As per USP - United States Pharmacopeial the defination of an impurity is: 'any component of a drug substance that is not the chemical entity defined as the drug substance and in addition, for a drug product, any component that is not a formulation ingredient'
Presence of API related impurities, eg: degradation related impurities (DRI) and Interaction related impurities (IRI) can impact the safety, qualify and drug products efficacy.
Impurities in API's or drug doses may arise due to many conditions like: storage conditions, contamination, synthesis method etc. They can further be identified as volatile / non-volatile, organic / inorganic substances.
What are the classifications of Impurities?
As per the definitions of International Council for Harmonization (ICH), Food and Drug Administration (FDA), and USP, impurities are classified into 4 major classifications:
3. Residual solvents
4. Heavy metals
Clearsynth offers 21063 Impurity Standards for Reference Research: