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Fill Volume and Its Impact on Potency Testing for IV Bags

 

Potency testing measures the concentration of the active pharmaceutical ingredient (API) in a drug product. This critical test should be conducted before drug distribution, confirming that the API concentration is within specification of the labeled amount. 

USP 797 Category 2 CSP Testing

USP 797 Category 2 CSP Testing

USP 797 Pharmaceutical Compounding - Sterile Preparations outlines the minimum standards for preparing compounded sterile preparations (CSPs) for human and animal medications. These standards are designed to ensure the quality of CSPs and to minimize potential harm to patients.

Sterility Testing for Antibiotics

Potency and Stability Differences

Labeling Compounded Preparations

Sterility Testing Options

Active Pharmaceutical Ingredient Testing

Sterility and Endotoxin