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Pharma Stability: Insights, Guidelines, and Expertise

Tag: Stability Specifications

Evaluate Visible and Sub-Visible Particulates in Injectable Stability Testing

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Understanding the Tip: Why particulate testing is essential in injectables: Particulate matter refers to extraneous particles—either visible to the naked eye or sub-visible (less than 100 μm)—that may be present in injectable products. Even minimal amounts can trigger severe adverse effects like embolism or inflammatory reactions when administered intravenously. Monitoring particulate levels is thus a…

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