ASTM_E_2503_-_13e1.pdf

Designation:E2503131Standard Practice forQualification of Basket and Paddle Dissolution Apparatus1This standard is issued under the fixed designation E2503;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1NOTEEditorial corrections made throughout in April 2015.1.Scope1.1 This practice covers the set-up and calibration of thepaddle and basket dissolution apparatus.1.2 Use of this practice may be applied to apparatus thathave been modified to enable automatic dissolution testing(that is,a valve in the bottom of the vessel or sampling throughthe shaft).1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Significance and Use2.1 This practice outlines a procedure for the mechanicalcalibration of paddle and basket dissolution units to ensurereproducibility of results.2.2 Once a unit meets all of the mechanical specificationsincluded in this practice,it is considered calibrated and furthercalibration with dissolution calibrator tablets is not required.3.Analyst Responsibilities3.1 Verify the vessel,basket,and paddle dimensions onreceipt through measurement or Certificate of Analysis(COA)or Certificate of Conformity(COC).3.2 Ensure the instrument is calibrated and fit for perform-ing dissolution analysis.4.Procedure4.1 BackgroundThe set-up,mechanical,and operationalchecks are used to minimize variability during dissolutiontesting to ensure the reproducibility of dissolution results.4.2 Wherever possible,tools shall be traceable to an ac-cepted standard calibration source from a national or interna-tional calibration laboratory.4.3 Apparatus Set-upDuring apparatus installation or afterreplacement of parts or components,verify that the descriptionand critical dimensions for each part meets the originaldescription and dimension.4.3.1 Vessel DimensionsIn the absence of a COAor COC,the vessels internal dimensions should be measured with anappropriate measuring device and vessel shape and conditionshould be noted.For example,for a cylindrical,hemisphericalvessel,the vessels sides must be cylindrical,the internaldimension should be measured,and the vessel bottom shouldbe smooth and without defects.The vessel must fit within theapparatus in such a manner as to ensure stable operation andcentering of the shaft in the vessel.4.3.2 Basket/Shaft DimensionsIn the absence of a COAorCOC,an appropriate measuring device is used to measure therelevant basket dimensions.Critical dimensions to be mea-sured on each basket should include but are not limited to:shaftdiameter,vent hole diameter,thickness of wide portion of thebasket-to-shaft adaptor,total basket height,internal diameter atthe top of the basket,outer diameter of the screen,height of theopen screen,outer diameter of bottom,diameter of screen onthe bottom,and screen mesh number.4.3.3 Paddle DimensionsIn the absence of a COA orCOC,an appropriate measuring device is used to measure therelevant dimensions of the paddle.Examples of dimensions tobe determined on each paddle should include but are notlimited to:shaft diameter,blade height,blade thickness,totalblade length,length of flat portion on bottom of blade,radiusof the angle on the top outer edge of the top of the blade,radiusof the outside edge of the blade,difference between thedistance from the midline of the shaft to the top outer edge forthe two sides,and difference between the heights of both sidesof the paddles at the outside top.4.4 MaintenanceConsult the manufacturers maintenancerecommendations and maintenance schedule to establish anappropriate maintenance program based on the frequency ofapparatus use and quality system requirements.1This practice is under the jurisdiction of ASTM Committee E55 on Manufac-ture of Pharmaceutical Products and is the direct responsibility of SubcommitteeE55.03 on General Pharmaceutical Standards.Current edition approved Feb.1,2013.Published March 2013.Originallyapproved in 2007.Last previous edition approved in 2007 as E2503 07.DOI:10.1520/E2503-13E01.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.5 Mechanical CalibrationPerform these tests on thefrequency determined by the quality system or after repair ormove.If the instrument is not in routine use,the mechanicalcalibration may be performed before performing the firstdissolution test.Some instrument manufacturers supply specialtools or incorporate automatic mechanical calibratio