%)

375 nm

< = 0.20 OD Unit

Heavy Metals (Pb)

< = 20 ppm

Intrinsic Viscosity (1%), 37°C

0.08 - 0.11

Loss on Drying

< = 7.0%

pH (10%)

4.5 - 7.0

Residue on Ignition

< = 2.0%

Specific Rotation (2%), 20°C

> = +148°

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Key Product Features:

Our Dextran Powders are produced, refined and purified at our facility in Scarborough, Ontario, Canada, and then further purified at our FDA registered, cGMP plant in Bangor, PA, USA.
Appears as a white to slightly off-white powder
Manufactured in accordance with ICH Q7
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: 2,3,4,5-tetrahydroxy-6-[3,4,5-trihydroxy-6-[[3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-yl] oxymethyl] oxan-2-yl] oxyhexanal

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:

1kg, 5kg, 10kg, 25kg, and 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.