Page 78 - Quality control of pharmaceuticals (07-PA 704)
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2. Olymorphic Impurities
3. Genotoxic Impurities
ORGANIC IMPURITIES (Process and Drugrelated)
Organic impurities may arise during the manufacturing process and/ or storage of
the drug substance, these are described as follows:
a) Starting materials or intermediates
b) By-products
c) Degradation products
d) Reagents, ligands and catalysts
e) Impurities originated from reaction solvents
a. Starting materials or intermediates:
During multistep synthesis process there are high changes of impurities formed as
by products, intermediates are produced.
For examples:
In paracetamol bulk, there is a limit test for p-aminophenol, which could be a
starting material for some one manufacturer or be an intermediate for the other.
