Product Category

Excipient

ICH-Q7 GMP Manufactured Product

URIDINE, LBLE, GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: URID-3250

Intended Use Statement


Uridine is a glycosylated pyrimidine-analog containing uracil attached to a ribose ring via a β-N1-glycosidic bond. It is one of the five standard nucleosides which make up nucleic acid. Uridine is used as a nutrient, an intermediate in pharmaceutical preparations with other GMP pharmaceutical applications.

Product Specifications

ANALYSIS SPECIFICATIONS
Appearance and Color  
White to almost white powder
Bioburden

TAMC

TYMC

≤ 100 CFU/g

≤ 100 CFU/g

Endotoxin  
≤ 0.5 EU/mg
Heavy Metals  
≤ 10 ppm
HPLC Purity  
95.0 – 105.0%
Identification (IR)  
Conforms to Spectrum of Reference Standard
Loss on Drying  
≤ 0.5%
Residue on Ignition  
≤ 0.1%
Transparency  
≥ 98.0%
UV Assay  
≥ 98.0%
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
IPEC cGMP Compliant Manufactured  
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 IV 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.
List of C of As files
No files available right now.

Product Inquiry

Please enter your first name

Please enter title

Please enter product of interest

Enter name of company

Please enter your last name

Please enter your valid email address

Enter position in company

Location of company
Please enter street address

Enter your company state

Invalid Input

Please enter city

Enter zip code

Enter Country

Enter country code

Enter phone number

Enter web address

Please select any option

If resale please fill out the following information
Enter end use customer's full name

Enter end use customer's address

Please select any option

Please select any one option

Please select any option

Invalid Input

Please select any one option

Invalid Input

Invalid Input

Please enter Estimated Release quantity in Liters or Kg

Please enter Regulatory Requirements

Please enter timeframe needed

Please enter Estimated annual demand in liters or kg

Please enter Logistics: Freight

Please enter specificatoin

Validate Recaptcha

COAs and Tech Docs

Product-image
formula-image

URID-3250

CAS #: 58-96-8

Formula: C9H12N2O6

Density: 933 kg/m 3

Sol. In H2O (g/L): 50

F.W.: 244.20 g/mol.

General Product Description:

  • The manufacturing of Bio Pharma Grade Uridine URID-3250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of URID-3250 is cleaned in accordance with BioSpectra's Process Cleaning Validation Master Plan.
  • Uridine is a White to almost white powder.
  • Molecular Formula: C9H12N2O6
  • Molecular Weight: 244.20 g/mol.
  • CAS Number: 58-96-8
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Uridine, URID-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Uridine manufactured at BioSpectra and any raw materials used in the manufacture of Uridine at BioSpectra are not subject to genetic modification.
  • Synonyms: 1-β-D-Ribofuranosyluracil, Uracil-1-β-D- ribofuranoside


GMP Compliance:

Bio Excipient Grade Uridine, URID-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Uridine is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for Uridine is two years from the date of manufacture.

Storage and Shipping Conditions:

Keep container tightly closed and store between 2-8°, do not store above 20°C. Store in a dry and well-ventilated area.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging