Urea Excipient LBLE GMP USP EP

Excipient

ICH-Q7 GMP Manufactured Product

UREA

USP, EP, LBLE*, GMP, Excipient Grade
Product Code: UREA-3250

*Low Bioburden, Low Endotoxin

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

Product Inquiry COAs Spec Sheet

Click the button above for additional pricing, lead times, MOQs and other inquiries.

Product Inquiry

Product(s) of Interest *

First Name *

Last Name *

Title & Position in Company *

Email *

Your Direct Phone Number & Country Code *

Name of Your Company *

Website of Your Company *

Address of Company *

Country where product is to be used *

Name of Your Customer – the End User *

Website of Your Customer – the End User *

Intended Application/Use if known

Package Size Requested *

Estimated Release Quantity per PO in Liters or Kgs *

Estimated Annual Demand in Liters or Kgs *

Regulatory or Compendial Requirements *

INCO Terms requested *

Please Use the Product Inquiry button (above) for bulk volumes.

Customer Service

First Name *

Last Name *

Company Name *

Position in Company

Email *

Company website

Company phone with country code *

Country where product is to be used *

Street Address *

City *

State *

Zip Code *

Country *

Additional Information Needed/Requested

Please Use the Product Inquiry button (above) for bulk volumes.

UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: UREA-3250 | Previously: UR3250

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 re-purified, 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 (USP)

Alcohol Insoluble Matter

0.04% max.

Appearance and Color

White / Crystals

Assay

98.0 - 102.0%

Endotoxin

2.5 EU/g max.

Enzymes

DNase

Protease

RNase

None Detected

Heavy Metals

10 ppm max.

Identification A (IR)

Passes Test

Identification B

Passes Test

Impurities

Organic

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 max.

ANALYSIS

SPECIFICATIONS (EP)

Assay

98.5 – 101.5%

Appearance of Solution

Clear and Colorless

Alkalinity

Passes Test

Ammonium

500 ppm max.

Biuret

0.1% max.

Heavy Metals

10 ppm max.

Identification A

132 - 135^oC

Identification B (IR)

Passes Test

Identification C

Passes Test

Identification D

Passes Test

Loss on Drying

1.0% max.

Residue on Ignition

0.1% max.

Printable Version

General Product Description:

The manufacturing of Bio Excipient Grade UREA-3250 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 powder.
Molecular Formula: CH₄N₂O
Molecular Weight: 60.06 g/mol.
CAS #: 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-3250 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: Urea, Carbamide, Carbonyldiamide

Product Statements:

RESIDUAL SOLVENTS: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirement and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.

GMP Compliance:

Bio Excipient Grade Urea, UREA-3250 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 and 25kg pails and 50kg drums.

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.