Urea 6M Solution GMP Excipient

GMP Solution

ICH-Q7 GMP Manufactured Product

Urea (6M) Solution

GMP, Excipient Grade
Product Code: UREA-3120

Made With USP/EP Grade Urea And Water For Injection

Minimum Order Quantity: 4,000-liters Lead Time (if no stock): 3-months

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Product Code: UREA-3120

Intended For Use As An Excipient Grade Solution

Urea is used 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. This multi-compendial certified Urea crystal is combined with WFI grade water to manufacture the finished 6M Urea Solution.

CAS #: 57-13-6
Formula: CH₄N₂O
360 grams per Liter Urea
pH of a 6M soln., 25°C = 7-10

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance

Colorless Liquid

Identification (IR)

Conforms to Standard

Molarity

5.8 – 6.2 M

pH @ 25°C

7 - 10

Trace Metals

Arsenic (As)

Copper (Cu)

Iron (Fe)

Lead (Pb)

≤ 5 ppm

MANUFACTURING STATEMENT: Manufactured using Urea raw material purified (in process) to Meet USP/EP compendial specifications.

Printable Version

General Product Description:

The manufacturing of Bio Excipient Grade Urea 6M soln.,
UREA-3120 is performed at BioSpectra’s Bangor, PA facility and is conducted in a multi-purpose processing area using multi-purpose equipment.

Urea 6M solution is a colorless liquid.
Molecular Formula: CH₄N₂O
Molecular Weight: 60.06 g/mol.
6M solution: 360 g/liter
pH: 7-10
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 6M solution, UREA-3120 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
Urea 6M solution manufactured at BioSpectra and any raw materials used in the manufacture of Urea at BioSpectra are not subject to genetic modification.
Manufactured with WFI water.
Synonyms: Carbamide Solution, Carbonyl Diamide Solution

GMP Compliance:

Bio Excipient Grade Urea 6M solution, UREA-3120 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Urea 6M solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for Urea 6M solution is two years from the date of manufacture.

Storage and Shipping Conditions:

Store in a tightly closed container. Store in dry, well-ventilated area with temperature between 15-30° C. Store away from incompatible substances.

Package Sizes:

200 Liter drums, 1,000 - 1,200 L 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.