培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411615801624941634871634151631651628280.50
216.471627621628191627900.03
单位质量响应值RSD%判断
9922.499884.030.28数据可信
加速6月-供试品溶液-2023110721批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149404-4940431.11741.3121.3331.1241.3121.33
282242-8224251.80051.80
367484-6748442.50442.50
476290-7629048.05148.05
569907-6990744.03144.03
648206-4820630.36230.36
10min1146780-14678092.44994.693.0692.5794.863.05
2147887-14788793.14693.35
3154276-15427697.17097.34
4153978-15397896.98297.17
5144252-14425290.85691.03
6154894-15489497.55997.68
15min1157692-15769299.32298.862.6799.8299.402.66
2154443-15444397.27597.86
3157786-15778699.38199.94
4164059-164059103.332103.91
5151586-15158695.47696.02
6156167-15616798.36198.87
20min1160662-160662101.19299.292.65102.08100.242.64
2154780-15478097.48798.46
3157441-15744199.164100.12
4164216-164216103.431104.42
5152742-15274296.20497.13
6156056-15605698.29199.20
30min1160768-160768101.25999.452.42102.56100.792.41
2154465-15446597.28998.65
3157869-15786999.433100.79
4164026-164026103.311104.72
5155039-15503997.65198.96
6155242-15524297.77899.08
45min1160199-160199100.90199.242.09102.60100.972.08
2154095-15409597.05698.80
3157053-15705398.919100.67
4162611-162611102.420104.24
5154682-15468297.42699.12
6156700-15670098.697100.39
60min1158841-158841100.04598.622.34102.15100.762.33
2153549-15354996.71298.85
3155560-15556097.979100.13
4162987-162987102.657104.89
5154262-15426297.16199.25
6154306-15430697.18999.27
极限1159209-159209100.27798.522.44102.78101.052.43
2153130-15313096.44898.97
3156008-15600898.261100.80
4162709-162709102.482105.12
5153750-15375096.83999.31
6153741-15374196.83399.31
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.302976892987023007792987552986922989230.38
212.352986152994362990260.20
单位质量响应值RSD%判断
24302.6824212.630.27数据可信
加速6月-供试品溶液-2023110721批-吲达帕胺-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133704-3370410.91514.5419.0610.9214.5419.06
252882-5288217.12617.13
347981-4798115.53915.54
453051-5305117.18117.18
546676-4667615.11615.12
635021-3502111.34211.34
10min1121684-12168439.40843.895.7139.4543.955.73
2141925-14192545.96346.03
3140174-14017445.39645.46
4141141-14114145.71045.78
5136278-13627844.13544.20
6131921-13192142.72442.77
15min1177776-17777657.57460.383.2057.7860.623.21
2190526-19052661.70361.96
3187539-18753960.73660.98
4194592-19459263.02063.27
5182251-18225159.02359.26
6185973-18597360.22960.45
20min1212263-21226368.74369.792.5669.1770.272.57
2218307-21830770.70071.20
3214244-21424469.38569.87
4224046-22404672.55973.06
5207860-20786067.31767.79
6216332-21633270.06170.52
30min1247451-24745180.13980.082.1180.8580.842.12
2249941-24994180.94581.73
3243041-24304178.71179.47
4254933-25493382.56283.36
5240104-24010477.76078.50
6248167-24816780.37181.11
45min1273601-27360188.60887.402.1389.6388.472.11
2273023-27302388.42189.53
3264530-26453085.67086.75
4274533-27453388.91090.03
5260816-26081684.46785.52
6272651-27265188.30089.36
60min1287381-28738193.07191.112.3794.4592.532.34
2284389-28438992.10293.56
3273563-27356388.59590.02
4286960-28696092.93494.41
5272436-27243688.23089.62
6283201-28320191.71793.13
极限1302763-30276398.05295.172.1999.8196.962.17
2295115-29511595.57597.40
3287029-28702992.95794.73
4298335-29833596.61898.47
5286150-28615092.67294.42
6293789-29378995.14696.92
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411616731623431624421622761624441622360.20
216.471620001619211619600.04
单位质量响应值RSD%判断
9886.419833.640.38数据可信
加速6月-供试品溶液-2023110821批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146984-4698429.72340.7231.2929.7240.7231.29
297216-9721661.50061.50
357286-5728636.24036.24
453384-5338433.77133.77
550299-5029931.82031.82
681047-8104751.27151.27
10min1152891-15289196.72096.712.1196.8496.872.13
2155852-15585298.59398.84
3149086-14908694.31394.46
4156259-15625998.85198.99
5148974-14897494.24294.37
6154164-15416497.52697.73
15min1154929-15492998.01098.431.5598.5298.981.58
2158259-158259100.116100.76
3151369-15136995.75796.28
4157391-15739199.567100.10
5155427-15542798.32598.83
6156153-15615398.78499.38
20min1155950-15595098.65598.521.4799.5599.461.49
2158134-158134100.037101.08
3151577-15157795.88996.79
4157382-15738299.561100.49
5155506-15550698.37599.27
6155870-15587098.60599.60
30min1155459-15545998.34598.361.6599.6499.701.67
2158268-158268100.122101.56
3150788-15078895.39096.68
4157072-15707299.365100.69
5155346-15534698.27399.56
6155972-15597298.669100.05
45min1154550-15455097.77098.001.5299.4699.731.55
2157521-15752199.649101.49
3150732-15073295.35497.02
4156708-15670899.135100.86
5154946-15494698.02099.70
6155009-15500998.06099.84
60min1154223-15422397.56397.291.4799.6499.411.48
2155750-15575098.529100.77
3149892-14989294.82396.87
4156140-15614098.776100.90
5153110-15311096.85998.94
6153609-15360997.17599.35
极限1153415-15341597.05297.391.6599.5299.901.67
2156964-15696499.297101.93
3149509-14950994.58197.01
4155501-15550198.371100.89
5153742-15374297.25999.72
6154567-15456797.781100.34
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.302978282988992985532988122988082985800.15
212.352981752980352981050.04
单位质量响应值RSD%判断
24274.8024138.060.40数据可信
加速6月-供试品溶液-2023110821批-吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134772-3477211.28514.4623.1711.2914.4623.17
259272-5927219.23619.24
342882-4288213.91713.92
436856-3685611.96111.96
538142-3814212.37912.38
655364-5536417.96817.97
10min1124764-12476440.49144.907.6940.5444.967.71
2149723-14972348.59248.67
3139498-13949845.27345.33
4135701-13570144.04144.09
5129371-12937141.98742.04
6151090-15109049.03549.11
15min1178183-17818357.82860.813.2258.0461.053.25
2194478-19447863.11763.39
3187849-18784960.96561.20
4184946-18494660.02360.25
5185360-18536060.15860.38
6193399-19339962.76763.03
20min1208630-20863067.71069.431.6868.1569.911.72
2216681-21668170.32370.85
3214384-21438469.57770.06
4211516-21151668.64669.11
5213732-21373269.36669.82
6218677-21867770.97071.49
30min1239707-23970777.79679.251.1978.5080.011.23
2246169-24616979.89380.70
3245128-24512879.55580.31
4241677-24167778.43579.17
5245147-24514779.56180.30
6247352-24735280.27781.08
45min1261069-26106984.72985.830.7885.7586.910.80
2265067-26506786.02687.15
3266243-26624386.40887.48
4263196-26319685.41986.47
5266572-26657286.51487.57
6264670-26467085.89787.02
60min1272751-27275188.52088.860.7489.8890.280.73
2272574-27257488.46289.93
3277639-27763990.10691.53
4272459-27245988.42589.82
5274405-27440589.05790.46
6273052-27305288.61890.09
极限1284742-28474292.41192.130.8494.1293.900.82
2282850-28285091.79793.62
3287507-28750793.30995.09
4280440-28044091.01592.76
5284648-28464892.38194.14
6283070-28307091.86993.69
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411619541620831618391617241621241619450.11
216.471615811616741616280.05
单位质量响应值RSD%判断
9868.689813.480.40数据可信
加速6月-供试品溶液-2023110822批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116124-11612473.60344.8431.8073.6044.8431.80
264102-6410240.63040.63
354975-5497534.84534.84
463075-6307539.97939.98
563574-6357440.29540.29
662595-6259539.67439.67
10min1158265-158265100.31394.438.13100.6194.618.15
2153111-15311197.04697.21
3125007-12500779.23379.37
4152915-15291596.92297.08
5155278-15527898.42098.58
6149366-14936694.67294.83
15min1159074-159074100.82699.071.83101.5299.631.88
2158007-158007100.149100.70
3151047-15104795.73896.19
4155737-15573798.71099.26
5156255-15625599.03999.59
6157712-15771299.962100.50
20min1158106-158106100.21299.070.91101.31100.020.97
2156519-15651999.206100.16
3154289-15428997.79398.63
4155520-15552098.57399.52
5155768-15576898.73099.68
6157618-15761899.903100.84
30min1157601-15760199.89298.990.71101.39100.330.77
2156326-15632699.084100.43
3154931-15493198.20099.43
4155335-15533598.45699.79
5155511-15551198.56799.91
6157317-15731799.712101.05
45min1158544-158544100.49099.250.98102.39100.991.02
2157292-15729299.696101.44
3155890-15589098.807100.43
4154519-15451997.93899.67
5155512-15551298.568100.31
6157748-15774899.985101.72
60min1157941-157941100.10798.810.77102.41100.950.84
2155781-15578198.738100.88
3154837-15483798.140100.16
4155385-15538598.487100.61
5154833-15483398.137100.27
6156559-15655999.231101.37
极限1156887-15688799.43998.230.86102.14100.760.90
2155297-15529798.432100.97
3154611-15461197.997100.41
4152847-15284796.87999.39
5154695-15469598.050100.58
6155514-15551498.569101.10
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.302984212983692977362983362985212982770.11
212.352978372974342976360.10
单位质量响应值RSD%判断
24250.1624100.080.44数据可信
加速6月-供试品溶液-2023110822批-吲达帕胺
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170938-7093823.05215.9422.9023.0515.9422.89
245431-4543114.76314.76
339866-3986612.95512.96
442170-4217013.70413.70
549543-4954316.10016.10
646454-4645415.09615.10
10min1159607-15960751.86744.349.6551.9644.409.67
2137475-13747544.67544.73
3120464-12046439.14739.20
4129015-12901541.92541.98
5138980-13898045.16445.23
6133116-13311643.25843.32
15min1203282-20328266.06060.784.6966.3661.024.72
2185970-18597060.43460.67
3178933-17893358.14758.36
4180031-18003158.50458.73
5188378-18837861.21661.46
6185673-18567360.33760.57
20min1227880-22788074.05369.793.3774.6270.273.40
2213120-21312069.25769.74
3209187-20918767.97968.42
4207471-20747167.42167.88
5214814-21481469.80770.30
6216007-21600770.19570.67
30min1257027-25702783.52579.962.4484.3880.722.47
2243728-24372879.20379.96
3245335-24533579.72580.44
4239304-23930477.76578.49
5243602-24360279.16279.93
6247276-24727680.35681.11
45min1276912-27691289.98786.912.3591.1887.992.36
2263500-26350085.62886.70
3271465-27146588.21789.25
4260067-26006784.51385.55
5263330-26333085.57386.66
6269369-26936987.53688.61
60min1289032-28903293.92590.382.3895.4891.812.40
2273933-27393389.01990.43
3282414-28241491.77593.16
4272807-27280788.65390.03
5272176-27217688.44889.88
6278363-27836390.45891.89
极限1298320-29832096.94493.502.8098.8795.292.80
2282660-28266091.85593.63
3296614-29661496.38998.14
4281152-28115291.36593.09
5279713-27971390.89792.68
6287921-28792193.56495.35
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