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.

Printable Version

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
Customized Additional Specifications  
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  
ICH-Q7 Qualified Utilities  
ICH-Q7 Compliant Manufactured  
Type II Drug Master File  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.


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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