Product Category
Active Substance (API)
ICH-Q7 GMP Manufactured Active Drug SubstanceUREA, USP, API Grade
Product Code: UREA-2220 | Previously: UR2220
Intended Use Statement
Urea is used as an active substance in topical and transdermal applications.
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. | ||||||||||||
| Melting Range | 132-135 ˚C | ||||||||||||
| Residue on Ignition | 0.010% max. | ||||||||||||
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| Key Compliance Attributes of BioSpectra Grades | Bio Active 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 Active 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
- 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
- Genotoxic Impurities
- Catalyst
- Test Methods
- IRGAFOS
- Assay/Organic Impurities
- Stability Report
CAS #: 57-13-6
Formula:
CH4N2O
Solubility in Water (g/L): 480 @ 20˚C
F.W.: 60.06 g/mol
pH @ 20C: 7.2 (10% soln.)
General Product Description:
- The Manufacturing of Bio Active Grade UREA-2220 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 UREA-2220 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, UREA-2220 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Urea is not suitable to be used as a Sterile or Injectable 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° C and 30°C.
- Store in a clean and dry area.
- Store in the original container.
Package Sizes:
10kg, 25kg and 50kg pails.