current Good Analytical Laboratory Practices (cGALP)

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Uniformity of dosage unit calculation Tool - USP
 
This tool assists in the understanding of the revised Uniformity of Dosage Units test as defined in General Chapter <905>. The spreadsheet allows the input of data particular to a product and provides pass/fail interpretation. For download calculator click CompendialCalculator.xls

PVT calculation tool
 
USP recently posted a page on the subject of performance of disolution equipment. It assure that performance of dissolution equipment by giving procedure for mechanical calibration, performance verification test using prednisone tablet and further assist manufacturers and others wishing to assure the integrity of the USP Pefrormance test, USP will provide a validated, web–based tool for use in conducting the calculations necessary to evaluate the results of a PVT. Users can enter data from a PVT, and the tool will calculate results automatically. USP offers the Web–based tool as a convenient option and not as a requirement. All equations used in the Web tool are included in the USP certificate. 
 
Dissolution Apparatus Performance Verification Test(PVT) Calculation Tool - USP
 
This calculation tool allows the evaluation of the performance of a dissolution assembly by comparing the results obtained from the PVT to limits given in the Acceptance Criteria for PVT Tablets. For download calculation tool click Dissolution apparatus

 

 
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