Product Category


ICH-Q7 GMP Manufactured Product

UREA, USP, EP, JP, GMP Excipient Grade

Product Code: UREA-3221 | Previously: UR3221

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.

Product Specifications



Appearance and Color  
White Crystalline Powder
Chloride 0.007% max.
Elemental Impurities Complies with USP <232><233>
Identification A (IR)  
Passes Test
Identification B (HPLC)  
Retention Time Corresponds to Standard
Identification C  
Red Purple Color Develops
Identification D  
White Precipitate is Formed
In ethanol (96%) Insoluble Parts  
0.04% maximum
Organic Impurities

Urea RCA



NMT 0.1%

NMT 0.1%

NMT 2.0%

Residual Solvents  
Complies with USP <467>
Sulfated Ash (Residue on Ignition)  
0.10% max.
0.010% max.



98.5 – 101.5%
Appearance of Solution (5% solution; water)  
Clear and Colorless
Passes Test
500 ppm max.
0.1% max.
Heavy Metals  
10 ppm max.
Identification A  
132 - 135 oC
Identification B (IR)  
Passes Test
Identification C  
Passes Test
Identification D  
Passes Test
Loss on Drying  
1.0% max.
Sulfated Ash  
0.10% max.




99.0% minimum
0.007% max.
Ethanol-insoluble substances  
0.04% max.
Heavy Metals  
20 ppm max.
Identification 1  
Red Purple Color Develops
Identification 2  
White Precipitate is Formed
Melting Point  
Sulfated Ash (Residue on Ignition)  
0.1% max.
0.010% max.




99.0 – 100.5%
Assay (Dried Basis)  
99.0 – 101.0%

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General Product Description:

  • The manufacturing of Bio Excipient Grade Urea UREA-3221 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-3221 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 STATEMENT: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.

GMP Compliance:

Bio Excipient Grade Urea, UREA-3221 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

Additional Packaging Information