Undesired
particle
in liquid
formulation
Particles in liquid formulation is a concern, critical for injectable but also parenteral and per os.
Also called unexpected, undissolved or undesired particles, they can be of different nature:
– Exogenous as dust, metal particles, joint particles (e.g. silicone/PTFE)
– Also, endogenous to the solution as the API can precipitate/recrystallize.