Excipient
ICH-Q7 GMP Manufactured ProductUREA, USP, GMP Excipient Grade
Product Code: UREA-3220 | Previously: UR3220
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 repurified, GMP Urea in its FDA registered, US facility.
Product Specifications
| ANALYSIS | SPECIFICATIONS | |||||||||
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| Alcohol Insoluble Matter | 0.04% max. | |||||||||
| Appearance and Color | White / Crystals | |||||||||
| Assay | 98.0 - 102.0% | |||||||||
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| Heavy Metals | 10 ppm max. | |||||||||
| Identification A (IR) | Passes Test | |||||||||
| Identification B | Passes Test | |||||||||
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| Insoluble Matter |
0.010% max. |
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| Loss on Drying |
1.0% max. |
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| Melting Range | 132-135˚C | |||||||||
| Residue on Ignition | 0.010% max. | |||||||||
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| 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. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Assay/Organic Impurities
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
- USMCA Statement
- UPLC Report
UREA-3220 | UR3220
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 Urea UREA-3220 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 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 UREA-3220 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, Carbonyldiamide.
GMP Compliance:
Bio Excipient Grade Urea, UREA-3220 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, 25kg and 50kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging