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)5补液体积(ml)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%
111.1593305
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%
5min133762
28071+5691*1		-3376234.58337.566.0334.5837.566.03
239146
32622+6524*1		-3914640.09840.10
334219
28647+5572*1		-3421935.05135.05
438244
31950+6294*1		-3824439.17439.17
537824
31578+6246*1		-3782438.74438.74
636800
30733+6067*1		-3680037.69537.70
10min161712
51356+10356*1		-6171263.21364.103.8863.4164.313.89
265602
54626+10976*1		-6560267.19867.42
359961
50015+9946*1		-5996161.41961.61
461724
51488+10236*1		-6172463.22563.44
565586
54702+10884*1		-6558667.18167.40
660874
50727+10147*1		-6087462.35562.56
15min173182
60912+12270*1		-7318274.96275.362.5575.5175.932.56
274391
62178+12213*1		-7439176.20076.80
372341
60575+11766*1		-7234174.10074.64
472324
60220+12104*1		-7232474.08374.65
577010
64340+12670*1		-7701078.88379.47
672205
60119+12086*1		-7220573.96174.52
20min177377
64725+12652*1		-7737779.25979.462.5880.2280.442.58
278720
65970+12750*1		-7872080.63581.65
376518
63960+12558*1		-7651878.37979.33
475904
63731+12173*1		-7590477.75078.73
581023
67668+13355*1		-8102382.99484.02
675910
63535+12375*1		-7591077.75678.72
30min185355
71055+14300*1		-8535587.43188.782.5488.8390.202.54
288351
73725+14626*1		-8835190.50091.97
385606
71472+14134*1		-8560687.68889.07
485104
70829+14275*1		-8510487.17488.59
590387
75387+15000*1		-9038792.58594.07
685215
71056+14159*1		-8521587.28888.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min191711
76549+15162*1		-9171193.94292.862.5395.8394.782.52
290640
75758+14882*1		-9064092.84594.81
389175
74498+14677*1		-8917591.34493.21
489477
74573+14904*1		-8947791.65393.55
594644
78870+15774*1		-9464496.94698.95
688307
73575+14732*1		-8830790.45592.34
60min193230
77697+15533*1		-9323095.49895.611.8197.9198.051.83
294868
79187+15681*1		-9486897.17599.66
392261
77084+15177*1		-9226194.50596.88
491209
76134+15075*1		-9120993.42795.83
595750
79670+16080*1		-9575098.079100.62
692746
77318+15428*1		-9274695.00297.39
极限194327
78822+15505*1		-9432796.62196.821.7799.5699.781.78
294395
78932+15463*1		-9439596.69199.72
394151
78695+15456*1		-9415196.44199.34
492426
77337+15089*1		-9242694.67497.60
597562
81672+15890*1		-9756299.935103.02
694256
78779+15477*1		-9425696.54899.46
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)5补液体积(ml)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%
111.3890129
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%
5min13170
-31703.6083.4218.913.613.4218.94
22804
-28043.1913.19
33441
-34413.9163.92
43153
-31533.5883.59
51959
-19592.2292.23
63493
-34933.9753.98
10min17565
-75658.6098.354.728.638.374.75
27216
-72168.2128.23
37424
-74248.4498.47
47231
-72318.2298.25
56793
-67937.7317.74
67803
-78038.8808.90
15min17967
-79679.0679.529.359.139.599.31
27973
-79739.0739.14
38101
-81019.2199.29
47832
-78328.9138.98
58420
-84209.5829.64
69910
-991011.27811.35
20min18119
-81199.2409.6112.749.369.7312.67
28184
-81849.3149.43
37699
-76998.7628.88
47800
-78008.8778.99
58267
-82679.4089.52
610591
-1059112.05312.19
30min17511
-75118.5489.0810.198.729.2510.15
27574
-75748.6198.78
37966
-79669.0659.23
47601
-76018.6508.81
57620
-76208.6728.83
69607
-960710.93311.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min18067
-80679.1809.2410.449.409.4710.40
27767
-77678.8399.05
37930
-79309.0249.24
47419
-74198.4438.66
57761
-77618.8329.04
69796
-979611.14811.41
60min17417
-74178.4419.119.998.719.399.87
27655
-76558.7128.97
37505
-75058.5418.81
47468
-74688.4998.76
58695
-86959.89510.15
69315
-931510.60110.92
极限17906
-79068.9978.915.569.319.235.66
27684
-76848.7459.06
37675
-76758.7349.05
47468
-74688.4998.81
57561
-75618.6058.92
68662
-86629.85710.24
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)5补液体积(ml)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%
111.1592661
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%
5min137593
31272+6321*1		-3759338.77639.935.9938.7839.935.99
237860
31496+6364*1		-3786039.05139.05
336913
30769+6144*1		-3691338.07538.07
441658
34704+6954*1		-4165842.96942.97
541626
34693+6933*1		-4162642.93642.94
636612
30599+6013*1		-3661237.76437.76
10min163359
52941+10418*1		-6335965.35364.832.1765.5765.062.17
263578
53051+10527*1		-6357865.57965.80
361441
51166+10275*1		-6144163.37463.59
463594
53196+10398*1		-6359465.59565.83
564280
53658+10622*1		-6428066.30366.54
660886
50691+10195*1		-6088662.80263.01
15min174812
62557+12255*1		-7481277.16675.392.5877.7475.972.57
275260
62921+12339*1		-7526077.62878.21
371286
59687+11599*1		-7128673.52974.09
473300
61436+11864*1		-7330075.60676.21
573349
61485+11864*1		-7334975.65776.26
670518
58992+11526*1		-7051872.73773.30
20min179881
66876+13005*1		-7988182.39578.463.2383.4079.463.21
277018
64612+12406*1		-7701879.44180.45
373994
62313+11681*1		-7399476.32277.29
476603
64187+12416*1		-7660379.01380.04
576029
64001+12028*1		-7602978.42179.45
672896
61356+11540*1		-7289675.19076.15
30min185934
71787+14147*1		-8593488.63888.211.8290.1089.651.82
286643
72199+14444*1		-8664389.36990.82
382806
69153+13653*1		-8280685.41286.81
484782
71022+13760*1		-8478287.45088.91
587158
72646+14512*1		-8715889.90191.36
685805
71643+14162*1		-8580588.50589.89
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min192203
76902+15301*1		-9220395.10493.232.8397.0695.162.82
291840
76657+15183*1		-9184094.73096.68
386054
72009+14045*1		-8605488.76290.63
490659
75582+15077*1		-9065993.51295.46
592785
77621+15164*1		-9278595.70597.67
688766
74074+14692*1		-8876691.55993.43
60min195317
79704+15613*1		-9531798.31697.391.54100.8099.831.55
296447
80767+15680*1		-9644799.482101.96
392154
77062+15092*1		-9215495.05497.42
494652
79211+15441*1		-9465297.630100.10
594090
78795+15295*1		-9409097.05199.54
693828
78573+15255*1		-9382896.78099.16
极限195719
80089+15630*1		-9571998.73197.461.19101.76100.441.21
295742
80159+15583*1		-9574298.755101.78
393082
77843+15239*1		-9308296.01198.90
493996
78815+15181*1		-9399696.95499.96
594843
79448+15395*1		-9484397.827100.86
693550
78162+15388*1		-9355096.49499.41
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)5补液体积(ml)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%
111.3889573
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%
5min13241
-32413.7033.3020.753.703.3020.69
23123
-31233.5693.57
33433
-34333.9233.92
42710
-27103.0973.10
53039
-30393.4733.47
61765
-17652.0172.02
10min17349
-73498.3978.095.098.428.115.13
27081
-70818.0918.11
37504
-75048.5758.60
46701
-67017.6577.67
57234
-72348.2668.29
66603
-66037.5457.56
15min17945
-79459.0789.080.829.159.150.88
27989
-79899.1299.19
38040
-80409.1879.26
47845
-78458.9649.02
57956
-79569.0919.16
67929
-79299.0609.11
20min18096
-80969.2519.241.799.379.361.78
27946
-79469.0809.20
38254
-82549.4329.55
48271
-82719.4519.56
58005
-80059.1479.26
67962
-79629.0989.20
30min17542
-75428.6188.831.868.799.001.82
27564
-75648.6438.81
37906
-79069.0349.21
47796
-77968.9089.07
57766
-77668.8749.04
67786
-77868.8979.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min17478
-74788.5458.791.598.769.011.59
27764
-77648.8729.09
37827
-78278.9449.17
47758
-77588.8659.08
57689
-76898.7869.00
67661
-76618.7548.96
60min16970
-69707.9648.513.428.238.773.34
27599
-75998.6838.95
37714
-77148.8149.09
47457
-74578.5218.78
57449
-74498.5128.78
67477
-74778.5448.80
极限17446
-74468.5088.661.548.828.971.51
27672
-76728.7669.08
37548
-75488.6258.95
47605
-76058.6909.00
57735
-77358.8389.15
67453
-74538.5168.82
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