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%
110.158416784185841398421084214841830.04
210.258409284165841280.07
单位质量响应值RSD%判断
8293.898207.610.74数据可信
供试品溶液-24090401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%
5min186457-8645794.122103.834.8094.12103.824.81
297283-97283105.908105.91
399559-99559108.386108.39
496866-96866105.454105.45
596729-96729105.305105.30
695332-95332103.784103.78
10min186815-8681594.512104.024.7094.67104.194.70
297777-97777106.446106.62
399519-99519108.342108.52
497205-97205105.823106.00
596573-96573105.135105.31
695386-95386103.843104.02
15min186725-8672594.414103.974.7494.73104.324.74
297704-97704106.366106.72
399445-99445108.262108.62
497477-97477106.119106.47
596382-96382104.927105.28
695298-95298103.747104.09
20min192432-92432100.627104.952.47101.10105.472.48
297772-97772106.440106.97
399343-99343108.151108.69
497188-97188105.804106.33
596491-96491105.046105.57
695213-95213103.654104.17
30min193889-93889102.213104.981.81102.85105.671.82
297453-97453106.093106.80
398790-98790107.549108.27
497089-97089105.697106.40
596174-96174104.701105.40
695182-95182103.621104.31
45min194449-94449102.823104.901.71103.63105.771.73
297378-97378106.011106.90
398727-98727107.480108.38
496965-96965105.562106.44
595938-95938104.444105.32
694710-94710103.107103.97
极限190536-9053698.563103.982.9999.54105.032.99
296942-96942105.537106.60
398826-98826107.588108.67
496697-96697105.270106.33
595729-95729104.216105.27
694363-94363102.729103.77
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%
113.931053691055871055811052501049291053430.26
213.991054411053181053800.09
单位质量响应值RSD%判断
7562.317532.520.28数据可信
供试品溶液-24090401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%
5min1112277-11227796.44994.492.0696.4594.492.06
2107886-10788692.67792.68
3113005-11300597.07497.07
4108878-10887893.52993.53
5107642-10764292.46792.47
6110300-11030094.75194.75
10min1112048-11204896.25294.302.3396.4194.462.33
2107749-10774992.55992.71
3112903-11290396.98797.15
4110010-11001094.50294.66
5106118-10611891.15891.31
6109840-10984094.35694.51
15min1111329-11132995.63594.341.9395.9694.661.93
2108735-10873593.40693.72
3112708-11270896.81997.14
4110128-11012894.60394.92
5106616-10661691.58691.89
6109441-10944194.01394.33
20min1109226-10922693.82893.681.8394.3194.151.83
2107709-10770992.52592.99
3112395-11239596.55097.04
4109450-10945094.02194.49
5106476-10647691.46691.92
6109038-10903893.66794.14
30min1109576-10957694.12993.621.9894.7794.251.98
2107347-10734792.21492.83
3112017-11201796.22696.87
4109690-10969094.22794.85
5105778-10577890.86691.48
6109492-10949294.05794.68
45min1111439-11143995.72993.941.8896.5294.721.88
2108310-10831093.04193.81
3111451-11145195.73996.55
4109681-10968194.21995.00
5106023-10602391.07791.84
6109206-10920693.81194.60
极限1109650-10965094.19293.252.0495.1594.192.03
2107317-10731792.18893.12
3111935-11193596.15597.12
4108976-10897693.61394.56
5105447-10544790.58291.50
6107991-10799192.76793.71
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%
110.158455284443845268452984548845200.06
210.258404084086840630.04
单位质量响应值RSD%判断
8327.098201.271.08数据可信
供试品溶液-24090402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%
5min196512-96512104.901103.242.89104.90103.242.89
297192-97192105.640105.64
398263-98263106.804106.80
491260-9126099.19399.19
593811-93811101.965101.97
692889-92889100.963100.96
10min196804-96804105.218103.922.78105.39104.092.78
298161-98161106.693106.87
398524-98524107.088107.27
491914-9191499.903100.07
594665-94665102.893103.06
693576-93576101.710101.88
15min196602-96602104.999103.642.60105.35103.982.61
297538-97538106.016106.37
398166-98166106.699107.06
491876-9187699.862100.19
594435-94435102.643102.98
693476-93476101.601101.94
20min196641-96641105.041103.502.80105.57104.022.80
297518-97518105.994106.53
398345-98345106.893107.43
491790-9179099.769100.27
594119-94119102.300102.81
692914-92914100.990101.50
30min196243-96243104.609103.322.77105.31104.012.77
297463-97463105.935106.64
398026-98026106.547107.26
491225-9122599.15499.82
593835-93835101.991102.67
693563-93563101.696102.37
45min196211-96211104.574103.112.87105.45103.972.87
297274-97274105.729106.61
397909-97909106.419107.31
490917-9091798.82099.65
593872-93872102.032102.88
692983-92983101.065101.91
极限196188-96188104.549103.122.70105.60104.162.70
297088-97088105.527106.59
397632-97632106.118107.19
491177-9117799.102100.10
594430-94430102.638103.66
692713-92713100.772101.79
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%
113.931058981058601065801060541062481061280.28
213.991054321053981054150.03
单位质量响应值RSD%判断
7618.667535.030.79数据可信
供试品溶液-24090402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%
5min1111932-11193295.78295.571.8595.7895.571.85
2108574-10857492.90892.91
3112379-11237996.16496.16
4114888-11488898.31198.31
5111564-11156495.46795.47
6110801-11080194.81494.81
10min1112699-11269996.43896.202.1196.6096.362.11
2108953-10895393.23393.39
3112389-11238996.17396.33
4116319-11631999.53699.70
5112610-11261096.36296.52
6111568-11156895.47095.63
15min1112858-11285896.57496.122.2196.8996.442.21
2109089-10908993.34993.66
3112337-11233796.12896.45
4116457-11645799.65499.98
5112606-11260696.35896.68
6110631-11063194.66894.99
20min1112412-11241296.19296.052.2396.6796.532.23
2109190-10919093.43593.90
3112851-11285196.56897.05
4116427-11642799.628100.12
5112322-11232296.11596.60
6110261-11026194.35294.83
30min1112527-11252796.29195.631.9496.9396.271.94
2109194-10919493.43994.06
3111361-11136195.29395.93
4115448-11544898.79099.45
5111807-11180795.67596.32
6110170-11017094.27494.91
45min1111512-11151295.42295.162.1296.2295.962.12
2108302-10830292.67593.45
3111339-11133995.27496.07
4115345-11534598.70299.53
5110979-11097994.96695.77
6109789-10978993.94894.74
极限1111793-11179395.66395.222.1796.6296.172.17
2108341-10834192.70993.64
3111294-11129495.23696.20
4115286-11528698.65299.64
5111600-11160095.49896.46
6109303-10930393.53294.48
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%
110.158395183970839948396483921839600.04
210.258405683998840270.05
单位质量响应值RSD%判断
8271.928197.760.64数据可信
供试品溶液-24090403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%
5min199636-99636108.678107.673.02108.68107.673.02
2103103-103103112.460112.46
3100687-100687109.825109.82
497589-97589106.446106.45
595546-95546104.217104.22
695699-95699104.384104.38
10min1100366-100366109.475108.462.97109.66108.642.97
2103604-103604113.006113.19
3101555-101555110.772110.95
498566-98566107.511107.69
596335-96335105.078105.25
696204-96204104.935105.11
15min1100130-100130109.217108.272.96109.58108.642.96
2103509-103509112.903113.28
3101212-101212110.397110.77
498546-98546107.489107.85
596197-96197104.927105.28
696003-96003104.716105.06
20min199666-99666108.711108.072.92109.26108.612.93
2103363-103363112.744113.31
3101053-101053110.224110.78
498323-98323107.246107.78
596188-96188104.917105.44
695869-95869104.569105.09
30min199728-99728108.779107.882.86109.51108.602.86
2103148-103148112.509113.26
3100543-100543109.668110.40
498201-98201107.113107.83
595801-95801104.495105.19
696027-96027104.742105.44
45min199389-99389108.409107.542.81109.32108.442.81
2102731-102731112.054112.99
3100207-100207109.301110.22
497906-97906106.791107.68
595565-95565104.238105.11
695739-95739104.428105.30
极限199413-99413108.435107.442.82109.52108.522.82
2102513-102513111.816112.94
3100285-100285109.386110.49
497670-97670106.534107.60
596022-96022104.736105.78
695111-95111103.743104.79
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%
113.931050931049931052061050151056351051880.26
213.991053371053441053400.01
单位质量响应值RSD%判断
7551.187529.660.21数据可信
供试品溶液-24090403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%
5min1108613-10861393.38894.401.8393.3994.401.83
2111103-11110395.52995.53
3109803-10980394.41194.41
4106984-10698491.98791.99
5109457-10945794.11494.11
6112801-11280196.98996.99
10min1109961-10996194.54795.361.4194.7095.511.41
2111971-11197196.27596.43
3110505-11050595.01595.17
4108724-10872493.48393.64
5111095-11109595.52295.68
6113165-11316597.30297.46
15min1109315-10931593.99195.231.3394.3095.551.33
2111234-11123495.64195.96
3110242-11024294.78995.10
4109525-10952594.17294.48
5110919-11091995.37195.69
6113322-11332297.43797.76
20min1109425-10942594.08695.211.3194.5695.681.31
2111303-11130395.70196.18
3110273-11027394.81595.29
4109451-10945194.10894.57
5110654-11065495.14395.62
6113285-11328597.40597.89
30min1108749-10874993.50594.891.5794.1395.521.57
2111564-11156495.92596.56
3109645-10964594.27594.91
4109128-10912893.83194.45
5109815-10981594.42195.05
6113283-11328397.40398.05
45min1108332-10833293.14694.371.3993.9395.161.39
2110060-11006094.63295.43
3109303-10930393.98194.77
4108419-10841993.22194.00
5109927-10992794.51895.31
6112482-11248296.71597.53
极限1109160-10916093.85894.361.1594.8095.311.15
2110005-11000594.58595.54
3109417-10941794.07995.02
4108220-10822093.05093.98
5109670-10967094.29795.25
6111989-11198996.29197.26
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