Urea - GMP Denaturant

BIO PHARMA GRADE | UR4220 | CAS# 57-13-6

INTENDED OR 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. Some proteins will be irreversibly altered after interaction with Urea solutions and may lose their binding function. Applications include solubilizing proteins from inclusion bodies, increasing solubility of hydrophobic peptides and proteins and denaturing proteins. Urea may be used with guanidine hydrochloride in the refolding of denatured proteins into their native or active form. Urea also denatures nucleic acid structures for use in electrophoresis.

These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

BIO PHARMA GRADE / UR4220

CAS #: 51-13-6

Molecular Formula:

CH₄N₂O

Solubility in Water (g/L): 545

F.W.: 60.06 g/mol

pH @ 20°C: 7.5 - 9.5

SDS
Spec Sheet
Compliance
C of As

ANALYSIS

SPECIFICATIONS

Alcohol Insoluble Matter

0.04% max.

Appearance and Color

White / Crystals

Assay

98.0 - 102.0%

	DNase
Enzymes	Protease
	RNase

None Detected

Heavy Metals

10 ppm max.

Identification A

Passes Test

Identification B

Passes Test

Identification (IR)

Passes Test

Insoluble Matter

0.010% max.

Loss on Drying

1.0% max.

Melting Range

132 - 135 ˚C

Residue on Ignition

0.010% max.

Sulfate

0.001% maximum

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

5 ppm maximum

Printable Version

Key Compliance Attributes of
BioSpectra Grades

Bio Pharma
Grade IPEC
GMP
Compliant
Manufactured

Suitable for Research and Diagnostic

Yes

Each Batch 100% Analyzed

Yes

Management of Change

Yes

Validated Analytical Methods

Yes

Compendial Testing

Yes

Trace Metals Analyzed

Yes

Two Year Stability

Yes

BioSpectra Supply Chain Audit Trail

Yes

Product Origin Statement

Yes

Customer Quality Audits

Yes

Customized Additional Specifications

Yes

Multi-Compendial Testing

Yes

Enzyme Tested

Yes

Validated Manufacturing Process

Yes

US Manufactured at BioSpectra

Yes

IPEC cGMP Compliant Manufactured

Yes

Suitable for use as Excipient

Available

Microbial / Endotoxin Tested

Available

Manufactured in FDA Registered Facility

Available

Customized Manufacturing Schedule

Available

Custom Regulatory Packet

Available

Accelerated Stability

Available

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General Product Description:

The manufacturing of Bio Pharma Grade Urea UR4220 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 UR4220 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: Carbaminde, Carbonyldiamide.

GMP Compliance:

Bio Pharma Grade Urea UR4220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. This Grade of Urea is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or household item.

Expiration/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.