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Particulate Impurities

Meaning

Particulate Impurities refers to extraneous, mobile, undissolved substances, excluding gas bubbles, that are unintentionally present in parenteral (injectable) drug products, including sterile hormone and peptide preparations. These impurities are typically microscopic, inert particles originating from the manufacturing environment, raw materials, or packaging components, such as glass fragments, rubber stopper residue, or fiber. The presence of particulate impurities is a critical pharmaceutical quality control issue, as they pose a non-negligible risk of vascular occlusion and local tissue reaction upon injection.