ICH-Q7 GMP Manufactured Product
*Low Bioburden, Low Endotoxin
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.
CAS #: 58-96-8
Formula: C9H12N2O6
Density: 933 kg/m 3
Sol. In H2O (g/L): 50
F.W.: 244.20 g/mol.
| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
White to almost white powder | ||
|
≤ 100 CFU/g ≤ 100 CFU/g |
||
|
≤ 0.5 EU/mg | ||
|
≤ 10 ppm | ||
| HPLC - Assay | 98.0-102.0% | ||
|
≥ 99.0% | ||
|
Conforms to Spectrum of Reference Standard | ||
|
≤ 0.5% | ||
|
≤ 0.1% | ||
|
≥ 98.0% | ||
|
≥ 98.0% |
Printable Version
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.
The recommended retest period for Uridine is two years from the date of manufacture.
Store at ambient temperature.
10kg, 25kg and 50kg pails.
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.