依折麦布辛伐他汀片项目信息
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对照品来源工作对照品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)A1A2A3A4A5A平均RSD%
111.10190766
190766+0		191037
191037+0		191023
191023+0		190814
190814+0		190917
190917+0		1909110.07
211.06190700
190700+0		190734
190734+0		1907170.02
单位质量响应值RSD%判断
17199.1917243.850.19数据可信
供试品溶液-Y012651批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15964
5964+0		-59643.1093.154.373.113.154.32
26205
6205+0		-62053.2353.23
36483
6483+0		-64833.3803.38
45876
5876+0		-58763.0633.06
55976
5976+0		-59763.1153.12
65746
5746+0		-57462.9953.00
10min19388
9388+0		-93884.8944.753.424.914.773.40
28818
8818+0		-88184.5974.61
39386
9386+0		-93864.8934.91
49057
9057+0		-90574.7214.74
58686
8686+0		-86864.5284.55
69359
9359+0		-93594.8794.90
15min110883
10883+0		-108835.6735.9310.435.725.9710.36
211081
11081+0		-110815.7765.82
310964
10964+0		-109645.7155.76
411012
11012+0		-110125.7415.78
510541
10541+0		-105415.4955.54
613761
13761+0		-137617.1747.22
20min111799
11799+0		-117996.1516.413.516.236.493.50
212411
12411+0		-124116.4706.55
312447
12447+0		-124476.4896.57
411732
11732+0		-117326.1166.19
512594
12594+0		-125946.5656.64
612783
12783+0		-127836.6646.75
30min112709
12709+0		-127096.6256.751.936.746.861.86
213315
13315+0		-133156.9417.05
312699
12699+0		-126996.6206.73
412998
12998+0		-129986.7766.88
513147
13147+0		-131476.8536.96
612822
12822+0		-128226.6846.80
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min113766
13766+0		-137667.1767.113.527.327.263.40
214279
14279+0		-142797.4447.59
313895
13895+0		-138957.2437.39
413788
13788+0		-137887.1887.33
513129
13129+0		-131296.8446.99
613027
13027+0		-130276.7916.95
60min114435
14435+0		-144357.5257.441.957.717.641.95
214383
14383+0		-143837.4987.69
314172
14172+0		-141727.3887.58
414595
14595+0		-145957.6087.80
513791
13791+0		-137917.1897.37
614315
14315+0		-143157.4627.66
极限113839
13839+0		-138397.2147.292.207.447.522.13
214450
14450+0		-144507.5337.77
313793
13793+0		-137937.1907.42
414261
14261+0		-142617.4347.66
513876
13876+0		-138767.2347.46
613655
13655+0		-136557.1187.36
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.99429966
429815
429726
430004
429974
4298970.03
210.99432949
432287
4326180.11
单位质量响应值RSD%判断
39117.1139364.700.45数据可信
供试品溶液-Y012651批-辛伐他汀-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11768
-17680.4030.3610.120.400.369.74
21469
-14690.3350.34
31607
-16070.3670.37
41567
-15670.3580.36
51312
-13120.2990.30
61656
-16560.3780.38
10min12795
-27950.6380.5713.180.640.5813.15
22280
-22800.5200.52
32605
-26050.5940.60
42039
-20390.4650.47
52414
-24140.5510.55
62921
-29210.6670.67
15min12738
-27380.6250.737.500.630.737.46
23305
-33050.7540.76
33437
-34370.7840.79
43284
-32840.7490.75
53175
-31750.7250.73
63189
-31890.7280.73
20min13840
-38400.8760.903.890.890.913.68
23897
-38970.8890.90
34090
-40900.9330.94
44106
-41060.9370.95
53709
-37090.8460.86
63968
-39680.9060.92
30min14660
-46601.0631.086.081.081.106.01
25195
-51951.1861.20
34466
-44661.0191.03
44520
-45201.0321.05
55004
-50041.1421.16
64649
-46491.0611.08
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min15562
-55621.2691.255.081.291.274.89
25927
-59271.3531.37
35626
-56261.2841.30
45432
-54321.2401.26
55291
-52911.2071.23
65133
-51331.1711.19
60min16430
-64301.4671.407.481.491.437.46
26108
-61081.3941.42
36238
-62381.4241.45
45251
-52511.1981.22
56450
-64501.4721.50
66409
-64091.4631.49
极限16673
-66731.5231.537.711.561.577.52
27212
-72121.6461.68
35813
-58131.3271.36
47194
-71941.6421.67
56561
-65611.4971.53
66884
-68841.5711.61
依折麦布辛伐他汀片项目信息
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对照品来源工作对照品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)A1A2A3A4A5A平均RSD%
111.10190158
190158+0		190399
190399+0		190324
190324+0		190188
190188+0		190429
190429+0		1903000.07
211.06189585
189585+0		189482
189482+0		1895340.04
单位质量响应值RSD%判断
17144.1417136.890.03数据可信
供试品溶液-Y012651批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16005
6005+0		-60053.1453.137.413.153.137.46
26350
6350+0		-63503.3263.33
36547
6547+0		-65473.4293.43
45307
5307+0		-53072.7802.78
55717
5717+0		-57172.9942.99
65951
5951+0		-59513.1173.12
10min19339
9339+0		-93394.8914.824.204.914.844.19
29633
9633+0		-96335.0455.06
39558
9558+0		-95585.0065.03
48709
8709+0		-87094.5614.58
58786
8786+0		-87864.6024.62
69243
9243+0		-92434.8414.86
15min111381
11381+0		-113815.9615.683.326.015.723.33
210886
10886+0		-108865.7025.75
311050
11050+0		-110505.7885.83
410464
10464+0		-104645.4815.52
510434
10434+0		-104345.4655.51
610819
10819+0		-108195.6675.71
20min112146
12146+0		-121466.3626.183.026.446.263.01
211975
11975+0		-119756.2726.35
312008
12008+0		-120086.2896.37
411258
11258+0		-112585.8965.97
511465
11465+0		-114656.0056.08
611980
11980+0		-119806.2756.35
30min112586
12586+0		-125866.5926.684.536.716.804.40
212036
12036+0		-120366.3046.42
312297
12297+0		-122976.4416.55
413323
13323+0		-133236.9787.08
513521
13521+0		-135217.0827.19
612814
12814+0		-128146.7116.82
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min113104
13104+0		-131046.8636.861.527.017.011.48
213410
13410+0		-134107.0247.17
313184
13184+0		-131846.9057.05
412963
12963+0		-129636.7896.93
512831
12831+0		-128316.7206.87
613128
13128+0		-131286.8767.02
60min112883
12883+0		-128836.7487.013.356.947.203.20
213497
13497+0		-134977.0697.26
313755
13755+0		-137557.2047.39
414041
14041+0		-140417.3547.53
513125
13125+0		-131256.8747.06
613058
13058+0		-130586.8397.03
极限113480
13480+0		-134807.0607.213.377.297.443.26
213339
13339+0		-133396.9867.21
314188
14188+0		-141887.4317.66
414491
14491+0		-144917.5907.81
513474
13474+0		-134747.0577.28
613626
13626+0		-136267.1377.36
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.99430207
430767
431120
430782
430557
4306870.08
210.99428482
428715
4285980.04
单位质量响应值RSD%判断
39188.9938998.910.35数据可信
供试品溶液-Y012651批-辛伐他汀-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12571
-25710.5890.5518.510.590.5518.82
22376
-23760.5440.54
33056
-30560.7000.70
41717
-17170.3930.39
52201
-22010.5040.50
62586
-25860.5920.59
10min13764
-37640.8620.885.510.870.895.47
24019
-40190.9210.92
33895
-38950.8920.90
43528
-35280.8080.81
53786
-37860.8670.87
64129
-41290.9460.95
15min15065
-50651.1601.098.761.171.108.76
24290
-42900.9830.99
34872
-48721.1161.12
44308
-43080.9870.99
54753
-47531.0891.10
65346
-53461.2251.23
20min15655
-56551.2951.256.001.311.266.00
25702
-57021.3061.32
35483
-54831.2561.27
44871
-48711.1161.13
55303
-53031.2151.23
65725
-57251.3111.33
30min15606
-56061.2841.419.821.311.439.63
25608
-56081.2851.31
35845
-58451.3391.36
46545
-65451.4991.52
56093
-60931.3961.42
67137
-71371.6351.66
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min16761
-67611.5491.595.351.581.625.23
27379
-73791.6901.72
36818
-68181.5621.59
46378
-63781.4611.49
56963
-69631.5951.62
67304
-73041.6731.70
60min17042
-70421.6131.764.921.651.804.92
27437
-74371.7041.74
37850
-78501.7981.84
48122
-81221.8601.90
57767
-77671.7791.82
67804
-78041.7881.83
极限18373
-83731.9181.998.391.962.048.23
27901
-79011.8101.86
39685
-96852.2182.27
49350
-93502.1422.19
57987
-79871.8301.88
68814
-88142.0192.07
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