Urea GMP Excipient

Excipient

ICH-Q7 GMP Manufactured Product

UREA

USP, GMP, Excipient Grade
Product Code: UREA-3220

Minimum Order Quantity: 500kg Lead Time (if no stock): 3 months

Product Inquiry COAs Spec Sheet

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

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1x10kg

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Product Code: UREA-3220 | Previously: UR3220

Intended For Use As An Excipient

Urea is used in biochemistry and molecular biology 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 in its FDA registered, US facility.

CAS #: 57-13-6
Formula: CH₄N₂O
Sol. In H₂O (g/L): 480 @ 20˚C
F.W.: 60.06 g/mol
pH @ 20°C: 7.2 (10% soln.)

Product Specifications

ANALYSIS

SPECIFICATIONS

Alcohol Insoluble Matter

0.04% max.

Appearance and Color

White / Crystals

Assay

98.0 - 102.0%

Enzymes	DNase
	Protease
	RNase

None Detected

Heavy Metals

10 ppm max.

Identification A (IR)

Passes Test

Identification B

Passes Test

	Urea RCA
Impurities	Total
	Unspecified

≤ 0.1%

≤ 2.0%

≤ 0.1%

Insoluble Matter

0.010% max.

Loss on Drying

1.0% max.

Melting Range

132-135˚C

Residue on Ignition

0.010% max.

Trace Metals	Arsenic (As)
	Copper (Cu)
	Iron (Fe)
	Lead (Pb)

5 ppm maximum

Printable Version

General Product Description:

The manufacturing of Urea UREA-3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
Urea is a White Crystalline product.
Molecular Formula: CH4N2O
Molecular Weight: 60.06 g/mol.
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 UREA-3220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
Urea manufactured at BioSpectra and any raw materials used in the manufacture of Urea at BioSpectra are not subject to genetic modification.
Synonyms: Carbamide, Carbonyldiamide.

GMP Compliance:

Bio Excipient Grade Urea, UREA-3220 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Urea is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

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

Storage and Shipping Conditions:

Ship and Store between 15˚ and 30˚C.
Store in clean and dry area.
Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.

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.