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GMP Biotech Product

UREA BIOTECH

USP, GMP
Product Code: UREA-4221

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Product Code: UREA-4221
Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

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: NH2CONH2
F.W.: 60.06 g/mol
CAS #: 57-13-6

Product Specifications

ANALYSIS

SPECIFICATIONS

Alcohol Insoluble Matter (USP)

 

< = 0.04%

Ammonium  
< = 500 ppm
Appearance and Color  
White Crystals
Assay (USP)  
98.0 - 102.0%
Chloride < = 500 ppm
Enzymes

DNase

Protease

RNase

None Detected

None Detected

None Detected

Identification A, IR (USP)  
Conforms to Reference Standard
Identification B (USP)  
Conforms to Reference Standard
Melting Range

132 – 135˚ C

pH (5M), 20°C

7.5 - 9.5

Organic Impurities (USP)

Urea Related Compound A

Any Individual Unspecified Impurities

Total Impurities 

< = 0.1%

< = 0.1 %

< = 2.0%

Residue on Ignition (USP)  
< = 0.010%
Sulfate  
< = 500 ppm
Trace Metals

Aluminum (Al)

Arsenic (As)

Calcium (Ca)

Copper (Cu)

Iron (Fe)

Lead (Pb)

Magnesium (Mg)

Potassium (K)

Phosphorous (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

Printable Version

Key Product Features:

  • Appears as a white crystalline product
  • Manufactured in accordance with IPEC
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Contains no known major food allergens (as defined by FDA and WHO)
  • The final product and 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:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

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.