What are the main sections of USP <1787>?

FAQs Standards

There are three main sections: Size and Distribution, Size and Morphology and Characterization.

Each provides a description as well as the advantages/disadvantages of various techniques. Particle categories are also defined and covered.

Type Origin Definition Examples


External to the process Material not part of the formulation, package or assembly process Glass, stopper fragments, metals, silicon oil, filter/process particles, clothing or hair fibers, skin flakes, dirt particles
Intrinsic Part of the process or product itself Material from sources involved in formulation, packaging or assembly processes Active ingredients, ingredient degradation, protein aggregation, ingredient anomalies, other process-related particles
Inherent Part of the formulation Material expected from drug substances and formulation components Certain excipients, mannitol crystallization, proteinaceous aggregates, adjunctive material in suspension