比索洛尔氨氯地平片项目信息
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10071-202203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2000
标示量(mg)5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%
110.178518385209850618509685370851840.15
210.108528785120852040.14
单位质量响应值RSD%判断
8376.018436.040.51数据可信
中间条件36月-供试品溶液-2022110111批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193101-9310199.48198.781.2299.4898.781.22
291012-9101297.24997.25
393374-9337499.77399.77
492502-9250298.84198.84
591111-9111197.35597.36
693553-9355399.96499.96
10min193612-93612100.02899.901.20100.19100.061.20
291830-9183098.12398.29
393948-93948100.387100.55
492962-9296299.33399.50
593367-9336799.76699.93
695221-95221101.747101.91
15min193374-9337499.77399.071.18100.1199.401.18
291261-9126197.51597.84
393459-9345999.864100.20
492661-9266199.01199.34
591573-9157397.84998.18
693966-93966100.406100.74
20min192939-9293999.30898.821.3599.8199.311.35
290743-9074396.96297.45
393459-9345999.864100.36
492687-9268799.03999.53
591195-9119597.44597.94
693854-93854100.286100.79
30min193127-9312799.50998.731.36100.1799.391.36
290636-9063696.84897.50
393472-9347299.878100.54
492370-9237098.70099.36
591158-9115897.40598.06
693644-93644100.062100.73
45min192802-9280299.16298.631.3699.9999.451.36
290642-9064296.85497.67
393427-9342799.830100.66
492386-9238698.71799.54
590932-9093297.16497.98
693613-93613100.029100.87
极限192486-9248698.82498.351.3799.8299.341.37
290397-9039796.59297.56
393109-9310999.490100.49
492107-9210798.41999.41
590683-9068396.89897.88
693453-9345399.858100.86
比索洛尔氨氯地平片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921042391041861042261041661043871042410.09
213.901046061043121044590.20
单位质量响应值RSD%判断
7488.587515.040.25数据可信
中间条件36月-供试品溶液-2022110111批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198720-9872085.31984.342.4885.3284.342.48
294107-9410781.33281.33
398048-9804884.73884.74
4100353-10035386.73086.73
599073-9907385.62485.62
695205-9520582.28182.28
10min1112464-11246497.19796.551.2897.3496.701.28
2112676-11267697.38097.52
3111666-11166696.50796.65
4111127-11112796.04196.19
5113168-11316897.80597.95
6109215-10921594.38994.53
15min1111600-11160096.45095.201.1196.7595.511.11
2110766-11076695.72996.03
3110394-11039495.40895.71
4109076-10907694.26994.57
5110790-11079095.75096.06
6108330-10833093.62493.92
20min1110383-11038395.39894.820.9595.8695.280.95
2109757-10975794.85795.31
3110474-11047495.47795.94
4108952-10895294.16294.62
5110701-11070195.67396.14
6108040-10804093.37393.82
30min1110994-11099495.92694.581.4096.5595.201.40
2109073-10907394.26694.88
3110414-11041495.42596.05
4108996-10899694.20094.82
5110387-11038795.40296.03
6106769-10676992.27592.88
45min1109315-10931594.47593.901.2095.2694.671.20
2108908-10890894.12494.90
3109569-10956994.69595.47
4108196-10819693.50894.28
5109660-10966094.77495.56
6106234-10623491.81392.57
极限1109372-10937294.52593.571.2995.4794.501.29
2108236-10823693.54394.47
3108891-10889194.10995.05
4107422-10742292.83993.77
5109701-10970194.80995.75
6105953-10595391.57092.48
比索洛尔氨氯地平片项目信息
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10071-202203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2000
标示量(mg)5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%
110.178504185117851118510985130851020.05
210.108531485386853500.06
单位质量响应值RSD%判断
8367.948450.500.70数据可信
中间条件36月-供试品溶液-2022110211批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192660-9266098.97499.131.8498.9799.131.84
292351-9235198.64498.64
391111-9111197.31997.32
492773-9277399.09499.09
596046-96046102.590102.59
691889-9188998.15098.15
10min192781-9278199.10399.511.7999.2799.681.79
292480-9248098.78298.95
391848-9184898.10698.27
492896-9289699.22699.39
596468-96468103.041103.21
692498-9249898.80198.96
15min192590-9259098.89999.381.8099.2399.721.80
292476-9247698.77799.11
391710-9171097.95998.28
492718-9271899.03699.37
596378-96378102.945103.29
692397-9239798.69399.02
20min192285-9228598.57399.111.7999.0799.611.79
292237-9223798.52299.02
391446-9144697.67798.17
492632-9263298.94499.44
596087-96087102.634103.15
692061-9206198.33498.83
30min191980-9198098.24798.922.1798.9199.582.17
291864-9186498.12498.78
391175-9117597.38898.04
492398-9239898.69499.35
596628-96628103.212103.90
691628-9162897.87198.53
45min192046-9204698.31899.061.8599.1499.891.84
291887-9188798.14898.97
391385-9138597.61298.43
493835-93835100.229101.05
595737-95737102.260103.12
691578-9157897.81898.64
极限191946-9194698.21198.591.8099.2099.581.80
291705-9170597.95498.94
391036-9103697.23998.22
491914-9191498.17799.17
595616-95616102.131103.16
691587-9158797.82898.81
比索洛尔氨氯地平片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921041691043491041251040921042491041970.10
213.901042931043981043460.08
单位质量响应值RSD%判断
7485.427506.910.21数据可信
中间条件36月-供试品溶液-2022110211批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192529-9252980.02883.894.0780.0383.894.07
293941-9394181.24981.25
398209-9820984.94184.94
4103745-10374589.72989.73
595960-9596082.99683.00
697570-9757084.38884.39
10min1110412-11041295.49596.431.3495.6396.571.34
2110420-11042095.50295.64
3112535-11253597.33197.47
4114055-11405598.64698.80
5110917-11091795.93296.07
6110627-11062795.68195.82
15min1109363-10936394.58895.361.3194.8895.661.31
2109247-10924794.48894.78
3110855-11085595.87896.18
4112916-11291697.66197.97
5109260-10926094.49994.80
6109882-10988295.03795.34
20min1107292-10729292.79794.941.8793.2595.401.87
2109614-10961494.80595.26
3110706-11070695.75096.21
4113269-11326997.96698.44
5108682-10868293.99994.45
6109065-10906594.33094.79
30min1106321-10632191.95793.741.7592.5694.361.75
2107247-10724792.75893.37
3109336-10933694.56595.19
4111574-11157496.50097.14
5108532-10853293.86994.48
6107264-10726492.77393.39
45min1107865-10786593.29293.361.3294.0594.141.30
2107926-10792693.34594.11
3110364-11036495.45496.23
4105909-10590991.60192.40
5107950-10795093.36694.13
6107661-10766193.11693.89
极限1107250-10725092.76093.811.3693.6794.741.36
2107936-10793693.35494.27
3109530-10953094.73295.67
4110967-11096795.97596.93
5107529-10752993.00293.93
6107571-10757193.03893.96
比索洛尔氨氯地平片项目信息
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10071-202203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2000
标示量(mg)5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%
110.178527685258852878521085164852390.07
210.108530085267852840.03
单位质量响应值RSD%判断
8381.428443.960.53数据可信
中间条件36月-供试品溶液-2022110311批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188802-8880294.81391.782.7294.8191.782.72
287598-8759893.52793.53
385783-8578391.58991.59
481995-8199587.54587.55
586424-8642492.27492.27
685190-8519090.95690.96
10min191246-9124697.42296.211.0997.5896.371.09
290642-9064296.77796.93
388893-8889394.91095.06
489014-8901495.03995.19
590044-9004496.13996.29
690848-9084896.99797.15
15min191580-9158097.77996.911.0998.1097.221.09
290943-9094397.09997.42
389617-8961795.68395.99
490223-9022396.33096.63
590047-9004796.14296.46
692200-9220098.44198.75
20min191740-9174097.95097.261.3698.4397.741.36
291154-9115497.32497.80
389778-8977895.85596.33
490881-9088197.03397.50
589922-8992296.00996.48
693111-9311199.41399.89
30min192102-9210298.33697.121.2098.9897.761.20
290842-9084296.99197.63
389691-8969195.76296.39
490861-9086197.01197.64
589921-8992196.00896.64
692351-9235198.60299.25
45min191536-9153697.73296.711.1598.5497.511.15
290607-9060796.74097.54
389561-8956195.62396.41
489900-8990095.98596.77
589772-8977295.84896.64
692102-9210298.33699.14
极限191297-9129797.47796.561.1098.4597.521.10
290601-9060196.73497.70
389347-8934795.39596.34
490017-9001796.11097.06
589540-8954095.60196.55
691840-9184098.05699.03
比索洛尔氨氯地平片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921043351042131043931041261040681042270.14
213.901044131042091043110.14
单位质量响应值RSD%判断
7487.577504.390.16数据可信
中间条件36月-供试品溶液-2022110311批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100054-10005486.53977.817.8486.5477.817.84
290042-9004277.87977.88
395162-9516282.30782.31
484429-8442973.02473.02
589564-8956477.46677.47
680541-8054169.66169.66
10min1107103-10710392.63585.076.1792.7885.206.17
299818-9981886.33586.46
3100690-10069087.08987.23
492655-9265580.13980.26
599585-9958586.13386.26
690251-9025178.06078.18
15min1110486-11048695.56189.124.6295.8689.394.62
2104099-10409990.03790.31
3103937-10393789.89790.18
498602-9860285.28385.54
5103985-10398589.93990.21
697130-9713084.01084.26
20min1112818-11281897.57891.883.7098.0492.303.71
2106993-10699392.54092.96
3106605-10660592.20592.64
4103328-10332889.37089.77
5106319-10631991.95792.38
6101300-10130087.61688.00
30min1114359-11435998.91194.692.4199.5395.262.42
2109567-10956794.76795.34
3109398-10939894.62095.21
4108681-10868194.00094.55
5108393-10839393.75194.33
6106483-10648392.09992.63
45min1115427-11542799.83596.032.28100.6296.762.28
2109844-10984495.00695.74
3111138-11113896.12596.87
4112124-11212496.97897.68
5108730-10873094.04394.77
6108892-10889294.18394.87
极限1113798-11379898.42695.402.0799.3896.292.08
2109255-10925594.49795.39
3111488-11148896.42897.33
4111181-11118196.16397.03
5107804-10780493.24294.13
6108270-10827093.64594.49
比索洛尔氨氯地平片项目信息
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10071-202203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2000
标示量(mg)5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%
110.178507185090849558506685246850860.13
210.108532685247852860.07
单位质量响应值RSD%判断
8366.378444.160.66数据可信
中间条件36月-供试品溶液-5543C0421批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191692-9169297.98696.272.6097.9996.272.60
286937-8693792.90492.90
391614-9161497.90297.90
487650-8765093.66693.67
592650-9265099.00999.01
689977-8997796.15396.15
10min193734-93734100.16898.932.14100.3399.092.14
290330-9033096.53096.68
394126-94126100.587100.75
490437-9043796.64496.80
594964-94964101.482101.65
691862-9186298.16798.33
15min193800-93800100.23899.071.86100.5799.401.86
290663-9066396.88697.20
394000-94000100.452100.78
490931-9093197.17297.49
594763-94763101.267101.60
692094-9209498.41598.74
20min193779-93779100.21698.922.10100.7199.412.10
290416-9041696.62297.10
394014-94014100.467100.97
490228-9022896.42196.90
594803-94803101.310101.81
692147-9214798.47298.96
30min193611-93611100.03698.702.05100.7099.352.05
290340-9034096.54197.18
393855-93855100.297100.96
490114-9011496.29996.94
594477-94477100.962101.63
691744-9174498.04198.69
45min194098-94098100.55798.772.09101.3999.592.09
290303-9030396.50197.30
394389-94389100.868101.70
490580-9058096.79797.60
593999-93999100.451101.29
691188-9118897.44798.26
极限193228-9322899.62798.322.13100.6399.302.13
289874-8987496.04397.00
394025-94025100.479101.48
489906-8990696.07797.04
593938-93938100.386101.39
691066-9106697.31798.29
比索洛尔氨氯地平片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921038621039491038091039201037591038600.08
213.901041411041861041640.04
单位质量响应值RSD%判断
7461.217493.810.31数据可信
中间条件36月-供试品溶液-5543C0421批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195652-9565282.93681.103.9482.9481.103.94
289843-8984377.89977.90
391533-9153379.36479.36
489497-8949777.59977.60
596984-9698484.09184.09
697687-9768784.70084.70
10min1106585-10658592.41591.192.9892.5591.322.98
2102033-10203388.46988.60
3103574-10357489.80589.94
4101730-10173088.20688.34
5108795-10879594.33294.47
6108286-10828693.89094.03
15min1109822-10982295.22293.941.4395.5194.221.44
2107459-10745993.17393.45
3108355-10835593.95094.23
4105712-10571291.65991.93
5109480-10948094.92695.22
6109226-10922694.70595.00
20min1110207-11020795.55694.251.2896.0194.691.28
2108703-10870394.25294.68
3108890-10889094.41494.85
4106085-10608591.98292.41
5109196-10919694.67995.13
6109114-10911494.60895.06
30min1110386-11038695.71194.441.0096.3295.041.01
2109515-10951594.95695.55
3108446-10844694.02994.62
4107150-10715092.90593.49
5109171-10917194.65895.27
6108873-10887394.39995.01
45min1109167-10916794.65493.910.7695.4294.670.76
2108947-10894794.46395.21
3107935-10793593.58694.34
4106904-10690492.69293.43
5108553-10855394.12294.89
6108351-10835193.94794.72
极限1109203-10920394.68593.710.9295.6194.620.92
2108487-10848794.06594.97
3107753-10775393.42894.34
4106354-10635492.21593.11
5108654-10865494.20995.14
6107985-10798593.62994.56
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