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
197412
197434
197290
197041
196992
197234
0.11
2
11.52
196561
196852
196706
0.11
单位质量响应值
RSD%
判断
17240.73
17075.17
0.69
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
161743
161691
161717
84.62
86.47
2.36
84.33%～88.60%
2
160624
160626
160625
84.05
3
163625
163604
163614
85.61
4
166546
166448
166497
87.12
5
168810
168986
168898
88.37
6
170169
170178
170174
89.04
2024030221
1
178547
178615
178581
93.44
93.93
1.91
92.05%～95.81%
2
175417
175502
175460
91.81
3
177377
177196
177286
92.76
4
178992
178779
178886
93.60
5
181999
181832
181916
95.19
6
185121
184882
185002
96.80
2024030321
1
140983
141130
141056
73.81
78.71
7.41
72.59%～84.82%
2
152887
152776
152832
79.97
3
143522
143670
143596
75.14
4
148082
148300
148191
77.54
5
171539
171676
171608
89.79
6
145223
145227
145225
75.99
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
5000
标示量(mg)
10
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
161780
161496
161193
161090
161103
161332
0.19
2
11.48
161004
161019
161012
0.01
单位质量响应值
RSD%
判断
14077.84
14025.44
0.27
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
166156
166299
166228
97.71
90.04
5.41
84.93%～95.14%
2
143697
143967
143832
84.55
3
147750
147883
147816
86.89
4
151446
151332
151389
88.99
5
149577
150359
149968
88.16
6
159780
159724
159752
93.91
2024030221
1
171163
170832
170998
100.52
97.36
3.36
93.93%～100.79%
2
160498
160295
160396
94.29
3
161838
161703
161770
95.09
4
163041
162895
162968
95.80
5
163492
163494
163493
96.11
6
174311
173933
174122
102.35
2024030321
1
162751
162864
162808
95.70
90.52
7.40
83.50%～97.55%
2
149769
149668
149718
88.01
3
165967
166232
166100
97.64
4
149058
149021
149040
87.61
5
135797
135466
135632
79.73
6
160725
160630
160678
94.45
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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/10mg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/10mg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/10mg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/10mg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/10mg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/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011221批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011222批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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(2024011223批)(10mg/10mg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/10mg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/10mg规格)-pH6.8(内含0.2%Tween80)介质<br>对照品溶液-2-2
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