坎地沙坦酯片项目信息
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
100685-201903
对照品来源
中检所
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)
8
供试品稀释倍数
1
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
15.94
38206
38475
38380
38443
38439
38389
0.29
2
15.97
39381
39092
39236
0.53
单位质量响应值
RSD%
判断
2408.34
2456.86
1.42
数据可信
供试品溶液-2025030422批-pH6.8(内含0.1%Tween80)
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
5617
-
5617
12.964
12.44
51.94
12.96
12.44
51.94
2
7284
-
7284
16.811
16.81
3
6947
-
6947
16.033
16.03
4
7385
-
7385
17.044
17.04
5
-
0.000
0.00
6
5105
-
5105
11.782
11.78
10min
1
15122
-
15122
34.901
40.01
16.32
34.92
40.03
16.33
2
20628
-
20628
47.608
47.64
3
18964
-
18964
43.768
43.79
4
19987
-
19987
46.129
46.16
5
14380
-
14380
33.188
33.19
6
14925
-
14925
34.446
34.47
15min
1
25055
-
25055
57.826
62.33
9.44
57.91
62.42
9.46
2
29774
-
29774
68.717
68.82
3
28460
-
28460
65.684
65.78
4
29550
-
29550
68.200
68.31
5
23946
-
23946
55.266
55.32
6
25252
-
25252
58.280
58.36
20min
1
32655
-
32655
75.366
77.73
4.20
75.54
77.92
4.22
2
35352
-
35352
81.590
81.81
3
34437
-
34437
79.479
79.69
4
35012
-
35012
80.806
81.02
5
32340
-
32340
74.639
74.79
6
32269
-
32269
74.475
74.65
30min
1
39818
-
39818
91.898
92.04
1.05
92.20
92.36
1.03
2
39874
-
39874
92.027
92.38
3
39460
-
39460
91.072
91.41
4
40172
-
40172
92.715
93.07
5
40515
-
40515
93.506
93.78
6
39442
-
39442
91.030
91.33
45min
1
42322
-
42322
97.677
98.12
1.75
98.13
98.60
1.73
2
42674
-
42674
98.489
99.00
3
42812
-
42812
98.808
99.30
4
41333
-
41333
95.394
95.90
5
42351
-
42351
97.744
98.17
6
43601
-
43601
100.629
101.08
60min
1
42016
-
42016
96.971
98.11
1.13
97.59
98.74
1.12
2
42330
-
42330
97.695
98.37
3
42823
-
42823
98.833
99.49
4
42507
-
42507
98.104
98.77
5
43286
-
43286
99.902
100.49
6
42090
-
42090
97.141
97.76
极限
1
43225
-
43225
99.761
99.57
1.50
100.54
100.38
1.48
2
43593
-
43593
100.610
101.45
3
42253
-
42253
97.518
98.34
4
42819
-
42819
98.824
99.65
5
44095
-
44095
101.769
102.53
6
42876
-
42876
98.955
99.74
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图1 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>溶剂 图2 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-1-1 图3 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-1-2 图4 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-1-3 图5 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-1-4 图6 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-1-5 图7 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-5min-片1<br>供试品溶液-1 图8 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-5min-片2<br>供试品溶液-1 图9 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-5min-片3<br>供试品溶液-1 图10 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-5min-片4<br>供试品溶液-1 图11 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-5min-片5<br>供试品溶液-1 图12 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-5min-片6<br>供试品溶液-1 图13 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-10min-片1<br>供试品溶液-1 图14 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-10min-片2<br>供试品溶液-1 图15 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-10min-片3<br>供试品溶液-1 图16 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-10min-片4<br>供试品溶液-1 图17 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-10min-片5<br>供试品溶液-1 图18 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-10min-片6<br>供试品溶液-1 图19 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-15min-片1<br>供试品溶液-1 图20 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-15min-片2<br>供试品溶液-1 图21 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-15min-片3<br>供试品溶液-1 图22 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-15min-片4<br>供试品溶液-1 图23 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-15min-片5<br>供试品溶液-1 图24 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-15min-片6<br>供试品溶液-1 图25 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-20min-片1<br>供试品溶液-1 图26 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-20min-片2<br>供试品溶液-1 图27 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-20min-片3<br>供试品溶液-1 图28 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-20min-片4<br>供试品溶液-1 图29 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-20min-片5<br>供试品溶液-1 图30 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-20min-片6<br>供试品溶液-1 图31 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-30min-片1<br>供试品溶液-1 图32 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-30min-片2<br>供试品溶液-1 图33 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-30min-片3<br>供试品溶液-1 图34 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-30min-片4<br>供试品溶液-1 图35 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-30min-片5<br>供试品溶液-1 图36 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-30min-片6<br>供试品溶液-1 图37 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-45min-片1<br>供试品溶液-1 图38 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-45min-片2<br>供试品溶液-1 图39 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-45min-片3<br>供试品溶液-1 图40 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-45min-片4<br>供试品溶液-1 图41 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-45min-片5<br>供试品溶液-1 图42 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-45min-片6<br>供试品溶液-1 图43 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-60min-片1<br>供试品溶液-1 图44 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-60min-片2<br>供试品溶液-1 图45 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-60min-片3<br>供试品溶液-1 图46 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-60min-片4<br>供试品溶液-1 图47 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-60min-片5<br>供试品溶液-1 图48 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-60min-片6<br>供试品溶液-1 图49 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-极限转速-片1<br>供试品溶液-1 图50 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-极限转速-片2<br>供试品溶液-1 图51 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-极限转速-片3<br>供试品溶液-1 图52 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-极限转速-片4<br>供试品溶液-1 图53 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-极限转速-片5<br>供试品溶液-1 图54 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质-极限转速-片6<br>供试品溶液-1 图55 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-2-1 图56 坎地沙坦酯片溶出曲线测定HPLC图谱<br>自制品-2025030422批(4mg规格)-pH6.8(内含0.1%Tween80)介质<br>对照品溶液-2-2
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