Particulates in parenterals

摘要

Paniculate matter is a key indicator of quality for injectable drug products. An undissolved particle, other than gas bubbles, unintentionally present in a drug product solution is defined in United States Pharmacopeia (USP) as foreign particulate matter.1 Particulates are considered to be a broad category of material that can be either intrinsic to the drug product or extrinsic, which may result from the manufacturing process.