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Excipient

ICH-Q7 GMP Manufactured Product

UREA

USP, GMP, Excipient Grade
Product Code: UREA-3220

Minimum Order Quantity: 500kg Lead Time (if no stock): 3 months
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QUANTITY
Product Code: UREA-3220 | Previously: UR3220
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 repurified, GMP Urea in its FDA registered, US facility.

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.)

Product Specifications

ANALYSIS SPECIFICATIONS
Alcohol Insoluble Matter 0.04% max.
Appearance and Color White / Crystals
Assay 98.0 - 102.0%
Enzymes  

DNase

Protease

RNase

None Detected

None Detected

None Detected

Heavy Metals 10 ppm max.
Identification A (IR) Passes Test
Identification B Passes Test
 

Urea RCA

Impurities

Total

 

Unspecified

≤ 0.1%

≤ 2.0%

≤ 0.1%

Insoluble Matter

0.010% max.

Loss on Drying

1.0% max.

Melting Range 132-135˚C
Residue on Ignition 0.010% max.
 Trace Metals  

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

5 ppm maximum

5 ppm maximum

5 ppm maximum

5 ppm maximum

 

Printable Version

General Product Description:

  • The manufacturing of Urea UREA-3220 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 product.
  • Molecular Formula: CH4N2O
  • Molecular Weight: 60.06 g/mol.
  • 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 UREA-3220 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: Carbamide, Carbonyldiamide.

GMP Compliance:

Bio Excipient Grade Urea, UREA-3220 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, 25kg and 50kg pails.

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.