API
ICH-Q7 GMP ManufacturedActive Drug Substance
URIDINE, API, LBLE 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. Uridine is intended to be used as an Active Pharmaceutical Ingredient in oral and parenteral drug formulations.
Product Specifications
| ANALYSIS | SPECIFICATIONS | ||
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≤ 100 ppm |
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White Crystalline Powder |
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≤ 2 ppm |
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97 – 102% (on anhydrous) |
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≤ 0.5 EU/mg |
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≥ 99.0% |
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≤ 10 ppm |
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Positive |
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Positive |
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≤ 1000 ppm |
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Melting Point |
167° - 170°C |
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| pH of solution (5%, water) | 4.0 – 6.0 | ||
| Phosphates | ≤ 1000 ppm | ||
| Purity (HPLC) |
≥ 97% (main peak area %) |
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≤ 0.5% ≤ 2% ≤ 0.3% ≤ 0.1% ≤ 3.0% |
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| Transmittance of solution (5%, water) |
≥ 95.0% |
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| Water Content (KF) | ≤ 1.0% |
| Key Compliance Attributes of BioSpectra Grades | Bio Active Grade ICH Q7 Compliant Manufactured | ||
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| indicates 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. |
| List of C of As files |
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| No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
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