Product Category

GMP Solution

ICH-Q7 GMP Manufactured Product

Urea 6M, GMP Excipient Grade

Made With USP/EP Grade Urea And Water For Injection

Product Code: UREA-3120

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.

Product Specifications



Appearance Colorless Liquid
Identification (IR)  
Conforms to Standard
5.8 – 6.2 M
pH @ 25°C  
7 - 10
Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

 ≤ 5 ppm

≤ 5 ppm

≤ 5 ppm

≤ 5 ppm 


MANUFACTURING STATEMENT: Manufactured using Urea raw material purified (in process) to Meet USP/EP compendial specifications.

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UREA-2220 | UR2220

CAS #: 57-13-6

Formula: CH4N2O
360 grams per Liter Urea
pH of a 6M soln., 25°C = 7-10

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:

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

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.

Additional Packaging Information