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)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.1593305
93305+0		93485
93485+0		93295
93295+0		93909
93909+0		93826
93826+0		935640.31
211.2393196
93196+0		93073
93073+0		931340.10
单位质量响应值RSD%判断
8391.398293.320.84数据可信
供试品溶液-JT1707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%
5min128071
28071+0		-2807128.75431.346.0528.7531.346.06
232622
32622+0		-3262233.41533.42
328647
28647+0		-2864729.34429.34
431950
31950+0		-3195032.72732.73
531578
31578+0		-3157832.34632.35
630733
30733+0		-3073331.48031.48
10min151356
51356+0		-5135652.60553.423.8752.6553.473.87
254626
54626+0		-5462655.95556.01
350015
50015+0		-5001551.23151.28
451488
51488+0		-5148852.74052.79
554702
54702+0		-5470256.03256.09
650727
50727+0		-5072751.96152.01
15min160912
60912+0		-6091262.39362.882.6562.5363.022.65
262178
62178+0		-6217863.69063.84
360575
60575+0		-6057562.04862.18
460220
60220+0		-6022061.68561.83
564340
64340+0		-6434065.90566.05
660119
60119+0		-6011961.58161.72
20min164725
64725+0		-6472566.29966.512.4866.5466.762.48
265970
65970+0		-6597067.57467.83
363960
63960+0		-6396065.51665.75
463731
63731+0		-6373165.28165.53
567668
67668+0		-6766869.31469.57
663535
63535+0		-6353565.08065.32
30min171055
71055+0		-7105572.78374.012.5973.1374.372.59
273725
73725+0		-7372575.51875.89
371472
71472+0		-7147273.21073.56
470829
70829+0		-7082972.55272.91
575387
75387+0		-7538777.22177.59
671056
71056+0		-7105672.78473.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min176549
76549+0		-7654978.41177.482.5178.8877.962.51
275758
75758+0		-7575877.60178.09
374498
74498+0		-7449876.31076.78
474573
74573+0		-7457376.38776.86
578870
78870+0		-7887080.78881.29
673575
73575+0		-7357575.36475.84
60min177697
77697+0		-7769779.58779.741.7280.1980.351.73
279187
79187+0		-7918781.11381.74
377084
77084+0		-7708478.95979.55
476134
76134+0		-7613477.98678.59
579670
79670+0		-7967081.60882.24
677318
77318+0		-7731879.19879.80
极限178822
78822+0		-7882280.73980.961.8081.4781.701.80
278932
78932+0		-7893280.85281.61
378695
78695+0		-7869580.60981.34
477337
77337+0		-7733779.21879.95
581672
81672+0		-8167283.65884.43
678779
78779+0		-7877980.69581.42
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)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.3890129
90339
90140
89810
89867
900570.25
211.4490027
89902
899640.10
单位质量响应值RSD%判断
7913.627863.990.45数据可信
供试品溶液-JT1707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%
5min15691
-56916.4766.906.086.486.906.06
26524
-65247.4247.42
35572
-55726.3416.34
46294
-62947.1637.16
56246
-62467.1087.11
66067
-60676.9046.90
10min110356
-1035611.78511.863.9911.8011.883.98
210976
-1097612.49112.50
39946
-994611.31911.33
410236
-1023611.64911.66
510884
-1088412.38612.40
610147
-1014711.54711.56
15min112270
-1227013.96313.872.4313.9913.902.42
212213
-1221313.89913.93
311766
-1176613.39013.42
412104
-1210413.77513.81
512670
-1267014.41914.45
612086
-1208613.75413.78
20min112652
-1265214.39814.393.2014.4514.443.18
212750
-1275014.51014.57
312558
-1255814.29114.34
412173
-1217313.85313.91
513355
-1335515.19815.25
612375
-1237514.08314.14
30min114300
-1430016.27416.412.3316.3516.482.34
214626
-1462616.64516.73
314134
-1413416.08516.16
414275
-1427516.24516.32
515000
-1500017.07017.15
614159
-1415916.11316.19
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min115162
-1516217.25517.102.7017.3617.202.69
214882
-1488216.93617.04
314677
-1467716.70316.81
414904
-1490416.96117.07
515774
-1577417.95118.06
614732
-1473216.76516.87
60min115533
-1553317.67717.632.3517.8117.772.35
215681
-1568117.84517.98
315177
-1517717.27217.40
415075
-1507517.15617.29
516080
-1608018.29918.44
615428
-1542817.55717.69
极限115505
-1550517.64517.621.6417.8117.781.65
215463
-1546317.59717.76
315456
-1545617.58917.75
415089
-1508917.17217.33
515890
-1589018.08318.25
615477
-1547717.61317.77
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)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.1592661
92661+0		92583
92583+0		92633
92633+0		92741
92741+0		92703
92703+0		926640.07
211.2392629
92629+0		92846
92846+0		927380.17
单位质量响应值RSD%判断
8310.678258.060.45数据可信
供试品溶液-JT1707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%
5min131272
31272+0		-3127232.25633.275.9632.2633.275.95
231496
31496+0		-3149632.48732.49
330769
30769+0		-3076931.73731.74
434704
34704+0		-3470435.79635.80
534693
34693+0		-3469335.78535.78
630599
30599+0		-3059931.56231.56
10min152941
52941+0		-5294154.60754.102.3254.6654.162.32
253051
53051+0		-5305154.72054.77
351166
51166+0		-5116652.77652.83
453196
53196+0		-5319654.87054.93
553658
53658+0		-5365855.34655.41
650691
50691+0		-5069152.28652.34
15min162557
62557+0		-6255764.52563.102.5564.6763.252.55
262921
62921+0		-6292164.90165.05
359687
59687+0		-5968761.56561.71
461436
61436+0		-6143663.36963.52
561485
61485+0		-6148563.42063.57
658992
58992+0		-5899260.84860.99
20min166876
66876+0		-6687668.98065.903.0169.2366.153.00
264612
64612+0		-6461266.64566.90
362313
62313+0		-6231364.27464.52
464187
64187+0		-6418766.20766.46
564001
64001+0		-6400166.01566.27
661356
61356+0		-6135663.28763.53
30min171787
71787+0		-7178774.04673.661.7374.4174.021.73
272199
72199+0		-7219974.47174.84
369153
69153+0		-6915371.32971.68
471022
71022+0		-7102273.25773.62
572646
72646+0		-7264674.93275.30
671643
71643+0		-7164373.89774.24
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min176902
76902+0		-7690279.32277.852.7979.8178.332.79
276657
76657+0		-7665779.06979.56
372009
72009+0		-7200974.27574.74
475582
75582+0		-7558277.96078.45
577621
77621+0		-7762180.06380.56
674074
74074+0		-7407476.40576.87
60min179704
79704+0		-7970482.21281.501.5782.8382.121.57
280767
80767+0		-8076783.30883.93
377062
77062+0		-7706279.48780.08
479211
79211+0		-7921181.70382.32
578795
78795+0		-7879581.27481.90
678573
78573+0		-7857381.04581.64
极限180089
80089+0		-8008982.60981.571.2483.3782.321.25
280159
80159+0		-8015982.68183.44
377843
77843+0		-7784380.29281.02
478815
78815+0		-7881581.29582.05
579448
79448+0		-7944881.94882.71
678162
78162+0		-7816280.62181.35
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)1.5补液体积(ml)1.5
对照品批号DSMF-387-240606对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.3889573
89540
89500
89773
89439
895650.15
211.4489690
89757
897240.06
单位质量响应值RSD%判断
7870.397843.010.25数据可信
供试品溶液-JT1707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%
5min16321
-63217.2237.386.197.227.386.20
26364
-63647.2727.27
36144
-61447.0207.02
46954
-69547.9467.95
56933
-69337.9227.92
66013
-60136.8716.87
10min110418
-1041811.90411.891.5111.9211.901.52
210527
-1052712.02912.04
310275
-1027511.74111.75
410398
-1039811.88111.89
510622
-1062212.13712.15
610195
-1019511.64911.66
15min112255
-1225514.00313.612.7914.0413.642.80
212339
-1233914.09914.13
311599
-1159913.25413.28
411864
-1186413.55713.59
511864
-1186413.55713.59
611526
-1152613.17013.20
20min113005
-1300514.86013.924.4614.9213.974.45
212406
-1240614.17614.23
311681
-1168113.34713.40
412416
-1241614.18714.24
512028
-1202813.74413.80
611540
-1154013.18613.24
30min114147
-1414716.16516.132.4816.2516.202.46
214444
-1444416.50516.58
313653
-1365315.60115.68
413760
-1376015.72315.80
514512
-1451216.58216.66
614162
-1416216.18216.26
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min115301
-1530117.48417.043.1717.5917.143.17
215183
-1518317.34917.46
314045
-1404516.04916.15
415077
-1507717.22817.33
515164
-1516417.32717.43
614692
-1469216.78816.89
60min115613
-1561317.84017.591.4617.9817.721.48
215680
-1568017.91718.05
315092
-1509217.24517.37
415441
-1544117.64417.78
515295
-1529517.47717.61
615255
-1525517.43117.56
极限115630
-1563017.86017.601.1718.0317.761.17
215583
-1558317.80617.97
315239
-1523917.41317.57
415181
-1518117.34717.51
515395
-1539517.59117.76
615388
-1538817.58317.74
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