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.
|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|