Urea USP / EP
BIO EXCIPIENT GRADE | UR3250
INTENDED OR USE AS AN EXCIPIENT


BIO EXCIPIENT GRADE | UR3250
CAS #: 57-13-6
Molecular Formula:
CH4N2O
Solubility in Water (g/L): 480 @ 20˚C
F.W.: 60.06 g/mol
pH @ 20°C: 7.2 (10% soln.)
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- NAFTA Statement
- Stability Data Statement
- Slip Agent Statement
- Nitrosamine Statement
- Catalyst
- Test Methods
- IRGAFOS
- Assay/Organic Impurities
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.
These are general specifications. BioSpectra will customize our products to meet your quality based requirements.
USP Compendia
ANALYSIS |
SPECIFICATIONS |
||
---|---|---|---|
|
0.04% max. | ||
|
White / Crystals | ||
|
98.0 - 102.0% | ||
|
2.5 EU/g max. | ||
|
None Detected None Detected None Detected |
||
|
10 ppm max. | ||
|
Passes Test | ||
|
Passes Test | ||
|
≤ 0.1% ≤ 2.0% ≤ 0.1% |
||
Insoluble Matter | 0.010% max. | ||
|
1.0% max. | ||
|
132 - 135 ̊ C | ||
|
0.010% max. | ||
|
5 ppm max. 5 ppm max. 5 ppm max. 5 ppm max. |
EP Compendia
ANALYSIS |
SPECIFICATIONS |
||
---|---|---|---|
|
98.5 – 101.5% | ||
|
Clear and Colorless | ||
|
Passes Test | ||
|
500 ppm max. | ||
|
0.1% max. | ||
|
10 ppm max. | ||
|
132 - 135oC | ||
|
Passes Test | ||
|
Passes Test | ||
|
Passes Test | ||
|
1.0% max. | ||
|
0.1% max. |
Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH Q7 Compliant Manufactured | ||
---|---|---|---|
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Yes | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Available | ||
|
Yes | ||
|
Yes | ||
|
Yes |
List of C of As files |
---|
UR3250-004-0620.pdf |
UR3250-003-0620.pdf |
UR3250-002-0620.pdf |
UR3250-001-0120.pdf |
General Product Description:
- The manufacturing of Bio Excipient Grade Urea UR3250
- 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 UR3250 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.
Bio Excipient Grade Urea, UR3250 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products including use in further manufacturing of parenteral grade products. This grade of Urea is not sterile and requires terminal sterilization. It is not intended for use as an API, final 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 and 25kg pails and 50kg drums.