Urea USP / EP / JP

BIO EXCIPIENT GRADE | UR3221

C of As and Tech Docs

INTENDED FOR USE AS AN EXCIPIENT

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BIO EXCIPIENT GRADE / UR3221

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.)

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 Requirements

ANALYSIS

SPECIFICATIONS

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.

 

EP Requirements

 

ANALYSIS

SPECIFICATIONS

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.

JP Requirements

ANALYSIS

SPECIFICATIONS

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
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The manufacturing of Bio Excipient Grade Urea UR3221
  • 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 UR3221 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 requirements and specifications listed in the current USP method <467>Tables 1, 2, 3, or 4.



GMP Compliance:

Bio Excipient Grade Urea, UR3221 is manufactured in accordance with ICH Q7 compliant cGMP guidelines and is suitable for use “downstream” in the manufacture of drug products but not for 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, find 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