Pharmaceutical Impurity Analysis –
Overview and Regulatory Situation
Pharmaceutical impurities are the unwanted chemicals that remain with active
pharmaceutical ingredients (APIs) or drug product formulations. The impurities
observed in drug substances may arise during synthesis, or may be derived from
sources such as starting materials, intermediates, reagents, solvents, catalysts,
and reaction by-products. During drug product development, impurities may:
• Be formed as a result of the inherent instability of drug substances
• Be due to incompatibility with added excipients, or
• Appear as the result of interactions with packaging materials and container
closure systems (CCSs)
The amount of various impurities found in drug substances determines the
ultimate safety of the final pharmaceutical product. Therefore, the identification,
quantitation, qualification, and control of impurities are a critical part of the drug
development process.
Various regulatory authorities focus on the control of impurities:
• The International Council for Harmonisation (ICH)
• The United States Food and Drug Administration (USFDA)
• The European Medicines Agency (EMA)
• The Canadian Drug and Health Agency
• The Japanese Pharmaceutical and Medical Devices Agency (PMDA)
• The Australian Department of Health and Ageing Therapeutic Goods
In addition, several official compendia, such as the British Pharmacopoeia (BP),
the United States Pharmacopeia (USP), the Japanese Pharmacopoeia (JP), the
European Pharmacopoeia (EP), and the Pharmacopoeia of the People’s Republic
of China (ChP) are incorporating limits that restrict the impurity levels present in APIs and drug formulations. The regulations are based on exposure limits,
so the level of contaminants must be controlled in the final dosage form, as
administered. In practice, this means that drug manufacturers must perform a
risk assessment that takes into consideration sources of contamination postmanufacturing—such as packaging, transportation, and CCS, as well as from raw materials and manufacturing processes.
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