Product Category

GMP Process Chemical

GMP Manufactured Product

URACIL, LBLE, ≥98%, GMP Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: URAC-4250 | Previously: UC4250

Intended For Use In Pharmaceutical GMP Processes

Uracil is important for the detoxification of many carcinogens and is also used to detoxify many drugs such as cannabinoids and opioids. Uracil can be used for drug delivery and as an intermediate to compounds used in anticancer drugs. Other derivatives are used in pesticides and antiphotosynthetic herbicides as well as in the synthesis of caffeine. Uracil is used as a coenzyme and allosteric regulator during biochemical reactions and for polysaccharide biosynthesis and transportation of sugars containing aldehydes.

Product Specifications

Appearance and Color  
White to Slightly Yellow Powder
≥ 98%
≤ 100 ppm 
Endotoxin content  
< 3 EU/g
Heavy Metals  
≤ 20 ppm
Identification (IR)  
Passes Test
Loss on Drying  
≤ 0.50%
Melting Point  
≥ 300 °C (Target 335 °C)
Passes Test
Residue on Ignition  
≤ 0.10%
Passes Test
≤ 400 ppm
≤ 100 CFU/g
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Each Batch 100% Analyzed  
Management of Change  
Validated Analytical Methods  
Compendial Testing  
Trace Metals Analyzed  
Stability Testing Program  
BioSpectra Supply Chain Audit Trail  
Product Origin Statement  
Customer Quality Audits  
Validated Manufacturing Process  
US Manufactured at BioSpectra  
IPEC cGMP Compliant Manufactured  
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Low Bioburden Low Endotoxin (LBLE)  
Enzyme Tested  
Suitable for use as Excipient  
Microbial / Endotoxin Tested  
Manufactured in FDA Registered Facility  
Customized Manufacturing Schedule  
Custom Regulatory Packet  
Accelerated Stability  
Video Conference access to BioSpectra Sites  
Complete access to Product Traceability  
Access to Supply Chain Information  

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical
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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General Product Description:

  • The manufacturing of Uracil URAC-4250 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of URAC-4250 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
  • Uracil is a white to slightly yellow powder.
  • Molecular Formula: C4H4N2O2
  • Molecular Weight: 112.09 g/mol.
  • CAS Number: 66-22-8.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Uracil URAC-4250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts. Uracil manufactured at BioSpectra and any raw materials used in the manufacture of Uracil at BioSpectra are not subject to genetic modification.
  • Synonyms: 2,4-Dihydroxypyrimidine; 2,4(1H,3H)-Pyrimidinedione;

GMP Compliance:

Bio Pharma Grade Uracil URAC-4250 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of Uracil is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

The recommended expiration period for Uracil is three years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.

Additional Packaging Information