Intended For Use As An Excipient Grade Solution 

• Urea is used as a protein denaturant with low UV absorptivity. In addition to increasing solubility of hydrophobic molecules, unfolding proteins and altering their three-dimensional structures, Urea also renatures protein structures. BioSpectra manufactures repurified, GMP Urea. This multi-compendial certified Urea crystal is combined with WFI grade water to manufacture the finished 6M Urea Solution.

General Product Description:

The manufacturing of Bio Excipient Grade Urea 6M soln.,
UREA-3120 is performed at BioSpectra’s Bangor, PA facility and is conducted in a multi-purpose processing area using multi-purpose equipment.

• Urea 6M solution is a colorless liquid.
• Molecular Formula: CH4N2O
• Molecular Weight: 60.06 g/mol.
• 6M solution: 360 g/liter
• pH: 7-10
• CAS Number: 57-13-6.
• There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
• BioSpectra certifies that all Urea 6M solution, UREA-3120 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
• Urea 6M solution manufactured at BioSpectra and any raw materials used in the manufacture of Urea at BioSpectra are not subject to genetic modification.
• Manufactured with WFI water.
• Synonyms: Carbamide Solution, Carbonyl Diamide Solution

GMP Compliance:

• Bio Excipient Grade Urea 6M solution, UREA-3120 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Urea 6M solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

• The recommended retest period for Urea 6M solution is two years from the date of manufacture.

Storage and Shipping Conditions:

• Store in a tightly closed container. Store in dry, well-ventilated area with temperature between 15-30° C. Store away from incompatible substances.

Package Sizes:

• 200 Liter drums, 1,000 – 1,200 L totes.