氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399362993691936389353593617936220.07
215.459397793878939280.08
单位质量响应值RSD%判断
6083.306079.480.05数据可信
供试品溶液-GF9440批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187224-8722492.97792.841.9892.9892.841.98
286346-8634692.04192.04
385904-8590491.57091.57
490277-9027796.23296.23
587369-8736993.13293.13
685473-8547391.11191.11
10min192904-9290499.03298.841.9899.1999.001.98
290201-9020196.15196.30
391010-9101097.01397.17
495046-95046101.315101.48
594135-94135100.344100.50
693060-9306099.19899.35
15min194230-94230100.445100.051.45100.77100.371.45
291994-9199498.06298.38
392608-9260898.71699.03
495596-95596101.901102.23
594889-94889101.148101.47
693825-93825100.014100.33
20min194634-94634100.876100.621.62101.36101.111.62
292139-9213998.21698.69
393195-9319599.34299.82
496455-96455102.817103.32
595168-95168101.445101.94
694790-94790101.042101.53
30min193569-9356999.741100.501.57100.40101.151.57
292761-9276198.87999.52
392968-9296899.10099.74
496662-96662103.038103.71
594898-94898101.157101.82
694813-94813101.067101.72
45min194014-94014100.215100.441.73101.04101.261.73
292573-9257398.67999.48
392339-9233998.43099.24
496683-96683103.060103.90
594852-94852101.108101.94
694861-94861101.118101.94
极限194271-94271100.489100.091.48101.48101.071.48
292021-9202198.09199.06
392744-9274498.86199.83
496005-96005102.337103.35
594153-94153100.363101.36
694164-94164100.375101.36
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.331744401747031744501741831743321744220.11
211.301746031746041746040.01
单位质量响应值RSD%判断
15394.7015451.680.27数据可信
供试品溶液-GF9440批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183125-8312544.51841.743.6544.5241.743.65
277604-7760441.56241.56
376528-7652840.98540.99
477348-7734841.42441.42
578404-7840441.99041.99
674646-7464639.97739.98
10min1140591-14059175.29573.092.2975.3773.162.29
2133796-13379671.65671.72
3134218-13421871.88271.95
4135089-13508972.34872.42
5140320-14032075.15075.22
6134871-13487172.23172.30
15min1162996-16299687.29485.651.4787.4985.841.47
2157587-15758784.39784.59
3159454-15945485.39785.59
4158477-15847784.87485.06
5162700-16270087.13587.33
6158319-15831984.78984.98
20min1174766-17476693.59792.261.4893.9492.591.48
2168843-16884390.42590.75
3171635-17163591.92192.25
4172829-17282992.56092.89
5175332-17533293.90194.24
6170226-17022691.16691.49
30min1181562-18156297.23796.280.7597.7496.760.75
2178001-17800195.33095.81
3179245-17924595.99696.48
4180372-18037296.60097.09
5180685-18068596.76797.26
6178734-17873495.72396.20
45min1186673-18667399.97498.111.16100.6498.761.16
2181017-18101796.94597.58
3181932-18193297.43598.08
4184749-18474998.94499.59
5182776-18277697.88798.55
6182006-18200697.47598.11
极限1186633-18663399.95398.261.20100.7899.071.19
2181263-18126397.07797.88
3182574-18257497.77998.59
4185780-18578099.496100.31
5182474-18247497.72698.55
6182081-18208197.51598.32
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399360593571932299319993558934320.22
215.459275492826927900.06
单位质量响应值RSD%判断
6070.966005.830.77数据可信
供试品溶液-GF9440批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186462-8646292.82492.491.5692.8292.491.56
287850-8785094.31494.31
383982-8398290.16190.16
486321-8632192.67392.67
585364-8536491.64591.65
686954-8695493.35293.35
10min193077-9307799.92699.691.14100.0899.841.14
294291-94291101.229101.39
391448-9144898.17798.33
491850-9185098.60898.76
593515-93515100.396100.55
692966-9296699.80799.96
15min195269-95269102.279101.930.99102.60102.250.99
295962-95962103.023103.35
394313-94313101.253101.57
493375-93375100.246100.56
595463-95463102.487102.81
695280-95280102.291102.61
20min195483-95483102.509102.171.05103.00102.661.05
295551-95551102.582103.08
394849-94849101.828102.31
493466-93466100.343100.83
596485-96485103.584104.08
695171-95171102.174102.67
30min194246-94246101.181101.720.84101.84102.380.84
295346-95346102.362103.03
395161-95161102.163102.82
493410-93410100.283100.94
595498-95498102.525103.19
694803-94803101.779102.44
45min195170-95170102.173102.040.95103.00102.880.95
295659-95659102.698103.54
395027-95027102.019102.84
493334-93334100.202101.02
595895-95895102.951103.79
695217-95217102.223103.06
极限195027-95027102.019101.751.29103.02102.761.28
295405-95405102.425103.44
394554-94554101.511102.50
492671-9267199.490100.48
596344-96344103.433104.44
694682-94682101.649102.65
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.331754671753341762521765051760761759270.29
211.301737741740571739160.12
单位质量响应值RSD%判断
15527.5415390.800.63数据可信
供试品溶液-GF9440批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179055-7905542.24139.186.1242.2439.186.11
277090-7709041.19141.19
371969-7196938.45538.45
473750-7375039.40639.41
566321-6632135.43735.44
671795-7179538.36238.36
10min1138108-13810873.79471.034.1173.8671.104.11
2140069-14006974.84274.91
3129116-12911668.98969.05
4134062-13406271.63271.70
5125952-12595267.29967.36
6130307-13030769.62669.69
15min1164990-16499088.15885.123.0488.3585.303.04
2165233-16523388.28888.48
3156521-15652183.63383.81
4158837-15883784.87085.06
5153393-15339381.96182.13
6156809-15680983.78683.97
20min1174815-17481593.40791.811.7893.7592.131.79
2176550-17655094.33494.67
3170047-17004790.86091.18
4170018-17001890.84491.17
5169495-16949590.56590.87
6169996-16999690.83291.15
30min1181526-18152696.99396.271.4597.4996.751.45
2184366-18436698.51199.01
3180996-18099696.71097.18
4177832-17783295.01995.50
5178122-17812295.17495.63
6178169-17816995.19995.67
45min1185791-18579199.27298.391.4299.9399.031.43
2187971-187971100.437101.10
3184926-18492698.81099.44
4180760-18076096.58497.22
5183236-18323697.90798.52
6182196-18219697.35197.98
极限1186514-18651499.65898.601.60100.4899.401.60
2188447-188447100.691101.52
3184475-18447598.56999.36
4180188-18018896.27897.08
5185186-18518698.94999.73
6182360-18236097.43998.23
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399307793153930069296592949930300.10
215.459293992835928870.08
单位质量响应值RSD%判断
6044.836012.100.39数据可信
供试品溶液-LC1771批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186036-8603692.51793.931.2792.5293.931.27
286975-8697593.52693.53
388192-8819294.83594.83
488896-8889695.59295.59
587671-8767194.27594.27
686318-8631892.82092.82
10min191664-9166498.56999.900.8598.72100.060.85
292255-9225599.20499.36
393471-93471100.512100.67
493684-93684100.741100.90
593276-93276100.302100.46
693077-93077100.088100.24
15min192874-9287499.870101.420.83100.19101.750.83
294144-94144101.235101.56
394645-94645101.774102.10
494501-94501101.619101.95
595134-95134102.300102.62
694617-94617101.744102.07
20min193205-93205100.226101.710.95100.71102.200.95
293817-93817100.884101.37
394911-94911102.060102.56
495499-95499102.692103.19
595289-95289102.467102.96
694778-94778101.917102.41
30min193191-93191100.211101.660.81100.86102.320.81
294171-94171101.264101.92
394720-94720101.855102.52
495361-95361102.544103.21
594946-94946102.098102.76
694855-94855102.000102.66
45min192927-9292799.927101.491.00100.75102.321.00
293746-93746100.807101.63
394657-94657101.787102.62
495069-95069102.230103.07
594332-94332101.437102.27
695547-95547102.744103.57
极限192677-9267799.658101.221.02100.64102.221.02
293295-93295100.322101.32
394150-94150101.242102.25
494825-94825101.968102.98
594955-94955102.107103.11
694884-94884102.031103.03
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.331744941746431745701745611745511745640.04
211.301751431748941750180.11
单位质量响应值RSD%判断
15407.2415488.320.38数据可信
供试品溶液-LC1771批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180513-8051343.05143.174.9743.0543.174.97
278751-7875142.10942.11
383997-8399744.91444.91
485900-8590045.93145.93
580749-8074943.17743.18
674475-7447539.82239.82
10min1131113-13111370.10770.362.8870.1870.432.88
2131474-13147470.30070.37
3134682-13468272.01672.09
4136120-13612072.78572.86
5130901-13090169.99470.07
6125193-12519366.94267.01
15min1157488-15748884.21085.031.6084.4085.221.61
2159825-15982585.46085.65
3160496-16049685.81986.01
4161022-16102286.10086.30
5160743-16074385.95186.14
6154535-15453582.63182.81
20min1169665-16966590.72191.861.1391.0592.191.14
2171008-17100891.43991.77
3172949-17294992.47792.82
4173954-17395493.01593.36
5173512-17351292.77893.11
6169660-16966090.71991.03
30min1177403-17740394.85996.260.9195.3496.750.91
2180377-18037796.44996.93
3181384-18138496.98897.48
4181458-18145897.02797.52
5180825-18082596.68997.18
6178735-17873595.57196.04
45min1179389-17938995.92197.780.9996.5698.430.99
2182555-18255597.61498.26
3183632-18363298.19098.84
4183917-18391798.34299.00
5183447-18344798.09198.74
6184286-18428698.53999.17
极限1180508-18050896.51997.970.9597.3298.780.95
2182937-18293797.81898.62
3183852-18385298.30799.12
4184419-18441998.61099.43
5185382-18538299.12599.94
6182228-18222897.43998.23
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399275692717925729258192521926290.11
215.459252292630925760.09
单位质量响应值RSD%判断
6018.785991.970.32数据可信
供试品溶液-LC1771批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186982-8698293.89393.630.8393.8993.630.83
286702-8670293.59193.59
385646-8564692.45192.45
486259-8625993.11393.11
587117-8711794.03994.04
687708-8770894.67794.68
10min191556-9155698.83198.412.7898.9998.562.78
292047-9204799.36199.52
386160-8616093.00693.16
491478-9147898.74798.90
593076-93076100.472100.63
692667-92667100.030100.19
15min192743-92743100.112100.461.18100.43100.781.18
293216-93216100.623100.94
391500-9150098.77099.08
492369-9236999.708100.03
594296-94296101.788102.11
694269-94269101.759102.08
20min193290-93290100.703101.021.22101.19101.501.22
293348-93348100.765101.25
391991-9199199.30099.77
493056-93056100.450100.94
594851-94851102.388102.88
694957-94957102.502103.00
30min192971-92971100.358100.751.48101.01101.411.48
292695-92695100.060100.72
391686-9168698.97199.61
492633-9263399.993100.65
595208-95208102.773103.44
694831-94831102.366103.03
45min193321-93321100.736100.841.22101.56101.671.22
293216-93216100.623101.45
391673-9167398.95799.76
492998-92998100.387101.21
594849-94849102.385103.22
694474-94474101.981102.82
极限192804-92804100.178100.411.12101.17101.401.12
292874-92874100.253101.25
391487-9148798.75699.73
492567-9256799.922100.91
594333-94333101.828102.83
694026-94026101.497102.50
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.331741581741771742111746381746791743730.16
211.301739801740991740400.05
单位质量响应值RSD%判断
15390.3815401.770.06数据可信
供试品溶液-LC1771批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182623-8262344.32742.534.2244.3342.534.22
279778-7977842.80142.80
382760-8276044.40144.40
478934-7893442.34842.35
573827-7382739.60839.61
677704-7770441.68841.69
10min1135510-13551072.70169.512.9372.7869.582.93
2131159-13115970.36770.44
3129493-12949369.47369.55
4130178-13017869.84169.91
5126201-12620167.70767.77
6124863-12486366.98967.06
15min1159806-15980685.73683.911.6885.9384.101.69
2157982-15798284.75784.95
3157609-15760984.55784.75
4156329-15632983.87184.06
5153111-15311182.14482.32
6153551-15355182.38082.56
20min1171157-17115791.82691.000.6792.1691.320.68
2169272-16927290.81591.14
3170126-17012691.27391.60
4169722-16972291.05691.38
5167715-16771589.97990.29
6169668-16966891.02791.35
30min1177729-17772995.35295.200.5695.8495.680.55
2175804-17580494.31994.80
3177937-17793795.46395.95
4177911-17791195.44995.93
5176771-17677194.83895.30
6178484-17848495.75796.23
45min1180950-18095097.08096.910.3597.7397.540.35
2180284-18028496.72297.36
3180750-18075096.97297.61
4180846-18084697.02497.66
5179561-17956196.33596.96
6181362-18136297.30197.93
极限1180967-18096797.08996.860.4497.9097.660.44
2180062-18006296.60397.40
3181155-18115597.19097.99
4180799-18079996.99997.80
5179148-17914896.11396.90
6181088-18108897.15497.95
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