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 For Critical Biopharma Applications


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 - Assay 98.0-102.0%
HPLC - Purity  
≥ 99.0%
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

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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:

Store at ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

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