ICH-Q7 GMP Manufactured Product
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.)
| ANALYSIS | SPECIFICATIONS | |||||||||
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| Alcohol Insoluble Matter | 0.04% max. | |||||||||
| Appearance and Color | White / Crystals | |||||||||
| Assay | 98.0 - 102.0% | |||||||||
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| Heavy Metals | 10 ppm max. | |||||||||
| Identification A (IR) | Passes Test | |||||||||
| Identification B | Passes Test | |||||||||
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| Insoluble Matter |
0.010% max. |
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| Loss on Drying |
1.0% max. |
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| Melting Range | 132-135˚C | |||||||||
| Residue on Ignition | 0.010% max. | |||||||||
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Printable Version
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.
The recommended retest period for Urea is two years from the date of manufacture.
10kg, 25kg and 50kg pails.
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.