依折麦布阿托伐他汀钙片项目信息
介质体积(ml)
900
取样体积(ml)
5
补液体积(ml)
5
对照品批号
DSMF-387-240606
对照品来源
自制
对照品使用方法
直接使用
对照品含量(%)
99.75
对照品水分(%)
0
对照品稀释倍数
5000
标示量(mg)
10
供试品稀释倍数
5
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
11.44
196857
196621
196784
196947
196954
196833
0.07
2
11.52
198207
198747
198477
0.20
单位质量响应值
RSD%
判断
17205.68
17228.91
0.10
数据可信
供试品溶液-依折麦布-pH6.8(内含0.2%Tween80)
批号
样品(片)
A
1
A
2
A
平均
溶出量(%)
平均(%)
RSD%
置信区间
2024030121
1
136490
136781
136636
71.25
78.49
6.65
73.02%～83.97%
2
162464
162556
162510
84.74
3
146244
146261
146252
76.26
4
146897
146940
146918
76.61
5
161900
161995
161948
84.44
6
148891
148967
148929
77.66
2024030221
1
166301
167108
166704
86.92
90.18
2.95
87.39%～92.97%
2
171757
171518
171638
89.50
3
171325
171380
171352
89.35
4
169677
169786
169732
88.50
5
178955
178841
178898
93.28
6
179392
179337
179364
93.52
2024030321
1
151865
151847
151856
79.18
80.12
5.73
75.30%～84.94%
2
162969
162972
162970
84.98
3
166195
166143
166169
86.64
4
147233
147245
147239
76.77
5
148811
148783
148797
77.59
6
144878
144967
144922
75.57
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)
900
取样体积(ml)
5
补液体积(ml)
5
对照品批号
100590-202005
对照品来源
中检院
对照品使用方法
直接使用
对照品含量(%)
94.9
对照品水分(%)
0
对照品稀释倍数
2500
标示量(mg)
20
供试品稀释倍数
5
系数
0.9671
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
11.46
323806
323477
323780
323674
323840
323715
0.05
2
11.48
326560
327120
326840
0.13
单位质量响应值
RSD%
判断
28247.38
28470.38
0.56
数据可信
供试品溶液-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
批号
样品(片)
A
1
A
2
A
平均
溶出量(%)
平均(%)
RSD%
置信区间
2024030121
1
321289
321508
321398
93.61
93.79
6.83
87.07%～100.51%
2
363182
363323
363252
105.80
3
318195
318353
318274
92.70
4
309541
309631
309586
90.17
5
298732
298589
298660
86.99
6
320749
320927
320838
93.45
2024030221
1
334587
335432
335010
97.58
97.02
2.59
94.39%～99.65%
2
336898
336716
336807
98.10
3
326101
325925
326013
94.96
4
327043
327267
327155
95.29
5
325808
325816
325812
94.90
6
347780
347687
347734
101.28
2024030321
1
313071
312752
312912
91.14
94.26
4.04
90.26%～98.26%
2
346753
346834
346794
101.01
3
313342
313327
313334
91.27
4
329451
329508
329480
95.97
5
315748
315668
315708
91.96
6
323493
323426
323460
94.21
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图1 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>溶剂 图2 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-1-1 图3 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-1-2 图4 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-1-3 图5 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-1-4 图6 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-1-5 图7 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片1<br>供试品溶液-1 图8 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片1<br>供试品溶液-2 图9 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片2<br>供试品溶液-1 图10 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片2<br>供试品溶液-2 图11 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片3<br>供试品溶液-1 图12 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片3<br>供试品溶液-2 图13 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片4<br>供试品溶液-1 图14 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片4<br>供试品溶液-2 图15 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片5<br>供试品溶液-1 图16 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片5<br>供试品溶液-2 图17 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片6<br>供试品溶液-1 图18 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片6<br>供试品溶液-2 图19 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片1<br>供试品溶液-1 图20 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片1<br>供试品溶液-2 图21 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片2<br>供试品溶液-1 图22 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片2<br>供试品溶液-2 图23 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片3<br>供试品溶液-1 图24 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片3<br>供试品溶液-2 图25 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片4<br>供试品溶液-1 图26 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片4<br>供试品溶液-2 图27 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片5<br>供试品溶液-1 图28 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片5<br>供试品溶液-2 图29 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片6<br>供试品溶液-1 图30 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011621批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片6<br>供试品溶液-2 图31 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片1<br>供试品溶液-1 图32 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片1<br>供试品溶液-2 图33 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片2<br>供试品溶液-1 图34 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片2<br>供试品溶液-2 图35 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片3<br>供试品溶液-1 图36 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片3<br>供试品溶液-2 图37 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片4<br>供试品溶液-1 图38 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片4<br>供试品溶液-2 图39 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片5<br>供试品溶液-1 图40 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片5<br>供试品溶液-2 图41 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片6<br>供试品溶液-1 图42 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片6<br>供试品溶液-2 图43 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片1<br>供试品溶液-1 图44 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片1<br>供试品溶液-2 图45 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片2<br>供试品溶液-1 图46 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片2<br>供试品溶液-2 图47 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片3<br>供试品溶液-1 图48 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片3<br>供试品溶液-2 图49 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片4<br>供试品溶液-1 图50 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片4<br>供试品溶液-2 图51 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片5<br>供试品溶液-1 图52 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片5<br>供试品溶液-2 图53 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片6<br>供试品溶液-1 图54 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024011821批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片6<br>供试品溶液-2 图55 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片1<br>供试品溶液-1 图56 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片1<br>供试品溶液-2 图57 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片2<br>供试品溶液-1 图58 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片2<br>供试品溶液-2 图59 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片3<br>供试品溶液-1 图60 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片3<br>供试品溶液-2 图61 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片4<br>供试品溶液-1 图62 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片4<br>供试品溶液-2 图63 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片5<br>供试品溶液-1 图64 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片5<br>供试品溶液-2 图65 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片6<br>供试品溶液-1 图66 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-15min-片6<br>供试品溶液-2 图67 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片1<br>供试品溶液-1 图68 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片1<br>供试品溶液-2 图69 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片2<br>供试品溶液-1 图70 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片2<br>供试品溶液-2 图71 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片3<br>供试品溶液-1 图72 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片3<br>供试品溶液-2 图73 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片4<br>供试品溶液-1 图74 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片4<br>供试品溶液-2 图75 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片5<br>供试品溶液-1 图76 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片5<br>供试品溶液-2 图77 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片6<br>供试品溶液-1 图78 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(2024012021批)(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质-20min-片6<br>供试品溶液-2 图79 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-2-1 图80 依折麦布阿托伐他汀钙片溶出度测定HPLC图谱<br>自制品(10mg/20mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-2-2
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