系列解读 | 数值修约、处理与报告的原则集合( 二 ) ：系列解读|数值修约、处理与

备注：应当参考最新版药典凡例。
*【USP】GenaralNotices-7.20.RoundingRules
1)Theobservedorcalculatedvaluesshallberoundedofftothenumberofdecimalplacesthatisinagreementwiththelimitexpression.
Numbersshouldnotberoundeduntilthefinalcalculationsforthereportablevaluehavebeencompleted.
Intermediatecalculations(e.g.,slopeforlinearity)mayberoundedforreportingpurposes,buttheoriginal(notrounded)valueshouldbeusedforanyadditionalrequiredcalculations.Acceptancecriteriaarefixednumbersandarenotrounded.
2)Whenroundingisrequired,consideronlyonedigitinthedecimalplacetotherightofthelastplaceinthelimitexpression.
Ifthisdigitissmallerthan5,itiseliminatedandtheprecedingdigitisunchanged.Ifthisdigitisequaltoorgreaterthan5,itiseliminatedandtheprecedingdigitisincreasedby1.

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解读：
1)读到的或计算出的数值要修约至与限度一样的小数位数。
2)数值必须在最后计算得出可报告数值后才进行修约。
3)中间计算值（如线性斜率）作报告时可进行修约，但是如果进行下一步计算时必须使用原始（未修约）的数值。验收标准是固定的数值，不可以进行修约。
4)修约时，仅考虑限度值最后小数位后面的一位数字。如果小于5 ，则舍去且前面数字不变；如果大于或等于5 ，则进一位。
备注：应当参考最新版药典凡例。
*【ICHQ3A（A2）】REPORTINGIMPURITYCONTENTOFBATCHES
批（产品）杂质含量的报告
Analyticalresultsshouldbeprovidedintheapplicationforallbatchesofthenewdrugsubstanceusedforclinical,safety,andstabilitytesting,aswellasforbatchesrepresentativeoftheproposedcommercialprocess.Quantitativeresultsshouldbepresentednumerically,andnotingeneraltermssuchas“complies”,“meetslimit”etc.
Anyimpurityatalevelgreaterthan(>)thereportingthreshold(seeAttachment1)andtotalimpuritiesobservedinthesebatchesofthenewdrugsubstanceshouldbereportedwiththeanalyticalproceduresindicated.Below1.0%,theresultsshouldbereportedtotwodecimalplaces(e.g.,0.06%,0.13%);atandabove1.0%,theresultsshouldbereportedtoonedecimalplace(e.g.,1.3%).Resultsshouldberoundedusingconventionalrules(seeAttachment2).
Atabulation(e.g.,spreadsheet)ofthedataisrecommended.Impuritiesshouldbedesignatedbycodenumberorbyanappropriatedescriptor,e.g.,retentiontime.Ifahigherreportingthresholdisproposed,itshouldbefullyjustified.Allimpuritiesatalevelgreaterthan(>)thereportingthresholdshouldbesummedandreportedastotalimpurities.
ATTACHMENT2
IllustrationofReportingImpurityResultsforIdentificationandQualificationinanApplication
在（注册）申请中报告杂质结果以进行识别和鉴定的（举例）说明
Theattachmentisonlyillustrativeandisnotintendedtoserveastemplatehowresultsonimpuritiesshouldbepresentedinanapplicationfile.Normallyrawdataarenotpresented.
附件只是（举例）说明，并不是作为模板（如何在应用文件中显示杂质的结果）。通常不提供原始数据。
Example1:
0.5gMaximumDailyDose
Reportingthreshold=0.05%
Identificationthreshold=0.10%
Qualificationthreshold=0.15%

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Example2:
0.8gMaximumDailyDose
Reportingthreshold=0.05%
Identificationthreshold=0.10%
Qualificationthreshold=1.0mgTDI

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1)Afteridentification,iftheresponsefactorisdeterminedtodiffersignificantlyfromtheoriginalassumptions,itmaybeappropriatetore-measuretheactualamountoftheimpuritypresentandre-evaluateagainstthequalificationthreshold(seeAttachment1).
识别后，如果确定的响应因子与原假设有显著差异，则可能需要重新测量杂质的实际存在量，并根据限定阈值重新评估（见附件1）。
2)Toverifyifathresholdisexceeded,areportedresulthastobeevaluatedagainstthethresholdsasfollows:whenthethresholdisdescribedin%,thereportedresultroundedtothesamedecimalplaceasthethresholdshouldbecompareddirectlytothethreshold.WhenthethresholdisdescribedinTDI,thereportedresultshouldbeconvertedtoTDI,roundedtothesamedecimalplaceasthethresholdandcomparedtothethreshold.
Forexampletheamountofimpurityat0.12%levelcorrespondstoaTDIof0.96mg(absoluteamount)whichisthenroundedupto1.0mg;sothequalificationthresholdexpressedinTDI（1.0mg）isnotexceeded.
为了验证是否超过阈值，必须根据阈值对报告的结果进行如下评估：当阈值用%表示时，报告的结果四舍五入到与阈值相同的小数点后，直接与阈值进行比较。当在TDI中描述阈值时，报告的结果应该转换为TDI ，四舍五入到与阈值相同的小数点位置，并与阈值进行比较。
例如，杂质含量为0.12%时， TDI为0.96mg（绝对含量），然后四舍五入为1.0mg；因此， TDI（1.0mg）所表示的合格阈值没有被超过。