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Excipient / ICH-Q7 GMP Manufactured Product 
Urea, USP, EP, LBLE*, GMP, Excipient Grade

*Low Bioburden, Low Endotoxin 

Product Code: UREA-3250  

CAS #: 57-13-6
Formula: CH4N2O
Sol. In H2O (g/L): 480 @ 20˚C
F.W.: 60.06 g/mol
pH @ 20°C: 7.2 (10% soln.)

Minimum Order Quantity: 500kg | Lead Time (if no stock): 3 months | Package Sizes: 10kg, 25kg and 50kg pails. 

Specifications
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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 re-purified, GMP Urea in its FDA registered US facility.

General Product Description:

  • The manufacturing of Bio Excipient Grade UREA-3250 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 powder.
  • Molecular Formula: CH4N2O
  • Molecular Weight: 60.06 g/mol.
  • CAS #: 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-3250 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: Urea, Carbamide, Carbonyldiamide

Product Statements:

  • RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirement and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.

GMP Compliance:

  • Bio Excipient Grade Urea, UREA-3250 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 and 25kg pails and 50kg drums.