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% | ||||||||||||
|
|
||||||||||||
| Heavy Metals | 10 ppm max. | ||||||||||||
| Identification A (IR) | Passes Test | ||||||||||||
| Identification B | Passes Test | ||||||||||||
|
|
||||||||||||
| Insoluble Matter |
0.010% max. |
||||||||||||
| Loss on Drying | 1.0% max. | ||||||||||||
| Melting Range | 132-135 ˚C | ||||||||||||
| Residue on Ignition | 0.010% max. | ||||||||||||
|
|
| Key Compliance Attributes of BioSpectra Grades |
Bio Active Grade ICH Q7 Compliant Manufactured |
||
|---|---|---|---|
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
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 |
| PDF's | |
|---|---|
|
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.