Product Category

Excipient

ICH-Q7 GMP Manufactured Product

UREA, USP, EP, JP, GMP Excipient Grade

Product Code: UREA-3221 | Previously: UR3221

Intended Use Statement


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

ANALYSIS

SPECIFICATIONS (USP)

Appearance and Color  
White Crystalline Powder
Assay  
98.0-102.0%
Chloride 0.007% max.
Elemental Impurities Complies with USP <232><233>
Identification A (IR)  
Passes Test
Identification B (HPLC)  
Retention Time Corresponds to Standard
Identification C  
Red Purple Color Develops
Identification D  
White Precipitate is Formed
In ethanol (96%) Insoluble Parts  
0.04% maximum
Organic Impurities

Urea RCA

Individual

Total

NMT 0.1%

NMT 0.1%

NMT 2.0%

Residual Solvents  
Complies with USP <467>
Sulfated Ash (Residue on Ignition)  
0.10% max.
Sulfate  
0.010% max.

ANALYSIS

SPECIFICATIONS (EP)

Assay  
98.5 – 101.5%
Appearance of Solution (5% solution; water)  
Clear and Colorless
Alkalinity  
Passes Test
Ammonium  
500 ppm max.
Biuret  
0.1% max.
Heavy Metals  
10 ppm max.
Identification A  
132 - 135 oC
Identification B (IR)  
Passes Test
Identification C  
Passes Test
Identification D  
Passes Test
Loss on Drying  
1.0% max.
Sulfated Ash  
0.10% max.

 

ANALYSIS

SPECIFICATIONS (JP)

Assay  
99.0% minimum
Chloride  
0.007% max.
Ethanol-insoluble substances  
0.04% max.
Heavy Metals  
20 ppm max.
Identification 1  
Red Purple Color Develops
Identification 2  
White Precipitate is Formed
Melting Point  
132.5-134.5°C
Sulfated Ash (Residue on Ignition)  
0.1% max.
Sulfate  
0.010% max.

 

ANALYSIS

SPECIFICATIONS

Assay  
99.0 – 100.5%
Assay (Dried Basis)  
99.0 – 101.0%

Printable Version

Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates 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.

 

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General Product Description:

  • The manufacturing of Bio Excipient Grade Urea UREA-3221 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-3221 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 STATEMENT: Based on the manufacturing process and the controlled handling, storage and analysis of this product, this product complies with the requirements and specifications listed in the current USP method <467> Tables 1, 2, 3, or 4.



GMP Compliance:

Bio Excipient Grade Urea, UREA-3221 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