托伐普坦口崩片项目信息
介质体积(ml)
900
取样体积(ml)
5
补液体积(ml)
5
对照品批号
101242-201201
对照品来源
工作对照品
对照品使用方法
直接使用
对照品含量(%)
100.0
对照品水分(%)
0
对照品稀释倍数
10000
标示量(mg)
15
供试品稀释倍数
10
系数
1
对照品溶液
序号
称样量(mg)
A
1
A
2
A
3
A
4
A
5
A
平均
RSD%
1
16.12
194842
194890
194776
194505
194685
194740
0.08
2
16.17
193828
195061
194444
0.45
单位质量响应值
RSD%
判断
12080.65
12024.98
0.33
数据可信
供试品溶液-3G80SDA2批-SHUI(内含0.22%SDS)
时间
(分钟)
样品
A
1
A
2
A
平均
溶出量(%)
平均(%)
RSD%
累计溶
出量(%)
平均(%)
RSD%
5min
1
126392
-
126392
62.919
63.88
1.06
62.92
63.88
1.05
2
128445
-
128445
63.941
63.94
3
130613
-
130613
65.021
65.02
4
128194
-
128194
63.816
63.82
5
128057
-
128057
63.748
63.75
6
128210
-
128210
63.824
63.82
10min
1
166823
-
166823
83.046
83.79
1.41
83.40
84.15
1.41
2
167722
-
167722
83.494
83.85
3
169269
-
169269
84.264
84.63
4
166763
-
166763
83.017
83.37
5
166640
-
166640
82.955
83.31
6
172708
-
172708
85.976
86.33
15min
1
178029
-
178029
88.625
91.54
1.71
89.44
92.36
1.69
2
183776
-
183776
91.486
92.30
3
186039
-
186039
92.612
93.44
4
186214
-
186214
92.700
93.52
5
183328
-
183328
91.263
92.08
6
185938
-
185938
92.562
93.39
20min
1
181042
-
181042
90.125
94.24
2.51
91.43
95.57
2.49
2
194632
-
194632
96.890
98.22
3
187402
-
187402
93.291
94.63
4
191990
-
191990
95.575
96.91
5
189235
-
189235
94.203
95.53
6
191589
-
191589
95.375
96.72
30min
1
189040
-
189040
94.106
95.86
1.27
95.91
97.71
1.26
2
195806
-
195806
97.475
99.34
3
194458
-
194458
96.803
98.67
4
190867
-
190867
95.016
96.88
5
192709
-
192709
95.933
97.78
6
192449
-
192449
95.803
97.68
45min
1
185241
-
185241
92.215
94.50
1.32
94.54
96.88
1.31
2
192604
-
192604
95.881
98.29
3
190693
-
190693
94.929
97.33
4
189456
-
189456
94.313
96.70
5
191000
-
191000
95.082
97.46
6
189992
-
189992
94.580
96.99
60min
1
184542
-
184542
91.867
94.35
1.60
94.71
97.26
1.57
2
187873
-
187873
93.525
96.47
3
191209
-
191209
95.186
98.11
4
193159
-
193159
96.157
99.07
5
190911
-
190911
95.038
97.94
6
189539
-
189539
94.355
97.29
极限
1
187000
-
187000
93.091
94.97
1.44
96.44
98.41
1.42
2
194110
-
194110
96.630
100.09
3
189079
-
189079
94.126
97.58
4
191156
-
191156
95.160
98.61
5
193603
-
193603
96.378
99.81
6
189732
-
189732
94.451
97.91
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图1 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>溶剂 图2 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-1-1 图3 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-1-2 图4 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-1-3 图5 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-1-4 图6 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-1-5 图7 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-5min-片1<br>供试品溶液-1 图8 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-5min-片2<br>供试品溶液-1 图9 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-5min-片3<br>供试品溶液-1 图10 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-5min-片4<br>供试品溶液-1 图11 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-5min-片5<br>供试品溶液-1 图12 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-5min-片6<br>供试品溶液-1 图13 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-10min-片1<br>供试品溶液-1 图14 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-10min-片2<br>供试品溶液-1 图15 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-10min-片3<br>供试品溶液-1 图16 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-10min-片4<br>供试品溶液-1 图17 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-10min-片5<br>供试品溶液-1 图18 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-10min-片6<br>供试品溶液-1 图19 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-15min-片1<br>供试品溶液-1 图20 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-15min-片2<br>供试品溶液-1 图21 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-15min-片3<br>供试品溶液-1 图22 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-15min-片4<br>供试品溶液-1 图23 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-15min-片5<br>供试品溶液-1 图24 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-15min-片6<br>供试品溶液-1 图25 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-20min-片1<br>供试品溶液-1 图26 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-20min-片2<br>供试品溶液-1 图27 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-20min-片3<br>供试品溶液-1 图28 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-20min-片4<br>供试品溶液-1 图29 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-20min-片5<br>供试品溶液-1 图30 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-20min-片6<br>供试品溶液-1 图31 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-30min-片1<br>供试品溶液-1 图32 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-30min-片2<br>供试品溶液-1 图33 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-30min-片3<br>供试品溶液-1 图34 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-30min-片4<br>供试品溶液-1 图35 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-30min-片5<br>供试品溶液-1 图36 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-30min-片6<br>供试品溶液-1 图37 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-45min-片1<br>供试品溶液-1 图38 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-45min-片2<br>供试品溶液-1 图39 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-45min-片3<br>供试品溶液-1 图40 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-45min-片4<br>供试品溶液-1 图41 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-45min-片5<br>供试品溶液-1 图42 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-45min-片6<br>供试品溶液-1 图43 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-60min-片1<br>供试品溶液-1 图44 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-60min-片2<br>供试品溶液-1 图45 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-60min-片3<br>供试品溶液-1 图46 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-60min-片4<br>供试品溶液-1 图47 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-60min-片5<br>供试品溶液-1 图48 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-60min-片6<br>供试品溶液-1 图49 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-极限转速-片1<br>供试品溶液-1 图50 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-极限转速-片2<br>供试品溶液-1 图51 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-极限转速-片3<br>供试品溶液-1 图52 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-极限转速-片4<br>供试品溶液-1 图53 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-极限转速-片5<br>供试品溶液-1 图54 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质-极限转速-片6<br>供试品溶液-1 图55 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-2-1 图56 托伐普坦口崩片溶出曲线测定HPLC图谱<br>参比制剂-3G80SDA2批-SHUI(内含0.22%SDS)介质<br>对照品溶液-2-2
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