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%
110.078362783527835158356383626835720.07
210.068327983249832640.03
单位质量响应值RSD%判断
8299.118276.740.20数据可信
长期3月-供试品溶液-2024021621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%
5min190218-9021897.77495.943.1397.7795.943.13
288419-8841995.82495.82
392560-92560100.312100.31
488671-8867196.09796.10
586784-8678494.05294.05
684519-8451991.59791.60
10min193117-93117100.915100.101.29101.08100.261.29
292713-92713100.477100.64
393351-93351101.169101.34
490325-9032597.88998.05
591575-9157599.24499.40
693106-93106100.903101.06
15min192925-92925100.707100.211.44101.04100.541.43
292934-92934100.717101.04
393612-93612101.452101.79
490227-9022797.78398.11
591549-9154999.21699.54
693539-93539101.373101.69
20min193087-93087100.883100.221.31101.38100.711.31
292752-92752100.520101.01
393276-93276101.088101.59
490204-9020497.75898.24
592121-9212199.836100.32
693414-93414101.237101.73
30min192550-92550100.30199.841.43100.97100.501.43
292709-92709100.473101.14
392979-92979100.766101.44
489752-8975297.26997.92
591473-9147399.13499.79
693291-93291101.104101.76
45min192255-9225599.98199.571.51100.82100.401.50
292334-92334100.067100.90
392888-92888100.667101.51
490787-9078798.39099.20
589659-8965997.16897.99
693312-93312101.127101.95
极限191933-9193399.63299.291.27100.63100.281.27
292019-9201999.725100.72
392499-92499100.246101.25
489457-8945796.94997.92
591259-9125998.90299.88
692544-92544100.294101.29
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)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%
113.851021101022251020951021271019361020990.11
213.971017911018331018120.03
单位质量响应值RSD%判断
7371.777287.900.81数据可信
长期3月-供试品溶液-2024021621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%
5min1103743-10374391.75390.344.6791.7590.344.67
298965-9896587.52887.53
3109063-10906396.45996.46
4104894-10489492.77192.77
5100619-10061988.99088.99
695585-9558584.53884.54
10min1108545-10854596.00095.802.1296.1595.952.13
2105934-10593493.69193.84
3111532-11153298.64298.80
4110010-11001097.29697.45
5108322-10832295.80395.95
6105597-10559793.39393.53
15min1109211-10921196.58996.541.9696.9096.851.96
2106583-10658394.26594.57
3112561-11256199.55299.88
4110440-11044097.67697.99
5108529-10852995.98696.29
6107585-10758595.15195.45
20min1109553-10955396.89296.621.8797.3797.091.88
2106628-10662894.30594.76
3112344-11234499.36099.85
4110553-11055397.77698.26
5108610-10861096.05896.53
6107772-10777295.31795.77
30min1109083-10908396.47696.871.2497.1197.501.25
2107587-10758795.15395.77
3111546-11154698.65599.31
4110337-11033797.58598.23
5109740-10974097.05797.69
6108846-10884696.26796.88
45min1108370-10837095.84696.901.6496.6497.691.64
2106852-10685294.50395.28
3112060-11206099.10999.93
4109624-10962496.95597.76
5110485-11048597.71698.51
6109948-10994897.24198.02
极限1108896-10889696.31196.781.5697.2797.741.56
2106915-10691594.55995.49
3112044-11204499.095100.08
4110371-11037197.61598.58
5109340-10934096.70497.66
6109018-10901896.41997.36
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%
110.078341883461833628345083403834190.05
210.068351383630835720.10
单位质量响应值RSD%判断
8283.918307.360.20数据可信
长期3月-供试品溶液-2024021821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%
5min192274-9227499.90999.880.7599.9199.880.75
292034-9203499.64999.65
391664-9166499.24899.25
491928-9192899.53499.53
592004-9200499.61699.62
693591-93591101.335101.33
10min192971-92971100.663100.600.74100.83100.770.74
292823-92823100.503100.67
392254-9225499.887100.05
492395-92395100.040100.21
592875-92875100.560100.73
694184-94184101.977102.15
15min192775-92775100.451100.570.85100.79100.910.85
292864-92864100.548100.88
392196-9219699.824100.16
492385-92385100.029100.36
592693-92693100.362100.70
694396-94396102.206102.55
20min192774-92774100.450100.280.72100.95100.790.72
292632-92632100.296100.80
391886-9188699.48999.99
492157-9215799.782100.28
592486-92486100.138100.64
693790-93790101.550102.06
30min192589-92589100.250100.110.94100.92100.780.94
292347-9234799.988100.66
391467-9146799.03599.70
492124-9212499.746100.41
592191-9219199.819100.49
694053-94053101.835102.51
45min192368-92368100.01199.890.82100.85100.730.83
292249-9224999.882100.72
391371-9137198.93199.76
491826-9182699.424100.26
592131-9213199.754100.59
693621-93621101.367102.22
极限192163-9216399.78999.690.97100.79100.690.97
291800-9180099.396100.40
391214-9121498.76199.76
491475-9147599.044100.04
592030-9203099.645100.65
693743-93743101.499102.52
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%
113.851019291018921020841018841020081019590.09
213.971019761020081019920.03
单位质量响应值RSD%判断
7361.667300.790.59数据可信
长期3月-供试品溶液-2024021821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%
5min1107409-10740994.97699.642.9394.9899.642.93
2117441-117441103.847103.85
3112162-11216299.17999.18
4113396-113396100.270100.27
5111627-11162798.70698.71
6114034-114034100.834100.83
10min1110285-11028597.519102.192.7497.68102.352.74
2120034-120034106.140106.31
3115727-115727102.331102.50
4114775-114775101.490101.66
5115756-115756102.357102.52
6116797-116797103.278103.45
15min1109165-10916596.529101.412.8196.85101.752.81
2119211-119211105.412105.76
3114855-114855101.560101.90
4114340-114340101.105101.44
5115042-115042101.726102.06
6115501-115501102.132102.47
20min1108919-10891996.311101.052.8296.79101.552.82
2118947-118947105.179105.70
3114209-114209100.989101.49
4113719-113719100.556101.06
5114719-114719101.440101.94
6115145-115145101.817102.33
30min1108910-10891096.303100.882.5596.95101.552.55
2117797-117797104.162104.86
3114285-114285101.056101.73
4114106-114106100.898101.57
5114027-114027100.828101.50
6115371-115371102.017102.70
45min1108691-10869196.110100.882.8496.91101.722.84
2118765-118765105.018105.89
3113850-113850100.672101.51
4113913-113913100.727101.57
5114119-114119100.910101.75
6115165-115165101.834102.68
极限1108089-10808995.578100.472.8796.54101.472.87
2118106-118106104.435105.48
3113571-113571100.425101.43
4112946-11294699.872100.88
5114074-114074100.870101.88
6114912-114912101.611102.63
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%
110.078315083166831188325583087831550.08
210.068344683436834410.01
单位质量响应值RSD%判断
8257.708294.330.32数据可信
长期3月-供试品溶液-2024022021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%
5min189491-8949197.125100.672.2997.13100.672.29
290761-9076198.50498.50
393871-93871101.879101.88
493995-93995102.014102.01
594854-94854102.946102.95
693555-93555101.536101.54
10min190136-9013697.826101.262.2797.99101.432.26
291165-9116598.94299.11
394309-94309102.355102.52
494621-94621102.693102.86
595272-95272103.400103.57
694318-94318102.364102.53
15min189798-8979897.459101.072.3497.78101.402.34
290947-9094798.70699.03
394369-94369102.420102.76
494640-94640102.714103.05
594825-94825102.915103.26
694168-94168102.201102.54
20min189704-8970497.357101.012.3597.84101.512.35
290959-9095998.71999.21
394143-94143102.174102.69
494605-94605102.676103.19
594952-94952103.052103.57
694042-94042102.065102.57
30min189468-8946897.101100.722.3797.75101.402.37
290572-9057298.29998.96
394072-94072102.097102.78
494060-94060102.084102.77
594626-94626102.699103.39
694041-94041102.064102.74
45min189219-8921996.830100.432.3097.64101.272.30
290585-9058598.31399.13
393979-93979101.996102.85
493736-93736101.733102.59
594451-94451102.509103.37
693256-93256101.212102.06
极限189314-8931496.933100.202.1697.91101.202.16
290358-9035898.06699.05
393633-93633101.621102.64
493248-93248101.203102.23
594202-94202102.238103.27
693164-93164101.112102.13
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%
113.851013821017041016531016591016091016010.13
213.971018561018221018390.03
单位质量响应值RSD%判断
7335.817289.840.45数据可信
长期3月-供试品溶液-2024022021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%
5min1106383-10638394.30596.531.7694.3096.521.77
2109898-10989897.42197.42
3107271-10727195.09295.09
4110374-11037497.84397.84
5111269-11126998.63698.64
6108135-10813595.85895.86
10min1109599-10959997.15698.171.2297.3198.331.22
2110851-11085198.26698.43
3109744-10974497.28497.44
4112081-11208199.35699.52
5112618-11261899.832100.00
6109574-10957497.13497.29
15min1109291-10929196.88398.051.2797.2098.371.28
2110530-11053097.98198.31
3109586-10958697.14497.46
4112118-11211899.38999.72
5112535-11253599.759100.09
6109572-10957297.13297.45
20min1108996-10899696.62198.041.5997.1098.521.59
2110421-11042197.88598.37
3109179-10917996.78497.27
4112246-11224699.502100.00
5113213-113213100.360100.86
6109498-10949897.06697.55
30min1108592-10859296.26397.531.2996.9098.181.29
2109814-10981497.34698.00
3109235-10923596.83397.48
4110910-11091098.31898.98
5112428-11242899.664100.33
6109153-10915396.76197.41
45min1108105-10810595.83197.291.5496.6398.111.55
2109899-10989997.42298.24
3108988-10898896.61497.42
4110577-11057798.02398.85
5112622-11262299.836100.67
6108323-10832396.02596.83
极限1108712-10871296.37097.071.3497.3398.041.34
2109674-10967497.22298.20
3108537-10853796.21497.18
4110289-11028997.76898.75
5111908-11190899.203100.20
6107870-10787095.62396.59
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