Uridine Excipient GMP

Excipient

ICH-Q7 GMP Manufactured Product

URIDINE

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

*Low Bioburden, Low Endotoxin

Minimum Order Quantity: If Stock-10kg/ No Stock-100kg Lead Time: 3-6 months

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UNIT SIZE

QUANTITY

100g

500g

1kg

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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.

CAS #: 58-96-8
Formula: C₉H₁₂N₂O₆Density: 933 kg/m³Sol. In H₂O (g/L): 50
F.W.: 244.20 g/mol.

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color

White to almost white powder

Bioburden

TAMC

TYMC

≤ 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

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.

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.