Urea USP, EP, GMP, Excipient

Excipient

ICH Q7 GMP Manufactured Product

UREA

USP, EP, LE*, GMP, Excipient
Product Code: UREA-3250

*Low Endotoxin

Minimum Order Quantity: 500kg
Lead Time (if no stock): Up to 6-months

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Product Code: UREA-3250

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Urea is used in biochemistry and molecular biology as a protein denaturant with low UV absorptivity. In addition to increasing the solubility of hydrophobic molecules, Urea denatures proteins by unfolding them and altering their three-dimensional structure.

CAS #: 57-13-6
Formula: NH₂CONH₂
F.W.: 60.06 g/mol
Water Solubility (20°C): 264 g/L
pH (10% Solution): 7.5 - 9.5

Product Specifications

ANALYSIS

SPECIFICATIONS

Alcohol Insoluble Matter (USP)

< = 0.04%

Alkalinity (EP)

Passes Test

Appearance and Color

White Crystals

Appearance of Solution (EP)

Clear and Colorless

Assay (USP)

98.0 - 102.0%

Assay, Dried Basis (EP)

98.5 - 101.5%

Ammonium (EP)

< = 500 ppm

Biuret (EP)

< = 0.1%

Endotoxin

< = 2.5 EU/g

Enzymes

DNase

Protease

RNase

None Detected

Identification, IR (USP-A/EP-B)

Conforms to Reference Standard

Identification B (USP)

Conforms to Reference Standard

Identification A (EP)

132 - 135°C

Identification C (EP)

Passes Test

Identification D (EP)

Passes Test

Insoluble Matter

< = 0.010%

Organic Impurities (USP)

Urea Related Compound A

Any Individual Unspecified Impurity

Total Impurities

< = 0.1%

< = 2.0%

Loss on Drying (EP)

< = 1.0%

Residue on Ignition / Sulfated Ash (USP/EP)

< = 0.010%

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 5 ppm

Printable Version

Key Product Features:

The manufacturing of Urea, UREA-3250 is performed at BioSpectra's Stroudsburg, PA facility.
Appears as white crystals
Manufactured in accordance with ICH Q7
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 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:

10kg, 25kg, and 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.