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Intended For Use As An Excipient

• Urea is used in biochemistry and molecular biology 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 in its FDA registered, US facility.

General Product Description:

• The manufacturing of Urea UREA-3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
• Urea is a White Crystalline product.
• Molecular Formula: CH4N2O
• Molecular Weight: 60.06 g/mol.
• 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 UREA-3220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
• Urea manufactured at BioSpectra and any raw materials used in the manufacture of Urea at BioSpectra are not subject to genetic modification.
• Synonyms: Carbamide, Carbonyldiamide.

GMP Compliance:

• Bio Excipient Grade Urea, UREA-3220 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Urea is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

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

Storage and Shipping Conditions:

• Ship and Store between 15˚ and 30˚C.
• Store in clean and dry area.
• Store in the original container.

Package Sizes:

• 10kg, 25kg and 50kg pails.