與農(nóng)藥劑型相關(guān)的控制指標(biāo)

與農(nóng)藥劑型相關(guān)的掌握工程原藥technicalmaterial(TC)母藥technicalconcentrate(TK)Declaredcontenting/kgorg/lat20upto25above25upto100above100upto250above250upto500above500 upto900

Tolerance±15%ofthedeclaredcontentfor“homogeneous”formulations(EC,SC,SL,etc.),or±25%for“heterogeneous”formulations(GR,WG,etc.)±10%ofthedeclaredcontent±6%ofthedeclaredcontent±5%ofthedeclaredcontent±25g/kgorg/labove900upto1000 theminimumcontent,only,isdeclared.NoteIneachrangetheupperlimitisincluded粉劑〔DP〕DUSTABLEPOWDERS1)水分含量Water(MT30.5)Maximum: g/kg.test(MT59.1)Maximum:5%retainedona75μmtestsieve.3〕酸堿度〔以HSONaOH〕或pHAcidityand/orAlkalinity(MT191)orpHrange2 4(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......4〕其他Stabilityatelevatedtemperature(MT46.3)酸堿度〔以HSO

乳油(EC)Emulsifiableconcentrates1〕Water(MT30.5)Maximum: g/kg.NaOH〕或pHAcidityand/orAlkalinity(MT191)orpHrange2 4(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......乳液穩(wěn)定性Emulsionstabilityandre-emulsification(MT36.1.1,MT36.3orMT183)Timeafterdilution0h0.5h2.0h24h24.5h

Limitsofstability,MT36.1,MT36.3Initialemulsificationcomplete“Cream“,maximum: ml“Cream“,maximum: ml“Freeoil“,maximum: mlRe-emulsificationcomplete“Cream“,maximum: “Freeoil“,maximum: mlNote:inapplyingMT36.1or36.3,testsafter24harerequiredonlywhereresultsat2hareindoubtTimeafterdilution2min7to32min

Limitsofstability,MT183ACreadingmaximum......ACreadingsimilartoabove(nomajorincrease,declineorfluctuation)Note:inapplyingMT183,initialACreadingwillbe<1inmostcases其他Persistentfoam(MT47.2)(Note7)Maximum:......mlafter1min.StoragestabilityStabilityat0°C(MT39.3)Afterstorageat0±2°Cfor7days,thevolumeofsolidand/orliquidwhichseparatesshallnotbemorethan0.3ml.Stabilityatelevatedtemperature(MT46.3)Afterstorageat54±2°Cfor14days,thedeterminedaverageactiveingredientcontentmustnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:-acidity,alkalinity,pHrange,-emulsionstabilityandre-emulsification酸堿度(以HSO2 4

可濕性粉劑(WP)WETTABLEPOWDERS1〕水分含量Water(MT30.5)Maximum: g/kg.或NaOHpHAcidityand/orAlkalinity(MT191)orpHrange(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......懸浮率Suspensibility(MT15.1,MT177,MT184)(Notes5&6)Aminimumof......%ofthe......[ISOcommonname]contentshallbeinsuspensionafter30mininCIPACStandardWaterDat30±2°C.4〕潮濕時(shí)間Wettability(MT53.3)Theformulationshallbecompletelywettedin......minwithoutswirling.sievetest(MT185)Maximum:......%retainedona45μmtestsieve.6〕Stabilityatelevatedtemperature(MT46.3)Afterstorageat54±2°Cfor14days,thedeterminedaverageactiveingredientcontentmustnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:acidity/alkalinity/pHrange,wetsievetest,suspensibility,-wettability,Persistentfoam(MT47.2)Maximum:......mlafter1min.顆粒劑(GR)Granules1〕水分含量2〕松密度和堆密度〔視需要〕3〕酸堿度(以HSO或NaOHpH2 44〕粒度范圍5〕脫落率或強(qiáng)度6〕其他懸浮劑〔SC〕Aqueoussuspensionconcentrates酸堿度〔以HSONaOH〕或pHAcidityand/orAlkalinity(MT191)orpHrange2 4(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......濕篩試驗(yàn)〔75μm〕Wetsievetest(MT185)Maximum:......%oftheformulationshallberetainedona......μmtestsieve.懸浮率Suspensibility(MT184)Aminimumof......%ofthe......[ISOcommonname]contentshallbeinsuspensionafter30mininCIPACStandardWaterDat30±2°C.傾倒性Pourability(MT148.1)Maximum“residue“: %.Persistentfoam(MT47.2)(Note9)Maximum:......mlafter1min.*Spontaneityofdispersion(MT160)Aminimumof......%ofthe......[ISOcommonname]contentshallbeinsuspensionafter5mininCIPACStandardWaterDat30±2°C*Particlesizedistribution(MT187)…%ofparticlesshallbeintherange…to…*Viscosity(MT192)Theviscosityshallbeintherange…to….其他StoragestabilityStabilityat0°C(MT39.3)Afterstorageat0±2°Cfor7days,theformulationshallcontinuetocomplywithclausesfor:suspensibility,wetsievetest,Stabilityatelevatedtemperature(MT46.3)Afterstorageat54±2°Cfor14days(Note11),thedeterminedaverageactiveingredientcontentmustnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:-acidity/alkalinity/pHrange,-pourability,-spontaneityofdispersion,-suspensibility,-wetsievetest,水劑(AS)aqueoussolution1〕水不溶物含量2〕酸堿度(以HSO或NaOHpH2 4酸堿度(以HSO2 4

稀釋穩(wěn)定性其他可溶粉劑(SP)Watersolublepowders1〕Water(MT30.5)Maximum: g/kg.或NaOHpHAcidityand/orAlkalinity(MT191)orpHrange(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......3〕溶解程度和溶液穩(wěn)定性〔通過(guò)75μm〕Degreeofdissolutionandsolutionstability(MT179)Residueofformulationretainedona75μmtestsieveafterdissolutioninCIPACStandardWaterDat30±2°C:Maximum:......%after5min.Maximum:......%after18hours.4〕濕篩試驗(yàn)?5〕潤(rùn)濕時(shí)間Wettability(MT53.3)Theformulationshallbecompletelywettedin......minwithoutswirling.6〕長(zhǎng)久起泡性Persistentfoam(MT47.2)maximum:......mlafter minInthecaseofwatersolublebagpackaging,theprovisionsofclause6.21.6.4shouldbeapplied.7〕其他Stabilityatelevatedtemperature(MT46.3)Afterstorage54±2°Cfor14days,thedeterminedaverageactiveingredientcontentmustnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:-acidity/alkalinity/pHrange,-wettability,-degreeofdissolutionandsolutionstability,2HSO2 4

可溶粒劑(SG)Watersolublegranules1〕水分含量Water(MT30.5)Maximum: g/kg.或NaOHpHAcidityand/orAlkalinity(MT191)orpHrange(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......3〕長(zhǎng)久起泡性Persistentfoam(MT47.2)Ifrequired,maximummlafter1min.Inthecaseofwatersolublebagpackaging,theprovisionsofclause6.23.6.4shouldbeapplied.4〕溶解程度和溶液穩(wěn)定性〔通過(guò)75μm〕5〕濕篩試驗(yàn)Degreeofdissolutionandsolutionstability(MT179)Residueofformulationretainedona..μmtestsieveafterdissolutioninCIPACStandardWaterDat30±2°C.Maximum:......%after5min.Maximum:......%after18hours.*Dustiness(MT171)Essentiallynon-dusty*Attritionresistance(MT178.2)Minimum:......%attritionresistance.*Flowability(MT172)Atleast......%oftheformulationshallpassthrougha5mmtestsieveafter20dropsofthesieve.6〕其他Stabilityatelevatedtemperatures(MT46.3)Afterstorageat54±2°Cfor14daysthedeterminedaverageactiveingredientcontentshallnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:-acidity/alkalinity/pHrange,-degreeofdissolutionandsolutionstability,-dustiness,-attritionresistance,可溶片劑(ST)Watersolubletablets(1〕水分含量2〕酸堿度(以HSO或NaOHpH2 43〕長(zhǎng)久起泡性4〕崩解時(shí)間5〕溶解程度和溶液穩(wěn)定性〔75μm〕6〕濕篩試驗(yàn)7〕粉末和碎片8〕其他油劑(OL)Oilmiscibleliquids1〕水分含量2〕酸堿度(以HSO或NaOHpH2 43〕其他超低容量液劑(UL)Ultralowvolumeliquids1〕水分含量2〕酸堿度(以HSO或NaOHpH2 43〕揮發(fā)性4〕動(dòng)力粘度5〕其他煙片(FT)smoketablet水分含量或枯燥減量酸堿度(以HSO或NaOHpH2 43〕成煙率4〕自燃溫度燃燒發(fā)煙時(shí)間跌落裂開(kāi)率粉末和碎片點(diǎn)燃試驗(yàn)其他煙劑(FU)smokegenerator1〕水分含量或枯燥減量酸堿度(以HSO或NaOHpH2 43〕成煙率自燃溫度點(diǎn)燃試驗(yàn)燃燒發(fā)煙時(shí)間其他煙粉粒劑(FU)2〕酸堿度(以HSO或NaOHpH2 4酸堿度(以HSO2 4

3〕成煙率干篩試驗(yàn)自燃溫度點(diǎn)燃試驗(yàn)燃燒發(fā)煙時(shí)間其他水乳劑(EW)Emulsions,oilinwater或NaOHpHAcidityand/orAlkalinity(MT191)orpHrange(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......乳液穩(wěn)定性Emulsionstabilityandre-emulsification(MT36.1.1,MT36.3orMT183)Theformulation,whendilutedat30±2°CwithCIPACStandardWatersAandD,shallcomplywiththefollowingEC傾倒性Pourability(MT148.1)Maximum“residue“: %.Persistentfoam(MT47.2)Maximum:......mlafter1min.其他StoragestabilityStabilityat0°C(MT39.3)Afterstorageat0±2°Cfor7days,noseparationofparticulateoroilymattershallbevisibleaftergentleagitation.Stabilityatelevatedtemperature(MT46.3)Afterstorage54±2°Cfor14days,thedeterminedaverageactiveingredientcontentmustnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:-acidity/alkalinity/pHrange,-emulsionstabilityandre-emulsification,微乳劑(ME)Micro-emulsions1〕酸堿度(以HSO或NaOHpH2 4酸堿度〔以HSO

2〕乳液穩(wěn)定性透亮溫度范圍長(zhǎng)久起泡性其他懸乳劑〔SE〕Aqueoussuspo-emulsionsNaOH〕或pHAcidityand/orAlkalinity(MT191)orpHrange2 4(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......濕篩試驗(yàn)〔45μm〕Wetsievetest(MT185)Maximum:......g/kgoftheformulationshallberetainedona......μmtestsieve,atthedilutionsspecified.分散穩(wěn)定性Dispersionstability(MT180)Theformulation,whendilutedat30±2°CwithCIPACStandardWatersAandD,shallcontinuetocomplywiththefollowing:Timeafterallowingthedispersiontostand0h0.5h24h24.5h

LimitsofstabilityInitialdispersioncomplete“cream“,maximum: “freeoil“,maximum: mlsediment,maximum: mlRe-dispersioncomplete“cream“,maximum: “freeoil“,maximum: mlsediment,maximum: ml4〕傾倒性Pourability(MT148.1)Maximum“residue“: %.Persistentfoam(MT47.2)Maximum......mlafter1min.*Particlesizedistribution(MT187),…%ofparticlesshallbeintherange…to…*Viscosity(MT192),Theviscosityshallbeintherange…to….6〕其他StoragestabilityStabilityat0°C(MT39.3)Afterstorageat0±2°Cfor7days,theformulationshallcontinuetocomplywiththeclausesfor:acidity/alkalinity/pHrange,dispersionstability,-wetsievetest,Stabilityatelevatedtemperature(MT46.3)Afterstorageat54±2°Cfor14days,thedeterminedaverageactiveingredientcontentmustnotbelowerthan......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:acidity/alkalinity/pHrange,-pourability,dispersionstability,-wetsievetest,微囊懸浮劑〔CS〕Aqueouscapsulesuspensions1〕總有效成分含量2〕游離的有效成分含量或比值3〕酸堿度〔HSO2 4

NaOH〕或pH酸堿度(以HSO2 4

4〕篩析〔75μm〕5〕懸浮率6〕分散穩(wěn)定性7〕傾倒性8〕長(zhǎng)久起泡性9〕其他水分散粒劑(WG)Waterdispersiblegranules1〕水分含量Water(MT30.5)Maximum: g/kg.或NaOHpHAcidityand/orAlkalinity(MT191)orpHrange(MT75.3)Maximumacidity:......g/kgcalculatedasH2SO4.Maximumalkalinity:......g/kgcalculatedasNaOH.pHrange:......to......懸浮率Suspensibility(MT168,MT184)Aminimumof......%shallbeinsuspensionafter30mininCIPACStandardWaterDat30±2°C.Inthecaseofwatersolublebagpackaging,therequirementsofclause6.13.6.3shouldbeapplied.test(MT185)Maximum:......%retainedona75μmtestsieve.分散性Degreeofdispersion(MT174)Dispersibility:minimumafter1minuteofstirring.潮濕時(shí)間Wettability(MT53.3)Theformulationshallbecompletelywettedin min.長(zhǎng)久起泡性Persistentfoam(MT47.2)Maximum:......mlafter1minute.粒度范圍Flowability(MT172)Atleast......%oftheformulationshallpassthrougha5mmtestsieveafter20dropsofthesieve.*Dustiness(MT171)Essentiallynon-dusty.*Attritionresistance(MT178.2)Minimum:......%attritionresistance.Stabilityatelevatedtemperature(MT46.3)Afterstorageat54±2°Cfor14days,thedeterminedaverageactiveingredientcontentmustnotbelowerthat......%relativetothedeterminedaveragecontentfoundbeforestorageandtheformulationshallcontinuetocomplywiththeclausesfor:-by-productsofmanufactureorstorage,-acidity/alkalinity/pHrange,-wetsievetest,-degreeofdispersion-suspensibility-dustiness-attritionresistance,可分散片劑(WT)Waterdispersibletablets1〕水分含量酸堿度(以HSO或NaOHpH2 43〕崩解時(shí)間4〕懸浮率5〕濕篩試驗(yàn)長(zhǎng)久起泡性粉末和碎片其他可溶液劑〔SL〕Solubleconcentrates1〕水分含量Water(MT30.5)Maximum: g/kg.酸堿度(以HSO2 4

或NaOHpHAcidityand/orAlk