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Impurities

 
Organic Impurities : Process | Drug Related
Organic impurities can arise during the manufacturing process and/or storage of the API.

They can be, identified or unidentified, volatile or non volatile, and include:
Starting Materials, By-Products, Intermediates, Degradation Products, Reagents, Ligands and Catalysts.
 
Inorganic Impurities :
Inorganic impurities can result from the manufacturing process, they are normally known and identified and include, Reagents, ligands, catalysts, Heavy metals or other residual metals, Inorganic salts, Other materials- e.g. filter aids, charcoal.
 
Residual Solvents :
Solvents are organic or inorganic liquids used during manufacturing process.
 
Extraneous Contaminants : Polymorphic Forms | Enantiomeric Impurities
Extraneous Contaminants should not occur in new drug substances and are more appropriately addressed as GMP issues.
 
 
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