Urea - Active

BIO ACTIVE GRADE / UR2220

INTENDED FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT

Urea is used as an active substance in topical and transdermal applications.

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

BIO ACTIVE GRADE / UR2220

CAS #: 57-13-6

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 (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.

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

5 ppm maximum

Printable Version

Key Compliance Attributes of
BioSpectra Grades

Bio Active
Grade ICH Q7
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

Yes

Microbial / Endotoxin Tested

Yes

Manufactured in FDA Registered Facility

Yes

Customized Manufacturing Schedule

Yes

Custom Regulatory Packet

Yes

Accelerated Stability

Yes

Type IV Drug Master File

N/A

Video Conference access to BioSpectra Sites

Yes

Complete access to Product Traceability

Yes

Access to Supply Chain Information

Yes

ICH Q7 Qualified Utilities

Yes

ICH Q7 Compliant Manufactured

Yes

Suitable for use as Active Ingredient

Yes

Type II Drug Master File

Available

Find your C of As

General Product Description:

The Manufacturing of Bio Active Grade Urea is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Active Grade Urea is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
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 UR2220 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 and Carbonyldiamide.

GMP Compliance:

Bio Active Grade Urea UR2220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in drug product manufacturing. This Grade of Urea is not suitable to be used as a sterile or injectable Active Pharmaceutical Ingredient, 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° C and 30°C.
Store in a clean and dry area.
Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.