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Product Category

GMP Solution

ICH-Q7 GMP Manufactured Product

Urea 6M, GMP Excipient Grade

Made With USP/EP Grade Urea And Water For Injection

Product Code: UREA-3120

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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.

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

≤ 5 ppm

≤ 5 ppm

≤ 5 ppm 

 

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

Printable Version

List of C of As files
UREA-0122-00003_UREA-3120.pdf
UREA-0121-00042_UREA-3120.pdf
UREA-0121-00041_UREA-3120.pdf

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COAs and Tech Docs

Product-image
formula-image

UREA-2220 | UR2220

CAS #: 57-13-6

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

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:

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

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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging