INTRODUCTION

Parenteral products are designed and manufactured to minimize particulate matter, which is differentiated into two broad categories: visible and subvisible. The absolute limit of visibility, or detectability, depends on the test conditions and the nature of the particulate matter. This general information chapter covers subvisible particles in the range of 2–100 µm. Particles larger than 100 µm are generally considered visible particles (see Visible Particulates in Injections 〈790〉).