Uracil

BIO PHARMA GRADE / UC4202

C of As and Tech Docs

FOR USE IN PHARMACEUTICAL GMP PROCESSES

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BIO PHARMA GRADE | UC4202

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  
97.0-102.0%
Identification (IR)  
Passes Test
Reaction  
Passes Test
Solubility  
Passes Test
TAMC

Alert Limit

Release Limit

100 CFU/g max.

1000 CFU/g max.
Printable Version
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
List of C of As files
UC4202-006-0620.pdf
UC4202-004-0420.pdf

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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The manufacturing of Uracil UC4202 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of UC4202 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 UC4202 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 UC4202 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 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.