美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制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1000
标示量(mg)80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%
117.99202803
202803+0
203303
203303+0
202528
202528+0
202843
202843+0
203730
203730+0
2030410.24
218.09202925
202925+0
202191
202191+0
2025580.26
单位质量响应值RSD%判断
11286.3311197.240.57数据可信
供试品溶液-2025010421批-磷酸盐溶液(pH7.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190372
87838+2534*1
-9037244.99443.579.0944.9943.579.09
281099
78507+2592*1
-8109940.37740.38
392371
89406+2965*1
-9237145.98945.99
474659
72116+2543*1
-7465937.17137.17
590914
87985+2929*1
-9091445.26345.26
695655
92536+3119*1
-9565547.62447.62
10min1147300
141297+6003*1
-14730073.33672.123.2273.8472.603.25
2141077
135470+5607*1
-14107770.23870.69
3149117
143020+6097*1
-14911774.24174.75
4137236
131978+5258*1
-13723668.32668.74
5146519
140595+5924*1
-14651972.94873.45
6147868
141947+5921*1
-14786873.61974.15
15min1168471
158364+10107*1
-16847183.87784.703.1985.1985.983.20
2164369
154733+9636*1
-16436981.83583.06
3171630
161325+10305*1
-17163085.45086.79
4164800
155491+9309*1
-16480082.04983.22
5178687
168202+10485*1
-17868788.96390.28
6172767
162642+10125*1
-17276786.01687.36
20min1178710
165472+13238*1
-17871088.97591.102.4691.2293.332.48
2181230
168049+13181*1
-18123090.22992.37
3182971
169525+13446*1
-18297191.09693.38
4178346
165845+12501*1
-17834688.79390.88
5189021
175394+13627*1
-18902194.10896.41
6187624
174033+13591*1
-18762493.41395.72
30min1194984
172174+22810*1
-19498497.07795.892.46100.3199.122.48
2187415
164510+22905*1
-18741593.30996.45
3192481
170005+22476*1
-19248195.83199.13
4187263
166164+21099*1
-18726393.23396.30
5199587
176771+22816*1
-19958799.369102.72
6193832
171624+22208*1
-19383296.50399.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1194131
159235+34896*1
-19413196.65295.950.86100.97100.250.94
2191628
156446+35182*1
-19162895.40699.58
3192161
157655+34506*1
-19216195.671100.03
4190361
157119+33242*1
-19036194.77598.88
5193223
159163+34060*1
-19322396.200100.65
6194791
160499+34292*1
-19479196.981101.39
60min1188074
144727+43347*1
-18807493.63795.511.6999.02100.881.65
2195325
150687+44638*1
-19532597.247102.48
3189839
146158+43681*1
-18983994.51599.94
4189069
146965+42104*1
-18906994.13299.29
5195239
149767+45472*1
-19523997.204102.72
6193531
149899+43632*1
-19353196.354101.84
极限1189698
139917+49781*1
-18969894.44596.441.21100.87102.871.19
2194313
144890+49423*1
-19431396.743103.06
3192718
142488+50230*1
-19271895.949102.42
4194039
146007+48032*1
-19403996.606102.81
5196669
147133+49536*1
-19666997.916104.52
6194758
145566+49192*1
-19475896.964103.53
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制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1000
标示量(mg)80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%
117.99202413
202413+0
200292
200292+0
202967
202967+0
202389
202389+0
202584
202584+0
2021290.53
218.09201410
201410+0
202573
202573+0
2019920.41
单位质量响应值RSD%判断
11235.6311165.950.44数据可信
供试品溶液-2025010421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122659
21640+1019*1
-2265911.32212.7015.8011.3212.7015.81
226542
25185+1357*1
-2654213.26313.26
323497
21806+1691*1
-2349711.74111.74
431786
30196+1590*1
-3178615.88315.88
527434
25692+1742*1
-2743413.70913.71
620581
19412+1169*1
-2058110.28410.28
10min144938
43616+1322*1
-4493822.45523.064.2022.5823.204.26
246872
45406+1466*1
-4687223.42123.57
343839
42395+1444*1
-4383921.90622.04
449112
47603+1509*1
-4911224.54124.72
547227
45795+1432*1
-4722723.59923.75
644934
43577+1357*1
-4493422.45322.57
15min151669
49984+1685*1
-5166925.81926.502.1826.1926.902.25
253428
51641+1787*1
-5342826.69727.11
351993
50207+1786*1
-5199325.98026.35
453879
52057+1822*1
-5387926.92327.37
554666
52901+1765*1
-5466627.31627.73
652585
50899+1686*1
-5258526.27626.64
20min154915
53056+1859*1
-5491527.44128.281.6428.1028.981.65
256862
54808+2054*1
-5686228.41329.12
356384
54348+2036*1
-5638428.17528.84
457094
55009+2085*1
-5709428.52929.28
556690
54674+2016*1
-5669028.32729.05
657647
55712+1935*1
-5764728.80629.46
30min154768
52331+2437*1
-5476827.36727.722.2628.3328.722.11
255977
53372+2605*1
-5597727.97128.99
355771
53164+2607*1
-5577127.86828.84
453596
50965+2631*1
-5359626.78127.85
555370
52857+2513*1
-5537027.66828.70
657335
54533+2802*1
-5733528.65029.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min155678
52297+3381*1
-5567827.82227.711.8629.0929.021.70
254303
50700+3603*1
-5430327.13528.47
355759
52553+3206*1
-5575927.86229.15
454122
50629+3493*1
-5412227.04428.41
556077
52523+3554*1
-5607728.02129.36
656739
53322+3417*1
-5673928.35229.65
60min157372
53150+4222*1
-5737228.66828.451.8730.2530.081.69
256408
52008+4400*1
-5640828.18729.82
357968
53551+4417*1
-5796828.96630.56
455047
50602+4445*1
-5504727.50629.17
557217
52929+4288*1
-5721728.59130.24
657628
53481+4147*1
-5762828.79630.41
极限157396
52715+4681*1
-5739628.68028.552.2330.5830.492.03
258594
53617+4977*1
-5859429.27931.22
357825
52973+4852*1
-5782528.89530.81
456070
51118+4952*1
-5607028.01829.99
555154
50532+4622*1
-5515427.56029.53
657752
53102+4650*1
-5775228.85830.79
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制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1000
标示量(mg)80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%
117.99202311
202311+0
201504
201504+0
202078
202078+0
201971
201971+0
202344
202344+0
2020420.17
218.09202871
202871+0
201200
201200+0
2020360.59
单位质量响应值RSD%判断
11230.7911168.380.40数据可信
供试品溶液-2025010421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1932
932+0
-9320.4660.5011.000.470.5011.03
21055
1055+0
-10550.5270.53
31006
1006+0
-10060.5030.50
4856
856+0
-8560.4280.43
5961
961+0
-9610.4800.48
61174
1174+0
-11740.5870.59
10min12754
2150+604*1
-27541.3761.402.711.381.412.67
22720
2088+632*1
-27201.3591.37
32866
2252+614*1
-28661.4321.44
42802
2154+648*1
-28021.4001.41
52928
2283+645*1
-29281.4631.47
62786
2170+616*1
-27861.3921.40
15min13065
2398+667*1
-30651.5321.613.821.551.643.96
23169
2481+688*1
-31691.5841.60
33184
2465+719*1
-31841.5911.61
43432
2689+743*1
-34321.7151.74
53252
2561+691*1
-32521.6251.65
63272
2585+687*1
-32721.6351.66
20min13272
2529+743*1
-32721.6351.694.191.671.734.28
23231
2496+735*1
-32311.6151.65
33350
2607+743*1
-33501.6741.71
43363
2605+758*1
-33631.6811.72
53613
2881+732*1
-36131.8061.85
63485
2711+774*1
-34851.7421.78
30min13251
2478+773*1
-32511.6251.702.731.681.762.72
23461
2690+771*1
-34611.7301.79
33330
2581+749*1
-33301.6641.72
43487
2702+785*1
-34871.7431.80
53397
2635+762*1
-33971.6981.76
63465
2657+808*1
-34651.7321.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min13226
2455+771*1
-32261.6121.652.461.691.722.35
23324
2521+803*1
-33241.6611.74
33228
2443+785*1
-32281.6131.69
43221
2446+775*1
-32211.6101.69
53408
2582+826*1
-34081.7031.78
63362
2549+813*1
-33621.6801.76
60min13316
2498+818*1
-33161.6571.694.401.751.794.06
23438
2610+828*1
-34381.7181.81
33291
2465+826*1
-32911.6451.74
43655
2756+899*1
-36551.8271.92
53240
2522+718*1
-32401.6191.72
63393
2557+836*1
-33931.6961.79
极限13353
2494+859*1
-33531.6761.742.961.791.862.84
23442
2582+860*1
-34421.7201.83
33490
2628+862*1
-34901.7441.86
43669
2770+899*1
-36691.8341.95
53486
2686+800*1
-34861.7421.86
63494
2626+868*1
-34941.7461.86
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制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1000
标示量(mg)80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%
117.99202868
202868+0
201245
201245+0
201551
201551+0
201841
201841+0
202114
202114+0
2019240.31
218.09201247
201247+0
201260
201260+0
2012540.01
单位质量响应值RSD%判断
11224.2411125.150.63数据可信
供试品溶液-2025010421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116482
15829+653*1
-164828.2557.3313.208.267.3313.22
211967
11967+0
-119675.9945.99
313714
13109+605*1
-137146.8696.87
413355
13355+0
-133556.6896.69
516893
16271+622*1
-168938.4618.46
615362
14717+645*1
-153627.6947.69
10min131121
30060+1061*1
-3112115.58715.024.4415.6815.104.50
228100
27226+874*1
-2810014.07414.14
329585
28680+905*1
-2958514.81814.89
429070
28198+872*1
-2907014.56014.63
531674
31043+631*1
-3167415.86415.96
630358
29449+909*1
-3035815.20515.29
15min136360
35272+1088*1
-3636018.21118.362.9918.4818.613.03
235898
34819+1079*1
-3589817.98018.20
336125
35060+1065*1
-3612518.09418.33
436024
34955+1069*1
-3602418.04318.28
538806
37670+1136*1
-3880619.43619.71
636785
35604+1181*1
-3678518.42418.68
20min140958
39722+1236*1
-4095820.51420.772.2020.9821.222.22
240942
39695+1247*1
-4094220.50620.93
341901
40615+1286*1
-4190120.98721.43
440584
39369+1215*1
-4058420.32720.76
543083
41795+1288*1
-4308321.57922.06
641311
40052+1259*1
-4131120.69121.15
30min144048
42552+1496*1
-4404822.06222.481.2922.7623.161.23
244819
43246+1573*1
-4481922.44823.10
345275
43722+1553*1
-4527522.67723.35
444708
42968+1740*1
-4470822.39323.05
544658
43066+1592*1
-4465822.36823.09
645730
44064+1666*1
-4573022.90423.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min147804
45971+1833*1
-4780423.94323.831.3624.8824.761.39
247010
45170+1840*1
-4701023.54624.45
347865
46013+1852*1
-4786523.97424.90
446550
44767+1783*1
-4655023.31524.23
548020
46149+1871*1
-4802024.05125.03
648195
46348+1847*1
-4819524.13925.08
60min148663
46525+2138*1
-4866324.37324.872.0025.5826.071.94
248542
46352+2190*1
-4854224.31325.47
351071
48512+2559*1
-5107125.58026.77
449629
47442+2187*1
-4962924.85726.03
549550
47344+2206*1
-4955024.81826.06
650474
48206+2268*1
-5047425.28126.49
极限149626
47020+2606*1
-4962624.85625.531.5326.3327.001.45
251050
48528+2522*1
-5105025.56927.00
351770
49292+2478*1
-5177025.93027.41
451460
48996+2464*1
-5146025.77427.22
551350
48816+2534*1
-5135025.71927.24
650527
48072+2455*1
-5052725.30726.80
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