依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851287271286851285511286501285811286390.06
210.881300981297811299400.18
单位质量响应值RSD%判断
11856.1311943.010.52数据可信
供试品溶液-NB2A批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1125057-12505791.08691.131.7991.0991.131.79
2127308-12730892.72592.73
3127075-12707592.55692.56
4124369-12436990.58590.58
5121193-12119388.27288.27
6125672-12567291.53491.53
10min1126090-12609091.83892.841.3291.9993.001.32
2130041-13004194.71694.87
3128530-12853093.61593.77
4125655-12565591.52191.67
5126546-12654692.17092.32
6127952-12795293.19593.35
15min1125798-12579891.62692.361.1991.9392.671.19
2129216-12921694.11594.43
3127385-12738592.78293.09
4124971-12497191.02391.33
5126089-12608991.83892.14
6127383-12738392.78093.09
20min1124195-12419590.45892.001.5190.9292.461.51
2129384-12938494.23894.71
3127060-12706092.54593.01
4124529-12452990.70191.16
5125917-12591791.71292.17
6126780-12678092.34192.80
30min1123889-12388990.23591.641.4090.8492.261.40
2128527-12852793.61394.24
3126696-12669692.28092.90
4124022-12402290.33290.94
5125465-12546591.38391.99
6126339-12633992.02092.64
45min1123673-12367390.07891.341.2790.8492.101.27
2127609-12760992.94593.73
3126601-12660192.21192.98
4123728-12372890.11890.87
5124973-12497391.02591.78
6125852-12585291.66592.43
60min1124163-12416390.43591.261.3391.3492.181.33
2127954-12795493.19694.13
3126222-12622291.93492.86
4123298-12329889.80590.71
5124622-12462290.76991.68
6125504-12550491.41192.33
极限1123805-12380590.17490.991.2691.2392.061.26
2127569-12756992.91694.01
3125577-12557791.46592.54
4123159-12315989.70490.76
5124314-12431490.54591.61
6125106-12510691.12292.20
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851292781293711295401295551295871294660.11
210.881286301288451287380.12
单位质量响应值RSD%判断
11932.3511832.540.60数据可信
供试品溶液-NB2A批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1123544-12354490.11489.791.1390.1189.791.13
2124053-12405390.48590.49
3125030-12503091.19891.20
4122361-12236189.25189.25
5122484-12248489.34189.34
6121143-12114388.36388.36
10min1124766-12476691.00590.730.9391.1690.880.93
2124128-12412890.54090.69
3126284-12628492.11392.26
4124587-12458790.87591.02
5122860-12286089.61589.76
6123696-12369690.22590.37
15min1124419-12441990.75290.450.8991.0590.750.89
2123733-12373390.25290.55
3125768-12576891.73692.04
4124269-12426990.64390.94
5122577-12257789.40989.71
6123247-12324789.89790.20
20min1124252-12425290.63090.250.8691.0890.700.86
2123631-12363190.17790.63
3125404-12540491.47191.93
4123812-12381290.31090.76
5122394-12239489.27589.72
6122893-12289389.63990.09
30min1123368-12336889.98689.920.7390.5990.520.73
2123437-12343790.03690.64
3124890-12489091.09691.71
4123009-12300989.72490.33
5122301-12230189.20789.80
6122683-12268389.48690.08
45min1123275-12327589.91889.780.7990.6790.530.79
2122908-12290889.65090.40
3124617-12461790.89791.66
4123440-12344090.03890.79
5121779-12177988.82789.57
6122470-12247089.33190.08
60min1122951-12295189.68189.450.8290.5990.350.82
2122499-12249989.35290.25
3124366-12436690.71491.63
4122451-12245189.31790.22
5121387-12138788.54189.43
6122150-12215089.09789.99
极限1122967-12296789.69389.230.7190.7590.280.72
2122261-12226189.17890.23
3123583-12358390.14291.21
4122242-12224289.16490.21
5121073-12107388.31289.35
6121904-12190488.91889.96
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