What are the main sections of USP <1787>?
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 |
|---|---|---|---|
|
Extrinsic |
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 |
