2005-4137B1_06_Criteria.doc

2005-4137B1_06_Criteria.doc - Calibration Criteria USP JP...

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Calibration Criteria CHEMICAL CALIBRATION / CALIBRATOR TABLETS USP JP BP EP PhRMA FDA/DPA Calibrator Tablets 6 Non Disintegrating, App. 1 6 Non Disintegrating, App.2 6 Disintegrating, App.1 6 Disintegrating, App 2 None None None In House Calibrator MECHANICAL CALIBRATION TOLERANCES, APPARATUS 1 (BASKET) AND APPARATUS 2 (PADDLE) Calibration Parameter USP JP BP EP PhRMA Proposed DPA Vessel dimensions (Inspect at time of receipt only) Internal diameter 98-106 mm External Height 160-210mm Hemispherical bottom, 1000ml Internal diameter 98-106 mm Internal height 160-175 mm Round bottom, 1000ml Internal diameter 98-106 mm Internal height 160-176 mm Hemispherical bottom, 1000ml Internal diameter 98-106 mm Internal height 160-176 mm Hemispherical bottom, 1000ml Same as USP Same as USP Basket dimensions (Inspect at time of receipt only) Conforms to diagram in USP Mesh Size 0.40 +/- 0.04mm Conforms to diagram in JP (Almost identical to USP) Mesh Size 0.425mm Same as EU Conforms to diagram in EU (Almost identical to USP) Mesh Size 0.381mm Same as USP Same as USP
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