DEXTRAN POWDER, MW 10,000

Excipient

ICH-Q7 GMP Manufactured Product

DEXTRAN POWDER, MW 10,000

GMP, Excipient Grade
Product Code: D010-3201

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

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For additional MW Dextran and Dextran Sulfate Polymers, Click Here

Product Code: D010-3201

Intended for Use as an Intermediate (substrate) or Excipient in downstream parenteral drug applications.

GMP, Excipient Grade of Dextran, 10,000 MW is a more refined and purified version of hydrolyzed, higher molecular weight Dextran Polymer (Powders). Dextran Powder, MW 10,000 is a glucose polymer made by the fermentation of sugar by the Leuconostroc Mesenteroides bacteria. 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
M.W.: 10000 g/mol
CAS #: 9004-54-0

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance (Color)

White to slightly off-white powder

Ash Content

≤ 2.0%

Chloride

≤ 1%

Cold Water Solubility (1% Solution)

Passes Test

Color of Solution (10%)

375 nm

≤ 0.20 OD Units

Heavy Metals (as Pb)

≤ 20 ppm

Intrinsic Viscosity (1% Solution) @ 37°C

0.08 - 0.11

Loss on Drying

≤ 7.0%

pH (10% solution)

4.5 - 7.0

Specific Rotation (2% Solution) @ 20°C

≥ +148°

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General Product Description:

Our Dextran Powers are produced, refined and purified at our plant in Scarborough, Ontario, Canada and then further purified under full cGMP at our FDA Registered, GMP plant in Bangor, PA, USA.

Storage and Shipping Conditions:

Refer to SDS.

Standard Shelf Life Policy:

Each Certificate of Analysis will contain a 2-year retest/recertification date supported by a 3-year ICH Q7 Stability Study (if one is completed).

Package Sizes:

5, 10, 25 and 50kg Poly Pails with Poly Liner.

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.