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%
111.10191654
191654+0		192006
192006+0		191378
191378+0		191265
191265+0		191069
191069+0		1914740.20
211.06191238
191238+0		191611
191611+0		1914240.14
单位质量响应值RSD%判断
17249.9117307.780.24数据可信
供试品溶液-Y012651批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16599
6599+0		-65993.4293.579.233.433.589.26
27500
7500+0		-75003.8973.90
37672
7672+0		-76723.9863.99
46217
6217+0		-62173.2303.23
57078
7078+0		-70783.6773.68
66212
6212+0		-62123.2283.23
10min110558
10558+0		-105585.4865.405.165.505.425.18
210999
10999+0		-109995.7155.74
310851
10851+0		-108515.6385.66
49776
9776+0		-97765.0795.10
510494
10494+0		-104945.4525.47
69728
9728+0		-97285.0545.07
15min112597
12597+0		-125976.5456.503.176.596.553.16
212845
12845+0		-128456.6746.73
312333
12333+0		-123336.4086.46
412733
12733+0		-127336.6166.66
512739
12739+0		-127396.6196.67
611780
11780+0		-117806.1216.17
20min113475
13475+0		-134757.0017.021.067.097.111.06
213663
13663+0		-136637.0997.19
313667
13667+0		-136677.1017.19
413540
13540+0		-135407.0357.12
513295
13295+0		-132956.9087.00
613439
13439+0		-134396.9827.06
30min114925
14925+0		-149257.7557.633.187.887.763.12
215149
15149+0		-151497.8718.00
313807
13807+0		-138077.1747.30
414818
14818+0		-148187.6997.82
514615
14615+0		-146157.5937.72
614831
14831+0		-148317.7067.82
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min115833
15833+0		-158338.2268.193.378.398.363.26
214717
14717+0		-147177.6467.82
315937
15937+0		-159378.2808.45
415911
15911+0		-159118.2678.43
516204
16204+0		-162048.4198.59
616000
16000+0		-160008.3138.47
60min116229
16229+0		-162298.4328.052.708.658.262.66
215140
15140+0		-151407.8668.08
315673
15673+0		-156738.1438.36
415161
15161+0		-151617.8778.09
515239
15239+0		-152397.9188.13
615487
15487+0		-154878.0478.25
极限116764
16764+0		-167648.7108.403.528.978.663.40
216515
16515+0		-165158.5818.84
315736
15736+0		-157368.1768.44
416630
16630+0		-166308.6408.89
515322
15322+0		-153227.9618.22
616010
16010+0		-160108.3188.57
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%
110.99432940
433958
433035
433070
431967
4329940.17
210.99431523
432325
4319240.14
单位质量响应值RSD%判断
39398.9139301.550.18数据可信
供试品溶液-Y012651批-辛伐他汀-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14114
-41140.9360.936.660.940.946.73
23951
-39510.8990.90
34071
-40710.9260.93
43743
-37430.8520.85
54564
-45641.0391.04
64177
-41770.9510.95
10min11256
-12560.2862.58139.580.292.59139.31
21203
-12030.2740.28
333961
-339617.7297.73
429459
-294596.7046.71
51176
-11760.2680.27
61026
-10260.2330.24
15min144086
-4408610.0338.0947.8110.048.1147.55
244304
-4430410.08210.09
340069
-400699.1199.17
41092
-10920.2490.29
543721
-437219.9509.96
640035
-400359.1119.12
20min147383
-4738310.78310.920.9810.8510.991.02
248335
-4833511.00011.06
348407
-4840711.01611.11
448201
-4820110.96911.01
548267
-4826710.98411.05
647429
-4742910.79410.85
30min153008
-5300812.0639.7848.2412.199.9147.71
254591
-5459112.42312.55
346663
-4666310.61910.78
41038
-10380.2360.34
550269
-5026911.44011.56
652393
-5239311.92312.04
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min150810
-5081011.5634.28146.6111.754.46141.16
21092
-10920.2490.44
357832
-5783213.16113.38
41063
-10630.2420.35
51021
-10210.2320.42
61093
-10930.2490.43
60min11040
-10400.2376.15105.460.496.35101.32
21033
-10330.2350.43
31026
-10260.2330.53
452830
-5283012.02312.13
551152
-5115211.64111.83
655039
-5503912.52512.71
极限158314
-5831413.2714.47146.7213.534.71139.95
21041
-10410.2370.43
355437
-5543712.61612.91
41078
-10780.2450.42
51060
-10600.2410.49
61025
-10250.2330.49
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%
111.10188992
188992+0		189273
189273+0		188826
188826+0		188715
188715+0		188974
188974+0		1889560.12
211.06191929
191929+0		192360
192360+0		1921440.16
单位质量响应值RSD%判断
17023.0617372.881.44数据可信
供试品溶液-Y012651批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113296
13296+0		-132966.9414.0136.066.944.0036.08
26367
6367+0		-63673.3243.32
36654
6654+0		-66543.4743.47
46137
6137+0		-61373.2043.20
56913
6913+0		-69133.6093.61
66682
6682+0		-66823.4883.49
10min19708
9708+0		-97085.0685.232.635.115.252.56
210033
10033+0		-100335.2385.26
310218
10218+0		-102185.3345.35
49759
9759+0		-97595.0955.11
59980
9980+0		-99805.2105.23
610396
10396+0		-103965.4275.45
15min112295
12295+0		-122956.4196.352.856.496.402.86
212382
12382+0		-123826.4646.51
312524
12524+0		-125246.5386.59
411593
11593+0		-115936.0526.10
512284
12284+0		-122846.4136.46
611913
11913+0		-119136.2196.27
20min112102
12102+0		-121026.3186.874.666.426.964.52
213698
13698+0		-136987.1517.23
313815
13815+0		-138157.2127.30
413215
13215+0		-132156.8996.98
513190
13190+0		-131906.8866.97
612965
12965+0		-129656.7696.85
30min114617
14617+0		-146177.6317.471.777.777.601.81
214225
14225+0		-142257.4267.55
314587
14587+0		-145877.6157.74
413962
13962+0		-139627.2897.41
514335
14335+0		-143357.4847.61
614171
14171+0		-141717.3987.52
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min115132
15132+0		-151327.9007.974.778.088.144.68
215508
15508+0		-155088.0968.26
315699
15699+0		-156998.1968.36
414520
14520+0		-145207.5807.74
516333
16333+0		-163338.5278.69
614437
14437+0		-144377.5377.70
60min116026
16026+0		-160268.3678.361.678.598.571.69
216218
16218+0		-162188.4678.68
316375
16375+0		-163758.5498.76
415689
15689+0		-156898.1918.39
516043
16043+0		-160438.3758.59
615736
15736+0		-157368.2158.42
极限115558
15558+0		-155588.1228.082.258.398.342.15
214862
14862+0		-148627.7598.02
315302
15302+0		-153027.9898.25
415606
15606+0		-156068.1478.39
515825
15825+0		-158258.2628.52
615699
15699+0		-156998.1968.45
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%
110.99427103
426644
426208
426130
425571
4263310.14
210.99422364
422797
4225800.08
单位质量响应值RSD%判断
38792.6338451.320.63数据可信
供试品溶液-Y012651批-辛伐他汀-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13981
-39810.9230.9811.100.920.9811.38
23857
-38570.8940.89
33757
-37570.8710.87
44161
-41610.9650.96
54904
-49041.1371.14
64694
-46941.0881.09
10min11080
-10800.2500.268.740.260.277.77
21002
-10020.2320.24
31098
-10980.2550.26
41193
-11930.2770.28
51160
-11600.2690.28
61285
-12850.2980.30
15min145148
-4514810.4683.63144.2710.473.64143.86
21044
-10440.2420.25
344444
-4444410.30510.31
41071
-10710.2480.26
51037
-10370.2400.25
61158
-11580.2690.28
20min145332
-4533210.5117.4975.0910.587.5275.00
248436
-4843611.23111.24
349493
-4949311.47611.54
41020
-10200.2370.24
548421
-4842111.22711.24
61063
-10630.2460.26
30min153226
-5322612.3415.87105.2912.465.94104.11
249104
-4910411.38611.46
31059
-10590.2460.37
446303
-4630310.73610.75
51119
-11190.2590.33
61021
-10210.2370.25
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min11029
-10290.2390.2610.170.430.3618.73
21106
-11060.2560.39
31356
-13560.3140.44
41135
-11350.2630.33
51146
-11460.2660.34
61052
-10520.2440.26
60min11108
-11080.2570.264.440.450.3616.87
21066
-10660.2470.38
31152
-11520.2670.40
41126
-11260.2610.33
51214
-12140.2810.36
61103
-11030.2560.27
极限156238
-5623813.0404.25146.0813.234.35143.77
249352
-4935211.44311.58
31189
-11890.2760.41
41085
-10850.2520.32
51024
-10240.2370.31
61116
-11160.2590.27
点击查看处理图标(自动生成)
　
原始图谱下载图谱(谢超君 于 2025-02-20 15:18:34 完成)
生成报告数据部分下载报告(谢超君 于 2025-02-20 15:18:55 完成)
Current page cost:50 ms