依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.5998908
98871
98929
98987
98865
989120.06
211.5699255
99142
991980.09
单位质量响应值RSD%判断
8534.258581.140.39数据可信
供试品溶液-2024030821批-瑞舒伐他汀钙-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min137647
-3764737.59139.8313.7237.5939.8313.72
244163
-4416344.09844.10
346450
-4645046.38146.38
431014
-3101430.96830.97
538529
-3852938.47238.47
641520
-4152041.45941.46
10min157542
-5754257.45759.774.3757.5459.864.38
262650
-6265062.55762.66
363209
-6320963.11563.22
457295
-5729557.21057.28
558149
-5814958.06358.15
660324
-6032460.23560.33
15min164164
-6416464.06966.253.4064.2866.473.41
268011
-6801167.91068.15
369204
-6920469.10269.34
463561
-6356163.46763.66
565613
-6561365.51665.73
667510
-6751067.41067.64
20min167909
-6790967.80869.433.0668.1669.803.07
270481
-7048170.37770.76
371115
-7111571.01071.41
465980
-6598065.88266.22
570497
-7049770.39370.75
671239
-7123971.13371.51
30min168770
-6877068.66871.383.3469.1771.903.34
272946
-7294672.83873.38
372230
-7223072.12372.68
468315
-6831568.21468.70
574202
-7420274.09274.61
672465
-7246572.35872.89
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min172365
-7236572.25874.413.6772.9175.093.67
274927
-7492774.81675.52
375787
-7578775.67576.39
470366
-7036670.26270.90
578045
-7804577.92978.61
675629
-7562975.51776.21
60min174893
-7489374.78276.144.8775.6076.984.84
274788
-7478874.67775.55
376968
-7696876.85477.74
471494
-7149471.38872.18
582703
-8270382.58183.43
676642
-7664276.52877.39
极限177713
-7771377.59879.812.2678.5880.832.28
279628
-7962879.51080.55
381470
-8147081.34982.40
477889
-7788977.77478.72
581723
-8172381.60282.64
681159
-8115981.03982.07
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.086682
86682+0		86367
86367+0		86524
86524+0		86493
86493+0		86553
86553+0		865240.14
210.8486844
86844+0		86667
86667+0		867560.15
单位质量响应值RSD%判断
7865.828003.321.23数据可信
供试品溶液-2024030821批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17653
7653+0		-76538.6819.1214.378.689.1214.38
29090
9090+0		-909010.31110.31
39335
9335+0		-933510.58910.59
46189
6189+0		-61897.0217.02
57593
7593+0		-75938.6138.61
68373
8373+0		-83739.4989.50
10min111605
11605+0		-1160513.16413.504.2913.1813.524.30
212551
12551+0		-1255114.23714.26
312452
12452+0		-1245214.12514.15
411383
11383+0		-1138312.91212.93
511441
11441+0		-1144112.97813.00
612001
12001+0		-1200113.61313.63
15min112624
12624+0		-1262414.32014.763.5314.3714.813.52
213318
13318+0		-1331815.10715.16
313627
13627+0		-1362715.45815.51
412493
12493+0		-1249314.17214.22
512729
12729+0		-1272914.43914.49
613291
13291+0		-1329115.07715.13
20min113279
13279+0		-1327915.06315.422.9315.1415.502.95
213795
13795+0		-1379515.64915.74
313801
13801+0		-1380115.65515.74
412930
12930+0		-1293014.66714.74
513787
13787+0		-1378715.63915.72
613952
13952+0		-1395215.82715.91
30min113568
13568+0		-1356815.39115.943.4915.5016.053.49
214275
14275+0		-1427516.19316.32
314123
14123+0		-1412316.02116.14
413339
13339+0		-1333915.13115.24
514519
14519+0		-1451916.47016.58
614478
14478+0		-1447816.42316.54
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min114290
14290+0		-1429016.21016.754.1216.3616.904.12
214874
14874+0		-1487416.87317.03
315060
15060+0		-1506017.08317.24
413788
13788+0		-1378815.64115.78
515312
15312+0		-1531217.36917.52
615285
15285+0		-1528517.33917.50
60min114879
14879+0		-1487916.87817.055.2517.0617.245.20
214529
14529+0		-1452916.48116.68
315204
15204+0		-1520417.24717.44
413990
13990+0		-1399015.87016.05
516320
16320+0		-1632018.51318.70
615280
15280+0		-1528017.33317.53
极限115357
15357+0		-1535717.42017.982.3017.6418.212.30
215736
15736+0		-1573617.85018.08
315946
15946+0		-1594618.08918.32
415577
15577+0		-1557717.67017.88
516255
16255+0		-1625518.43918.67
616247
16247+0		-1624718.43018.66
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.5998555
98918
98852
98817
98893
988070.15
211.5698842
98861
988520.02
单位质量响应值RSD%判断
8525.198551.210.22数据可信
供试品溶液-2024030821批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min140341
-4034140.37342.565.8240.3742.565.82
241482
-4148241.51541.51
346063
-4606346.10046.10
440138
-4013840.17040.17
545030
-4503045.06645.07
642085
-4208542.11842.12
10min157570
-5757057.61660.995.5957.7161.085.59
260474
-6047460.52260.61
362514
-6251462.56462.67
463446
-6344663.49663.59
565148
-6514865.20065.30
656480
-5648056.52556.62
15min162985
-6298563.03564.935.6463.2565.165.64
266189
-6618966.24266.47
367560
-6756067.61467.86
462169
-6216962.21862.45
570022
-7002270.07870.32
660346
-6034660.39460.61
20min165039
-6503965.09168.016.4665.4568.396.45
269697
-6969769.75270.13
371967
-7196772.02472.42
464709
-6470964.76065.13
573554
-7355473.61274.01
662778
-6277862.82863.18
30min166890
-6689066.94368.785.5867.4569.305.57
270037
-7003770.09370.62
372078
-7207872.13572.69
465667
-6566765.71966.23
573708
-7370873.76774.33
663954
-6395464.00564.50
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min169869
-6986969.92471.415.8570.5872.095.84
271938
-7193871.99572.68
374845
-7484574.90475.62
468031
-6803168.08568.74
577245
-7724577.30678.03
666212
-6621266.26566.90
60min168275
-6827568.32971.335.2469.1472.165.25
272830
-7283072.88873.73
374213
-7421374.27275.15
468410
-6841068.46469.27
576452
-7645276.51377.41
667448
-6744867.50268.28
极限177169
-7716977.23077.542.0678.1978.542.08
279762
-7976279.82580.83
377543
-7754377.60578.65
477090
-7709077.15178.11
578355
-7835578.41779.49
674949
-7494975.00875.94
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.086623
86623+0		86590
86590+0		86730
86730+0		86570
86570+0		86685
86685+0		866400.08
210.8486757
86757+0		86910
86910+0		868340.13
单位质量响应值RSD%判断
7876.368010.521.20数据可信
供试品溶液-2024030821批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17961
7961+0		-79619.0219.495.539.029.495.54
28255
8255+0		-82559.3549.35
39106
9106+0		-910610.31810.32
47909
7909+0		-79098.9628.96
58729
8729+0		-87299.8919.89
68293
8293+0		-82939.3979.40
10min111754
11754+0		-1175413.31813.774.7513.3413.794.74
212159
12159+0		-1215913.77713.80
312093
12093+0		-1209313.70213.73
412682
12682+0		-1268214.37014.39
512896
12896+0		-1289614.61214.63
611335
11335+0		-1133512.84412.86
15min112792
12792+0		-1279214.49514.665.6914.5414.715.69
213349
13349+0		-1334915.12615.18
313338
13338+0		-1333815.11315.17
412310
12310+0		-1231013.94814.00
513904
13904+0		-1390415.75415.81
611927
11927+0		-1192713.51413.56
20min112914
12914+0		-1291414.63315.326.7914.7115.406.79
213866
13866+0		-1386615.71115.80
314320
14320+0		-1432016.22616.31
412957
12957+0		-1295714.68114.76
514702
14702+0		-1470216.65916.75
612351
12351+0		-1235113.99514.07
30min113439
13439+0		-1343915.22815.365.4615.3415.485.45
213619
13619+0		-1361915.43215.55
314279
14279+0		-1427916.17916.30
413002
13002+0		-1300214.73214.85
514457
14457+0		-1445716.38116.51
612521
12521+0		-1252114.18714.30
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min113943
13943+0		-1394315.79915.955.5915.9516.105.59
214127
14127+0		-1412716.00716.16
314735
14735+0		-1473516.69616.86
413371
13371+0		-1337115.15115.30
515180
15180+0		-1518017.20017.36
613116
13116+0		-1311614.86215.00
60min113827
13827+0		-1382715.66716.054.7515.8516.244.74
214423
14423+0		-1442316.34316.53
314499
14499+0		-1449916.42916.62
413552
13552+0		-1355215.35615.54
515226
15226+0		-1522617.25217.45
613481
13481+0		-1348115.27515.45
极限115553
15553+0		-1555317.62317.402.7917.8417.632.79
215841
15841+0		-1584117.94918.18
315361
15361+0		-1536117.40517.64
415186
15186+0		-1518617.20717.42
515598
15598+0		-1559817.67417.91
614612
14612+0		-1461216.55716.77
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.5998864
98976
98917
98954
98962
989350.05
211.5698942
98754
988480.14
单位质量响应值RSD%判断
8536.248550.870.13数据可信
供试品溶液-2024030921批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min136255
-3625536.26141.518.5736.2641.518.57
241074
-4107441.08141.08
343542
-4354243.54943.55
446455
-4645546.46346.46
542570
-4257042.57742.58
639128
-3912839.13439.13
10min160278
-6027860.28860.983.9860.3761.073.98
259874
-5987459.88459.98
359361
-5936159.37159.47
465829
-6582965.84065.94
559746
-5974659.75659.85
660729
-6072960.73960.83
15min165497
-6549765.50866.351.2165.7266.581.21
267651
-6765167.66267.89
365526
-6552665.53765.77
466286
-6628666.29766.55
566448
-6644866.45966.69
666645
-6664566.65666.88
20min167428
-6742867.43969.624.3067.8069.994.29
268547
-6854768.55868.93
367713
-6771367.72468.10
475425
-7542575.43775.83
568522
-6852268.53368.91
670004
-7000470.01670.39
30min170584
-7058470.59672.083.0971.1172.613.09
269160
-6916069.17169.70
374029
-7402974.04174.57
474845
-7484574.85775.42
570783
-7078370.79571.32
673025
-7302573.03773.56
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min172065
-7206572.07773.423.4672.7474.113.45
274091
-7409174.10374.78
370262
-7026270.27470.96
476675
-7667576.68877.42
571531
-7153171.54372.23
675823
-7582375.83676.52
60min172782
-7278272.79474.443.0673.6275.303.03
278161
-7816178.17479.02
371449
-7144971.46172.31
474751
-7475174.76375.66
574507
-7450774.51975.36
674932
-7493274.94475.80
极限178897
-7889778.91077.821.9979.9078.841.96
280394
-8039480.40781.43
376140
-7614076.15377.16
477141
-7714177.15478.22
577141
-7714177.15478.16
677141
-7714177.15478.18
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.086847
86847+0		86850
86850+0		86720
86720+0		86796
86796+0		86784
86784+0		867990.07
210.8486613
86613+0		86540
86540+0		865760.06
单位质量响应值RSD%判断
7890.827986.720.86数据可信
供试品溶液-2024030921批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17219
7219+0		-72198.1849.339.708.189.339.73
28057
8057+0		-80579.1349.13
38702
8702+0		-87029.8669.87
49443
9443+0		-944310.70610.71
58354
8354+0		-83549.4719.47
67585
7585+0		-75858.5998.60
10min111980
11980+0		-1198013.58213.714.2413.6013.734.24
211899
11899+0		-1189913.49013.51
311636
11636+0		-1163613.19213.21
413098
13098+0		-1309814.84914.87
511884
11884+0		-1188413.47313.49
612064
12064+0		-1206413.67713.70
15min112855
12855+0		-1285514.57414.921.4514.6214.971.47
213330
13330+0		-1333015.11215.16
313021
13021+0		-1302114.76214.81
413315
13315+0		-1331515.09515.15
513168
13168+0		-1316814.92914.98
613289
13289+0		-1328915.06615.12
20min113516
13516+0		-1351615.32315.816.6515.4015.906.63
213751
13751+0		-1375115.59015.67
313276
13276+0		-1327615.05115.14
415775
15775+0		-1577517.88417.97
513415
13415+0		-1341515.20915.29
613953
13953+0		-1395315.81915.90
30min114020
14020+0		-1402015.89516.677.2416.0116.807.22
213620
13620+0		-1362015.44115.56
315057
15057+0		-1505717.07017.19
416635
16635+0		-1663518.85918.99
514609
14609+0		-1460916.56216.68
614305
14305+0		-1430516.21816.34
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min114359
14359+0		-1435916.27916.654.6616.4316.804.66
214474
14474+0		-1447416.40916.56
314141
14141+0		-1414116.03216.19
415858
15858+0		-1585817.97918.15
514130
14130+0		-1413016.01916.17
615139
15139+0		-1513917.16317.32
60min114237
14237+0		-1423716.14116.855.7816.3317.055.73
216284
16284+0		-1628418.46118.65
314178
14178+0		-1417816.07416.26
415561
15561+0		-1556117.64217.85
514447
14447+0		-1444716.37916.57
614487
14487+0		-1448716.42416.62
极限115596
15596+0		-1559617.68117.622.9017.9017.852.89
215567
15567+0		-1556717.64917.88
314656
14656+0		-1465616.61616.84
415816
15816+0		-1581617.93118.18
515816
15816+0		-1581617.93118.16
615816
15816+0		-1581617.93118.16
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.5998579
98678
98725
98840
98954
987550.15
211.5697987
98135
980610.11
单位质量响应值RSD%判断
8520.718482.790.32数据可信
供试品溶液-2024030921批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min141136
-4113641.34543.2510.4641.3543.2610.47
248593
-4859348.84048.84
339715
-3971539.91739.92
448011
-4801148.25548.26
537470
-3747037.66137.66
643285
-4328543.50543.51
10min159867
-5986760.17261.904.0560.2662.004.05
261935
-6193562.25062.36
362830
-6283063.15063.24
464289
-6428964.61664.72
557497
-5749757.79057.87
663106
-6310663.42763.52
15min164633
-6463364.96267.473.3165.1967.703.31
266297
-6629766.63466.88
368317
-6831768.66568.89
468375
-6837568.72368.97
564898
-6489865.22865.44
670259
-7025970.61670.85
20min166481
-6648166.81970.263.9867.1970.643.97
267953
-6795368.29968.69
372134
-7213472.50172.88
471073
-7107371.43571.84
568164
-6816468.51168.87
673599
-7359973.97374.37
30min169086
-6908669.43872.692.6669.9673.232.65
272670
-7267073.04073.59
371512
-7151271.87672.42
472533
-7253372.90273.46
573331
-7333173.70474.21
674802
-7480275.18375.74
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min170818
-7081871.17873.932.4271.8574.632.40
272218
-7221872.58573.29
375546
-7554675.93076.63
474062
-7406274.43975.16
575050
-7505075.43276.10
673659
-7365974.03474.76
60min16542
-65426.57563.0443.947.4163.9043.37
271822
-7182272.18773.06
375153
-7515375.53576.41
473310
-7331073.68374.57
573937
-7393774.31375.15
675551
-7555175.93576.83
极限171784
-7178472.14979.724.9372.9980.734.96
278931
-7893179.33380.36
380827
-8082781.23882.28
481158
-8115881.57182.62
580381
-8038180.79081.80
682847
-8284783.26984.33
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
111.086497
86497+0		86618
86618+0		86527
86527+0		86748
86748+0		86690
86690+0		866160.13
210.8486167
86167+0		86021
86021+0		860940.12
单位质量响应值RSD%判断
7874.187942.250.61数据可信
供试品溶液-2024030921批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18013
8013+0		-80139.1199.2510.639.129.2510.62
29274
9274+0		-927410.55510.55
37224
7224+0		-72248.2218.22
49024
9024+0		-902410.27010.27
57258
7258+0		-72588.2608.26
67982
7982+0		-79829.0849.08
10min111431
11431+0		-1143113.00913.354.8213.0313.374.82
211823
11823+0		-1182313.45513.48
312280
12280+0		-1228013.97613.99
412212
12212+0		-1221213.89813.92
510759
10759+0		-1075912.24512.26
611862
11862+0		-1186213.50013.52
15min112768
12768+0		-1276814.53114.642.5914.5814.702.59
212646
12646+0		-1264614.39214.45
313002
13002+0		-1300214.79714.85
413099
13099+0		-1309914.90814.96
512386
12386+0		-1238614.09614.14
613304
13304+0		-1330415.14115.19
20min112884
12884+0		-1288414.66315.444.2414.7415.524.20
212833
12833+0		-1283314.60514.69
313926
13926+0		-1392615.84915.93
413643
13643+0		-1364315.52715.61
513968
13968+0		-1396815.89715.97
614156
14156+0		-1415616.11116.19
30min113045
13045+0		-1304514.84615.763.0114.9615.882.99
213846
13846+0		-1384615.75815.88
313965
13965+0		-1396515.89316.01
413946
13946+0		-1394615.87215.99
514051
14051+0		-1405115.99116.10
614243
14243+0		-1424316.21016.33
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min113556
13556+0		-1355615.42815.902.7515.5716.062.73
213679
13679+0		-1367915.56815.72
314505
14505+0		-1450516.50816.66
414161
14161+0		-1416116.11616.27
514256
14256+0		-1425616.22416.37
613693
13693+0		-1369315.58415.74
60min169495
69495+0		-6949579.09126.6296.6079.2726.8095.91
213593
13593+0		-1359315.47015.66
314313
14313+0		-1431316.28916.48
414256
14256+0		-1425616.22416.42
514241
14241+0		-1424116.20716.39
614423
14423+0		-1442316.41416.60
极限113954
13954+0		-1395415.88117.465.0616.2417.704.72
215073
15073+0		-1507317.15417.38
315369
15369+0		-1536917.49117.72
416152
16152+0		-1615218.38218.61
515626
15626+0		-1562617.78418.00
615857
15857+0		-1585718.04718.27
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