Urea 6M Solution, GMP, Excipient

GMP Solution

ICH Q7 GMP Manufactured Product

Urea 6M Solution

GMP, Excipient
Product Code: UREA-3120

Made with USP/EP Grade Urea and Water for Injection

Minimum Order Quantity: 8,000-liters
Lead Time (if no stock): 3-months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

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Product Code: UREA-3120

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

Urea is used 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. BioSpectra manufactures GMP, multicompendial Urea crystal which is combined with water for injection to manufacture the finished 6M Urea Solution.

CAS #: 57-13-6
Formula: CH₄N₂O
M.W.: 60.06 g/mol

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

Colorless Solution

Identification, IR

Conforms to Reference Standard

Molarity

5.8 – 6.2 M

pH, 25°C

7 - 10

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

< = 5 ppm

Printable Version

Key Product Features:

The manufacturing of Urea 6M Solution is performed at BioSpectra's Bangor, PA facility.
Appears as a colorless solution
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 Solution; Carbonyl Diamide Solution

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:

200L drum and 1,000L - 1,200L totes.

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.