URACIL, LBLE GMP Grade

BIO PHARMA GRADE / UC4250

FOR USE IN PHARMACEUTICAL GMP PROCESSES EXCIPIENT / GMP INTERMEDIATE

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BIO PHARMA GRADE | UC4250

CAS #: 66-22-8

Molecular Formula:

C4H4N2O2

F.W.: 112.09 g/mol

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.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

ANALYSIS SPECIFICATIONS
Appearance and Color  
White to Slightly Yellow Powder
Assay  
≥ 98%
Chlorides  
≤ 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)
Reaction  
Passes Test
Residue on Ignition  
≤ 0.10%
Solubility  
Passes Test
Sulphates  
≤ 400 ppm
TAMC  
≤ 100 CFU/g
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Excipient 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
IPEC cGMP Compliant Manufactured  
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

Yes-imageindicates 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 Excipient
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 UC4250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of UC4250 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
  • Uracil is a white to off-white 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 UC4250 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; 2,4-Pyrimidinediol.


GMP Compliance:

Bio Pharma Grade Uracil UC4250 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.

Expiration/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.