Excipient
ICH-Q7 GMP Manufactured ProductUREA, LBLE, USP, EP, GMP Excipient Grade
Low Bioburden, Low Endotoxin, Multicompendial, GMP Manufactured
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.
Product Specifications
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ANALYSIS |
SPECIFICATIONS (USP) |
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|---|---|---|---|
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0.04% max. | ||
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White / Crystals | ||
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98.0 - 102.0% | ||
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2.5 EU/g max. | ||
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None Detected None Detected None Detected |
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10 ppm max. | ||
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Passes Test | ||
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Passes Test | ||
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≤ 0.1% ≤ 2.0% ≤ 0.1% |
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| 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. |
|
ANALYSIS |
SPECIFICATIONS (EP) |
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|---|---|---|---|
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98.5 – 101.5% | ||
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Clear and Colorless | ||
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Passes Test | ||
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500 ppm max. | ||
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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 | ||
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
| List of C of As files |
|---|
|
UR3250-004-0620.pdf |
|
UR3250-003-0620.pdf |
|
UR3250-002-0620.pdf |
|
UR3250-001-0120.pdf |
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
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Assay/Organic Impurities
- Nitrosamine Risk Assessment
- Label Copy
- USMCA Statement
UREA-3250 | UR3250
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.)
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.
Additional Packaging Information
https://www.biospectra.us/technical/packaging