Urea - Active

BIO ACTIVE GRADE | UR2220

C of As and Tech Docs

INTENDED FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT

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BIO ACTIVE GRADE / UR2220

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 as an active substance in topical and transdermal applications.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

ANALYSIS SPECIFICATIONS
Alcohol Insoluble Matter 0.04% max.
Appearance and Color White / Crystals
Assay 98.0-102.0%
  DNase
Enzymes Protease
  RNase
None Detected
None Detected
None Detected
Heavy Metals 10 ppm max.
Identification A (IR) Passes Test
Identification B Passes Test
  Urea RCA
Impurities Total
  Unspecified
<0.1%
<2.0%
<0.1%
Insoluble Matter

0.010% max.
Loss on Drying 1.0% max.
Melting Range 132-135 ˚C
Residue on Ignition 0.010% max.
  Arsenic (As)
Trace Metals Copper (Cu)
  Iron (Fe)
  Lead (Pb)
5 ppm maximum
5 ppm maximum
5 ppm maximum
5 ppm maximum
Printable Version
Key Compliance Attributes of
BioSpectra Grades		 Bio Active
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  
Yes
Customized Manufacturing Schedule  
Yes
Custom Regulatory Packet  
Yes
Accelerated Stability  
Yes
Type IV Drug Master File N/A
Video Conference access to BioSpectra Sites Yes
Complete access to Product Traceability Yes
Access to Supply Chain Information Yes
ICH Q7 Qualified Utilities Yes
ICH Q7 Compliant Manufactured Yes
Suitable for use as Active Ingredient Yes
Type II Drug Master File Available
List of C of As files
UR2220-006-0320.pdf
UR2220-005-1218.pdf
UR2220-004-1118.pdf
UR2220-003-0918.pdf
UR2220-002-0918.pdf
UR2220-001-0918.pdf

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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 Active Grade Urea 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 UR2220 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 UR2220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in drug product manufacturing. This Grade of Urea is not suitable to be used as a sterile or injectable Active Pharmaceutical Ingredient, 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° C and 30°C.
  • Store in a clean and dry area.
  • Store in the original container.

Package Sizes:

10kg, 25kg and 50kg pails.