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Excipient

ICH Q7 GMP Manufactured Product

URIDINE

LBLE*, GMP, Excipient
Product Code: URID-3250

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 10kg
Lead Time: 6-months

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Product Code: URID-3250
Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

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

CAS #: 58-96-8
Formula: C9H12N2O6
F.W.: 244.20 g/mol.

Product Specifications

ANALYSIS SPECIFICATIONS
Appearance and Color  
White to Almost White Powder
Assay, HPLC 98.0 - 102.0%
Assay, UV > = 98.0%
Endotoxin < = 0.5 EU/mg
Heavy Metals (Pb) < = 10 ppm
Identification, IR Conforms to Reference Standard
Loss on Drying < = 0.5%
Purity, HPLC > = 99%
Microbial Content

TAMC

TYMC

< = 100 CFU/g

< = 100 CFU/g

Residue on Ignition < = 0.1%
Transparency > = 98.0%
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Key Product Features:

  • The manufacturing of Uridine, URID-3250 is performed at BioSpectra's Bangor, PA facility.
  • Appears as a white to almost white powder
  • Manufactured in accordance with ICH Q7
  • Manufactured in a hormone free and animal free environment
  • Contains no known major food allergens (as defined by FDA and WHO)
  • The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
  • Is not subject to genetic modification
  • Synonyms: 1-β-D-Ribofuranosyluracil; Uracil-1-β-D- ribofuranoside

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS. 

Package Sizes:

10kg, 25kg, and 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.