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

Product Inquiry COAs Spec Sheet

Click the button above for pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Please Use the Product Inquiry button (above) for bulk volumes.

Customer Service

First Name *

Last Name *

Company Name *

Position in Company

Email *

Company website

Company phone with country code *

Country where product is to be used *

Street Address *

City *

State *

Zip Code *

Country *

Additional Information Needed/Requested

Please Use the Product Inquiry button (above) for bulk volumes.

UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

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.