盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.871968511969071968901971201968611969260.06
210.941974791975681975240.04
单位质量响应值RSD%判断
18116.4718055.210.24数据可信
供试品溶液-T0704607DD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%
5min115689-156897.78714.2338.707.7914.2438.68
237290-3729018.50818.51
319278-192789.5689.57
421313-2131310.57810.58
541071-4107120.38520.38
637439-3743918.58218.58
10min167414-6741433.46048.3119.8633.4748.3419.88
2106936-10693653.07653.11
399187-9918749.23049.25
480945-8094540.17640.19
5114928-11492857.04357.08
6114633-11463356.89656.93
15min1123628-12362861.36175.8911.1961.4375.9911.21
2163427-16342781.11481.23
3155179-15517977.02177.12
4142048-14204870.50370.59
5166824-16682482.80182.93
6166259-16625982.52082.65
20min1167749-16774983.26088.323.2583.4388.553.29
2180977-18097789.82590.08
3178640-17864088.66588.89
4175032-17503286.87487.08
5183448-18344891.05291.32
6181776-18177690.22290.49
30min1190660-19066094.63195.940.8294.9496.320.85
2192804-19280495.69596.10
3193901-19390196.24096.61
4193471-19347196.02696.37
5195484-19548497.02597.44
6193461-19346196.02196.44
45min1198293-19829398.42098.750.5498.8999.290.53
2197592-19759298.07298.64
3199846-19984699.19099.73
4199917-19991799.22699.73
5199922-19992299.22899.81
6198164-19816498.35698.93
60min1199895-19989599.21599.200.7099.8599.900.69
2197795-19779598.17298.90
3200791-20079199.660100.36
4201228-20122899.876100.55
5200903-20090399.715100.46
6198587-19858798.56699.30
极限1200151-20015199.34299.200.59100.14100.070.57
2198084-19808498.31699.21
3200613-20061399.571100.44
4200968-20096899.747100.59
5200615-20061599.572100.48
6198729-19872998.63699.54
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.871976231975611972031971781969951973120.14
210.941988691987911988300.03
单位质量响应值RSD%判断
18151.9818174.590.09数据可信
供试品溶液-T0704607DD批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min147937-4793723.69123.738.6223.6923.738.62
254154-5415426.76426.76
347392-4739223.42223.42
442193-4219320.85220.85
550812-5081225.11225.11
645617-4561722.54522.54
10min198001-9800148.43453.829.8548.4753.869.85
2128021-12802163.27063.31
3101193-10119350.01150.05
4113266-11326655.97856.01
5105876-10587652.32652.37
6107068-10706852.91552.95
15min1150043-15004374.15475.902.0074.2776.032.01
2157484-15748477.83177.98
3149812-14981274.04074.16
4155138-15513876.67276.80
5155198-15519876.70176.83
6153813-15381376.01776.14
20min1163146-16314680.63082.221.4680.8782.481.47
2168433-16843383.24283.52
3163516-16351680.81281.06
4168320-16832083.18783.44
5168019-16801983.03883.29
6166786-16678682.42882.68
30min1176457-17645787.20888.160.8887.5988.560.88
2179945-17994588.93289.35
3176854-17685487.40487.78
4180218-18021889.06789.46
5178124-17812488.03288.43
6178728-17872888.33088.72
45min1184872-18487291.36792.550.9291.8993.090.92
2188320-18832093.07193.64
3186117-18611791.98292.51
4188011-18801192.91893.46
5189609-18960993.70894.25
6186652-18665292.24792.78
60min1188138-18813892.98194.441.2693.6695.141.26
2192302-19230295.03995.76
3190382-19038294.09094.77
4193754-19375495.75796.45
5193358-19335895.56196.26
6188650-18865093.23493.92
极限1192031-19203194.90595.520.8295.7496.370.83
2193511-19351195.63696.52
3192498-19249895.13695.97
4195634-19563496.68697.54
5194511-19451196.13196.99
6191486-19148694.63695.48
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