Day 1 - US Pharmacopeial Convention

Introduction
Impurities are unwanted chemicals which may
affect efficacy and safety of the pharmaceutical
products
As per the US Federal Register (Vol. 65, No.
251): Any component of the new ‘Drug
Substance’ (Active Pharmaceutical Ingredients-
API) or ‘drug drug product’ product (Finished dose) that is not
the chemical entity or an excipient defined as
impurity
3