All dissolution testing laboratories are mandated by FDA to calibrate and qualify the apparatus based on a standardized written procedure. Because the EMC does not include PVT using USP Prednisone Tablets RS, it requires additional checks and stricter criteria for some parameters (e.g., two-point vessel-centering check with acceptance criterion of 1.0 mm) (3-5). FDA has published guidance for enhanced mechanical calibration (EMC) of dissolution apparatus (2) that can be utilized alternatively to calibrate the dissolution apparatus to similar standards but without the need to perform dissolution testing with reference prednisone tablets.
Usp calculation tool verification#
USP Performance Verification Tests (PVTs) have served as the industry standard for the performance check of USP dissolution Apparatus 1 and 2 (1). KEYWORDS: Dissolution vessel centering enhanced mechanical calibration FDA ASTM prednisone tablets USP PVT acceptance criteria.
An ad hoc policy allowing no investigation for centering values greater than 1.0 mm but less than 1.5 mm during calibration might be suitable for routine maintenance of dissolution Apparatus 1 and 2. The data indicate that a stricter alignment practice might be necessary during calibration and routine use to ensure vessel centering is maintained per the FDA criteria. The PVT results failed at 2.0-mm centering condition. The test results passed Stage 1 at nominal and 1.0-mm centering conditions and passed the 1.5-mm condition at Stage 2. Dissolution testing was carried out using USP Prednisone Tablets RS, and the geometric mean and %CV were calculated using the PVT calculation tool and template and assigned pass/fail criteria based on the USP acceptance criteria. Experiments were conducted by manually adjusting vessels to varying degrees of off-center. We attempted to design a practical approach to evaluate a critical tolerance range around the acceptance criteria. However, the impact of off-centered vessels on drug release and dissolution has not been evaluated. The FDA/ASTM criterion for vessel centering is 1.0 mm. Vessel-centering determination carried out as a part of Enhanced Mechanical Calibration is the most sensitive parameter to vessel inconsistencies and therefore tightly controlled.
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