Product Category

LBLE Active Substance (API)

ICH-Q7 GMP Manufactured Active Drug Substance

URIDINE, LBLE, API Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: URID-2250

Intended Use For Use As An Active Pharmaceutical Ingredient


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
Ammonium  

≤ 100 ppm

Appearance

 

 White Crystalline Powder

Arsenicum

 

≤ 2 ppm

Assay (HPLC)

 

97 – 102% (on anhydrous)

Bacterial Endotoxins

 

≤ 0.5 EU/mg

Dry Substance  

≥ 99.0%

Heavy Metals

 

≤ 10 ppm

Identification A (IR)

 

Positive

Identification B (HPLC)

 

Positive

Methanol

 

≤ 1000 ppm

Melting Point

167° - 170°C

pH of solution (5%, water)  4.0 – 6.0
Phosphates  ≤ 1000 ppm
Purity (HPLC)

≥ 97% (main peak area %)

Related Substances (HPLC)

Uracil

Pseudouridine

Impurity RRT about 1.6

Each single unknown

Total Impurities

 ≤ 0.5%

≤ 2%

≤ 0.3%

≤ 0.1%

≤ 3.0%

 Transmittance of solution (5%, water)

≥ 95.0%

 Water Content (KF)  ≤ 1.0%
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Active Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image
Suitable for use as Active Ingredient  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Active 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.

 

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COAs and Tech Docs

Product-image
formula-image

URID-2250

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 Active Grade Uridine is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of Bio Active Grade Uridine is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • Uridine is a White Crystalline 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-2250 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 Active Grade Uridine, URID-2250 is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Uridine is not suitable to be used as a Sterile or Injectable 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:

Keep container tightly closed and store between 2-8°C, do not store above 20°C. Store in a dry and well-ventilated area.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging