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GMP Biotech Product

UREA BIOTECH

USP, GMP

COAs Spec Sheet

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Product Code: UREA-4221
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

Urea Biotech is a high purity, GMP Reagent Grade. 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.

Formula: CH4N2O
F.W.: 60.06 g/mol
CAS #: 57-13-6

Product Specifications

ANALYSIS

SPECIFICATIONS (USP)

Enzymes

DNase

Protease

RNase

None Detected

None Detected

None Detected

Trace Metals

Aluminum (Al)

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Potassium (K)

Phosphorus (P)

Sodium (Na)

Zinc (Zn)

≤ 5 ppm

≤ 5 ppm

≤ 10 ppm

≤ 5 ppm

≤ 5 ppm

≤ 5 ppm

≤ 5 ppm

≤ 50 ppm

≤ 50 ppm

≤ 50 ppm

≤ 5 ppm

Assay (USP)  
98.0 – 102.0%
Appearance and Color  
White / Crystals
Heavy Metals  
10 ppm max.
Identification A (IR) (USP)  
Passes Test
Identification B (USP)  
Passes Test
Alcohol-Insoluble Matter (USP)  
0.010% max.
Impurities (USP)

Urea Related Compound A

Any Individual Unspecified Impurities

Total Impurities 

≤ 0.1%

≤ 0.1 %

≤ 2.0%

Loss on Drying (USP) 1.0% max.
Melting Range  
132 – 135˚ C
Residue on Ignition (USP)  
0.010% max.
Ammonia (NH4)  
≤ 0.05%
pH  
7.5 – 9.5
Chloride Content  
≤ 0.05%
Sulfate  
≤ 0.05%
Printable Version

General Product Description:

Molecular Formula: CH4N2O
Molecular Weight: 60.06 g/mol.
CAS Number: 57-13-6

Urea Biotech:

  • Urea is a white crystalline product
  • Is manufactured under an ICH-Q7 Quality Managed cGMP System
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Has no known major food allergens (as defined by FDA and WHO)
  • The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
  • Is not subject to genetic modification
  • Synonyms: Carbamide, Carbonyl diamide.

Shelf Life Policy:

Three-year expiry from the date of manufacture.

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Size:

100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.