USP <1086> - Impurities in Drug Substances and Drug Products

What it says

This general information chapter describes how impurities in drug substances and drug products are classified, such as organic and inorganic impurities and residual solvents, how they arise, and how they are evaluated and controlled, in line with the ICH framework for impurities.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It gives a compendial companion to the ICH Q3 impurity guidelines.
• Controlling impurities relies on understanding where they come from, whether from synthesis, degradation or storage.
• Methods used to detect impurities must be suitable and validated.

What inspectors look for

• Whether impurity profiles are characterized and controlled by specifications.
• Whether methods are validated to detect impurities at the needed levels.
• Whether new or increased impurities are investigated.

Related regulations