Definition:
Impurity is defined as any component of the drug substance that is not the chemical entity defined as the new drug substance.
Classification:
Impurity is defined as any component of the drug substance that is not the chemical entity defined as the new drug substance.
Classification:
Impurities can be
classified into the following categories:
•
Organic impurities (It may be process and drug related)
•
Inorganic impurities
• Residual solvents
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