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APIs are used for different drug product dosage forms. The limits for particles might also take into account the route of administration, e.g.
・Tablets, capsules for oral applications: minute amounts of particles pass the
gastrointestinal tract unchanged;
・Solutions for parenteral, inhaler, ophthalmic applications: normally the solutions are
filtered by the drug product manufacturer via very small pore size. Minute amounts of
particles are generally removed by that filtration step. Related Drug Product (vials,
ampules, syringes, solutions) are tested for particulate matter during QC release
testing;
・Inhalers (dry form): a tighter limit might be applicable due to this specific dosage
form;