USP pharmacopeia 791-pH 美国药典pH值_原创精品文档.pdf

USP pharmacopeia 791-pH 美国药典pH值_原创精品文档.pdf

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791pH

Forcompendialpurposes,pHisdefinedasthevaluegivenbyasuitable,properly

standardized,potentiometricinstrument(pHmeter)capableofreproducingpHvaluesto

0.02pHunitusinganindicatorelectrodesensitivetohydrogen-ionactivity,theglass

electrode,andasuitablereferenceelectrode.Theinstrumentshouldbecapableof

sensingthepotentialacrosstheelectrodepairand,forpHstandardizationpurposes,

applyinganadjustablepotentialtothecircuitbymanipulationof―standardization,‖

―zero,‖―asymmetry,‖or―calibration‖control,andshouldbeabletocontrolthechangein

millivoltsperunitchangeinpHreadingthrougha―temperature‖and/or―slope‖control.

Measurementsaremadeat25±2,unlessotherwisespecifiedintheindividual

monographorherein.

ThepHscaleisdefinedbytheequation:

pH=pHs+(E–ES)/k

inwhichEandEarethemeasuredpotentialswherethegalvaniccellcontainsthe

S

solutionundertest,representedbypH,andtheappropriateBufferSolutionfor

Standardization,representedbypHs,respectively.Thevalueofkisthechangein

potentialperunitchangeinpHandistheoretically[0.05916+0.000198(t–25)]voltsat

anytemperaturet.

ItshouldbeemphasizedthatthedefinitionsofpH,thepHscale,andthevaluesassigned

totheBufferSolutionsforStandardizationareforthepurposeofestablishingapractical,

operationalsystemsothatresultsmaybecomparedbetweenlaboratories.ThepH

valuesthusmeasureddonotcorrespondexactlytothoseobtainedbythedefinition,pH

=–logaH+.Solongasthesolutionbeingmeasuredissufficientlysimilarincomposition

tothebufferusedforstandardization,theoperationalpHcorrespondsfairlycloselyto

thet

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