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)0
对照品批号100711-202203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%
19.998227782354823058227782282822990.04
29.958213682100821180.04
单位质量响应值RSD%判断
8238.148253.070.13数据可信
长期6月-供试品溶液-2024021621批-比索洛尔-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%
5min189098-8909897.05596.723.0397.0696.723.03
289286-8928697.26097.26
387934-8793495.78795.79
492644-92644100.918100.92
589419-8941997.40597.40
684356-8435691.89091.89
10min189795-8979597.81497.542.9897.9897.702.98
290055-9005598.09898.26
388585-8858596.49696.66
493477-93477101.825101.99
590117-9011798.16598.33
685247-8524792.86093.01
15min190761-9076198.86797.733.0099.1998.052.99
289996-8999698.03398.36
388519-8851996.42596.75
493542-93542101.896102.23
590078-9007898.12398.45
685401-8540193.02893.34
20min189560-8956097.55997.262.9498.0597.742.93
289687-8968797.69798.19
387999-8799995.85896.34
493309-93309101.642102.15
589837-8983797.86098.35
685304-8530492.92293.39
30min189150-8915097.11297.062.9997.7697.702.99
289558-8955897.55698.21
388173-8817396.04896.69
493093-93093101.407102.08
589753-8975397.76998.42
684868-8486892.44793.07
45min189145-8914597.10696.952.8797.9297.762.87
289462-8946297.45298.27
387892-8789295.74296.54
492920-92920101.219102.06
589520-8952097.51598.33
685083-8508392.68293.45
极限189068-8906897.02396.872.9398.0097.842.92
289378-8937897.36098.34
387996-8799695.85596.82
492799-92799101.087102.10
589532-8953297.52898.51
684769-8476992.34093.27
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)0
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%
113.549923699222991529889398782990570.21
213.519868498774987290.07
单位质量响应值RSD%判断
7315.887307.850.08数据可信
长期6月-供试品溶液-2024021621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%
5min1102918-10291891.24588.923.5691.2488.923.56
2101648-10164890.11990.12
394968-9496884.19684.20
4104566-10456692.70692.71
5100229-10022988.86188.86
697427-9742786.37686.38
10min1113965-113965101.03898.762.98101.1998.912.98
2112344-11234499.60199.75
3107221-10722195.05995.20
4116032-116032102.871103.03
5110011-11001197.53397.68
6108829-10882996.48596.63
15min1114108-114108101.16599.442.70101.4999.752.70
2112752-11275299.963100.28
3108180-10818095.91096.21
4116574-116574103.352103.68
5109726-10972697.28097.59
6111599-11159998.94199.25
20min1114243-114243101.28599.282.86101.7799.762.86
2112243-11224399.51299.99
3108022-10802295.77096.23
4116785-116785103.539104.04
5109462-10946297.04697.52
6111121-11112198.51798.99
30min1113946-113946101.02298.962.79101.6899.612.79
2110867-11086798.29298.94
3107344-10734495.16895.79
4116245-116245103.060103.73
5110005-11000597.52898.16
6111339-11133998.71099.34
45min1113739-113739100.83898.433.11101.6699.243.10
2111729-11172999.05699.87
3107488-10748895.29696.07
4115930-115930102.781103.62
5107339-10733995.16495.96
6109909-10990997.44398.24
极限1113887-113887100.96998.553.19101.9699.523.19
2111942-11194299.245100.22
3105528-10552893.55894.49
4115518-115518102.415103.43
5109197-10919796.81197.77
6110846-11084698.27399.23
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)0
对照品批号100711-202203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%
19.998227882220822888222182261822540.04
29.958229182268822800.02
单位质量响应值RSD%判断
8233.638269.350.31数据可信
长期6月-供试品溶液-2024021821批-比索洛尔-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%
5min188162-8816295.96797.381.9595.9797.381.95
292860-92860101.081101.08
389486-8948697.40997.41
488909-8890996.78196.78
589104-8910496.99396.99
688260-8826096.07496.07
10min189061-8906196.94698.701.9497.1198.861.94
294054-94054102.381102.55
390833-9083398.87599.04
489821-8982197.77397.93
590366-9036698.36798.53
689909-8990997.86998.03
15min188794-8879496.65598.551.9996.9898.881.99
293955-93955102.273102.61
390810-9081098.85099.18
489720-8972097.66397.99
590016-9001697.98698.31
689915-8991597.87698.20
20min188916-8891696.78898.561.9497.2799.051.94
293899-93899102.212102.72
390753-9075398.78899.28
489626-8962697.56198.05
590027-9002797.99898.49
690035-9003598.00698.49
30min189024-8902496.90698.631.9397.5599.281.92
293935-93935102.252102.93
390876-9087698.92299.58
489659-8965997.59798.25
590096-9009698.07398.72
690035-9003598.00698.66
45min188899-8889996.77098.541.9097.5899.361.89
293753-93753102.053102.90
390813-9081398.85399.67
489431-8943197.34998.16
590114-9011498.09298.91
690164-9016498.14798.96
极限188827-8882796.69198.311.9097.6699.301.90
293603-93603101.890102.91
390452-9045298.46099.45
489220-8922097.11998.09
589765-8976597.71298.69
690043-9004398.01598.99
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)0
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%
113.549900898916989259891298927989380.05
213.519899298965989780.02
单位质量响应值RSD%判断
7307.097326.280.19数据可信
长期6月-供试品溶液-2024021821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%
5min1104714-10471492.77690.593.8792.7890.593.87
2100816-10081689.32289.32
3102374-10237490.70390.70
4105041-10504193.06593.07
5105470-10547093.44693.45
695060-9506084.22284.22
10min1114015-114015101.01698.323.21101.1798.473.21
2108299-10829995.95296.10
3110493-11049397.89698.05
4112930-112930100.055100.21
5114565-114565101.504101.66
6105517-10551793.48793.63
15min1112195-11219599.40497.722.3799.7398.042.37
2107875-10787595.57695.89
3111398-11139898.69899.01
4110851-11085198.21398.53
5113081-113081100.189100.51
6106381-10638194.25394.55
20min1112353-11235399.54498.562.48100.0399.032.48
2109059-10905996.62597.09
3111823-11182399.07499.55
4112471-11247199.648100.13
5114732-114732101.652102.14
6107006-10700694.80695.26
30min1113200-113200100.29498.112.39100.9598.752.39
2107793-10779395.50496.13
3112169-11216999.381100.02
4111887-11188799.13199.78
5112373-11237399.562100.22
6106983-10698394.78695.40
45min1112390-11239099.57797.552.93100.4098.362.93
2108396-10839696.03896.83
3112062-11206299.286100.10
4107741-10774195.45896.27
5114162-114162101.147101.97
6105864-10586493.79594.56
极限1109748-10974897.23698.091.9298.2299.061.92
2108554-10855496.17897.13
3111717-11171798.98099.96
4110800-11080098.16899.14
5114350-114350101.313102.31
6109097-10909796.65997.58
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)0
对照品批号100711-202203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%
19.998273882777827588271882522827030.13
29.958229482412823530.11
单位质量响应值RSD%判断
8278.588276.680.02数据可信
长期6月-供试品溶液-2024022021批-比索洛尔-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%
5min193597-93597101.56199.782.59101.5699.782.58
290626-9062698.33898.34
395956-95956104.121104.12
489702-8970297.33597.34
590428-9042898.12398.12
691419-9141999.19899.20
10min194038-94038102.040100.602.45102.21100.762.45
291258-9125899.02399.19
396774-96774105.009105.18
491083-9108398.83499.00
591444-9144499.22599.39
691658-9165899.45799.62
15min193937-93937101.930100.592.46102.27100.932.46
291245-9124599.00999.34
396806-96806105.044105.39
491032-9103298.77899.11
591257-9125799.02299.35
691945-9194599.769100.10
20min193811-93811101.794100.492.32102.30100.992.32
291220-9122098.98299.48
396422-96422104.627105.15
490769-9076998.49398.98
591495-9149599.28199.77
691924-9192499.746100.24
30min193693-93693101.666100.312.48102.34100.982.48
291014-9101498.75999.42
396538-96538104.753105.45
490498-9049898.19998.85
591243-9124399.00799.67
691684-9168499.486100.15
45min193456-93456101.408100.002.45102.26100.842.46
290671-9067198.38699.21
396147-96147104.328105.20
490242-9024297.92198.74
590856-9085698.58799.41
691594-9159499.388100.22
极限193232-93232101.16599.732.38102.18100.732.38
290472-9047298.17199.16
395697-95697103.840104.89
489886-8988697.53598.52
590756-9075698.47999.47
691397-9139799.174100.17
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)0
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%
113.549922399097991549889298615989960.25
213.519917298829990000.25
单位质量响应值RSD%判断
7311.377327.910.16数据可信
长期6月-供试品溶液-2024022021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%
5min1101827-10182790.18191.862.5990.1891.862.59
2101821-10182190.17690.18
3108887-10888796.43496.43
4104194-10419492.27892.28
5103152-10315291.35591.35
6102476-10247690.75690.76
10min1109549-10954997.02098.462.9697.1798.612.96
2108556-10855696.14196.29
3117421-117421103.992104.15
4110546-11054697.90398.06
5111951-11195199.14899.30
6109032-10903296.56296.71
15min1109226-10922696.73499.393.1397.0599.713.13
2108243-10824395.86496.17
3117583-117583104.135104.47
4114786-114786101.658101.98
5112504-11250499.63799.95
6111022-11102298.32598.64
20min1109913-10991397.34399.462.6297.8299.942.63
2109048-10904896.57797.05
3117004-117004103.623104.13
4113749-113749100.740101.23
5113209-113209100.262100.75
6110901-11090198.21898.69
30min1109806-10980697.24899.142.9497.8899.792.94
2108590-10859096.17196.80
3117399-117399103.973104.65
4113934-113934100.904101.56
5112129-11212999.30599.96
6109813-10981397.25497.89
45min1109015-10901596.54798.912.8097.3499.722.80
2108275-10827595.89296.68
3116268-116268102.971103.82
4114073-114073101.027101.85
5112437-11243799.578100.39
6110020-11002097.43798.24
极限1109606-10960697.07196.813.0998.0397.783.08
2108507-10850796.09797.05
3114024-114024100.983102.01
4105395-10539593.34194.33
5112211-11221199.378100.36
6106095-10609593.96194.93
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