Uracil-Excipient GMP Intermediate

BIO PHARMA GRADE / UC4220

FOR USE IN PHARMACEUTICAL GMP PROCESSES EXCIPIENT / GMP INTERMEDIATE

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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 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.

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BIO PHARMA GRADE / UC4220

CAS #: 66-22-8

Molecular Formula:

C4H4N2O2

F.W.: 112.09 g/mol

Key Compliance Attributes of
BioSpectra Grades
Bio Pharma
Grade IPEC
GMP
Compliant
Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
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General Product Description:

  • The manufacturing of Uracil UC4220 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of UC4220 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • Uracil is a White Crystalline product
  • 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 UC4220 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 UC4220 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 and IPEC compliant cGMP manufactured intermediate, process chemical and excipient for use in further Manufacturing. 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 retest period for Uracil is two years from the date of manufacture.

Storage and Shipping Conditions:

Ship and Store in ambient temperature.

Package Sizes:

10kg, 25kg and 50kg pails.