盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.307921627921167919127919487912997918870.05
212.257839527846337842920.07
单位质量响应值RSD%判断
64381.0664023.840.40数据可信
供试品溶液-2024062221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1803585-80358594.87291.744.5594.8791.744.55
2795666-79566693.93793.94
3774970-77497091.49491.49
4786517-78651792.85792.86
5794044-79404493.74693.75
6707779-70777983.56183.56
10min1823333-82333397.20395.352.7297.3695.502.72
2821318-82131896.96697.12
3803297-80329794.83894.99
4815575-81557596.28796.44
5816820-81682096.43496.59
6765253-76525390.34690.49
15min1830481-83048198.04796.372.2798.3796.682.28
2823512-82351297.22597.54
3813385-81338596.02996.34
4825847-82584797.50097.82
5824044-82404497.28797.60
6780308-78030892.12492.41
20min1830647-83064798.06796.782.1198.5597.252.12
2827897-82789797.74298.22
3818821-81882196.67197.14
4829114-82911497.88698.36
5826379-82637997.56398.04
6785497-78549792.73693.18
30min1833946-83394698.45697.451.5899.1098.091.59
2829787-82978797.96598.61
3828147-82814797.77298.40
4831480-83148098.16598.81
5830158-83015898.00998.65
6799186-79918694.35394.95
45min1832329-83232998.26597.611.1099.0898.401.11
2828796-82879697.84898.65
3827215-82721597.66298.46
4829871-82987197.97598.78
5833514-83351498.40599.21
6808901-80890195.50096.25
60min1833726-83372698.43097.611.1399.4198.571.14
2827145-82714597.65398.62
3828216-82821697.78098.74
4829274-82927497.90598.87
5833723-83372398.43099.40
6808628-80862895.46796.38
极限1831137-83113798.12597.760.4199.2698.880.42
2825773-82577397.49198.62
3829299-82929997.90899.03
4825730-82573097.48698.62
5832154-83215498.24599.38
6824001-82400197.28298.36
盐酸伐地那非片项目信息
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.307862547886467886267879667880817879150.13
212.257829117815047822080.13
单位质量响应值RSD%判断
64058.1363853.710.23数据可信
供试品溶液-2024062221批-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%
5min1760812-76081290.16889.982.6590.1789.982.64
2785059-78505993.04293.04
3736908-73690887.33587.33
4780608-78060892.51492.51
5749601-74960188.83988.84
6742160-74216087.95787.96
10min1783484-78348492.85594.421.0593.0194.581.05
2809361-80936195.92296.08
3796215-79621594.36494.51
4799493-79949394.75294.91
5796478-79647894.39594.54
6795281-79528194.25394.40
15min1800813-80081394.90995.760.6095.2196.060.60
2807728-80772895.72896.04
3812257-81225796.26596.57
4810179-81017996.01996.33
5803795-80379595.26295.57
6812949-81294996.34796.65
20min1807629-80762995.71696.221.2596.1896.691.24
2805457-80545795.45995.93
3827314-82731498.04998.51
4819428-81942897.11597.59
5799471-79947194.75095.21
6812120-81212096.24996.71
30min1812698-81269896.31797.001.3496.9497.631.34
2809423-80942395.92996.56
3834414-83441498.89199.52
4827033-82703398.01698.65
5806205-80620595.54896.17
6821219-82121997.32797.95
45min1815839-81583996.68997.371.3697.4798.151.35
2815013-81501396.59297.38
3841000-84100099.671100.46
4827015-82701598.01498.81
5809809-80980995.97596.76
6820636-82063697.25898.04
60min1816499-81649996.76897.191.3697.7198.141.35
2814783-81478396.56497.52
3841607-84160799.743100.70
4818793-81879397.04098.00
5809402-80940295.92796.87
6819326-81932697.10398.05
极限1800312-80031294.84996.461.4395.9597.571.42
2815605-81560596.66297.78
3829281-82928198.28399.41
4819669-81966997.14398.27
5800062-80006294.82095.92
6818368-81836896.98998.10
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