Uridine GMP, Excipient

Excipient

ICH Q7 GMP Manufactured Product

URIDINE

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

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: 10kg
Lead Time: 3-6 months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

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: C₉H₁₂N₂O₆F.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

Residue on Ignition

< = 0.1%

Transparency

> = 98.0%

Printable Version

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.