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Product Category

Excipient

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

ANALYSIS

SPECIFICATIONS (USP)
Appearance and Color  
White Crystalline Powder
Assay  
98.0-102.0%
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

Individual

Total

NMT 0.1%

NMT 0.1%

NMT 2.0%
Residual Solvents  
Complies with USP <467>
Sulfated Ash (Residue on Ignition)  
0.10% max.
Sulfate  
0.010% max.

ANALYSIS

SPECIFICATIONS (EP)
Assay  
98.5 – 101.5%
Appearance of Solution (5% solution; water)  
Clear and Colorless
Alkalinity  
Passes Test
Ammonium  
500 ppm max.
Biuret  
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.

 

ANALYSIS

SPECIFICATIONS (JP)
Assay  
99.0% minimum
Chloride  
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  
132.5-134.5°C
Sulfated Ash (Residue on Ignition)  
0.1% max.
Sulfate  
0.010% max.

 

ANALYSIS

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

Printable Version

List of C of As files
UREA-0122-00030_UREA-3221.pdf
UREA-0122-00019_UREA-3221.pdf
UREA-0122-00014_UREA-3221.pdf
UREA-0122-00010_UREA-3221.pdf

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COAs and Tech Docs

Product-image
formula-image

UREA-3221 | UR3221

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.)

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

https://www.biospectra.us/technical/packaging