Excipient
ICH-Q7 GMP Manufactured ProductURIDINE, 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 | ||
|---|---|---|---|
|
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% |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
|---|---|---|---|
|
 |
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- Prop 65
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Degradation and Impurity
- Stability Report
- Nitrosamine Risk Assessment
- Validation Report
- Elemental Impurity Assessment
- Label Copy
- Process Flow Diagram- Suite N02
URID-3250
CAS #: 58-96-8
Formula: C9H12N2O6
Density: 933 kg/m 3
Sol. In H2O (g/L): 50
F.W.: 244.20 g/mol.
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