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%
118.03207211
207211+0
207971
207971+0
207375
207375+0
207369
207369+0
207284
207284+0
2074420.15
218.07207430
207430+0
207788
207788+0
2076090.13
单位质量响应值RSD%判断
11505.3811489.150.10数据可信
供试品溶液-2025010221批-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17752
7752+0
-77523.7744.5213.113.774.5213.17
28788
8788+0
-87884.2784.28
38796
8796+0
-87964.2824.28
410088
10088+0
-100884.9114.91
59027
8449+578*1
-90274.3944.39
611248
11248+0
-112485.4765.48
10min125331
24510+821*1
-2533112.33113.858.0212.3713.908.04
226891
26177+714*1
-2689113.09113.14
328981
28184+797*1
-2898114.10814.16
430270
29461+809*1
-3027014.73514.79
527677
26917+760*1
-2767713.47313.52
631561
30757+804*1
-3156115.36415.42
15min136530
35546+984*1
-3653017.78319.836.5917.9620.036.61
238596
37612+984*1
-3859618.78918.98
342042
40962+1080*1
-4204220.46620.67
441979
40901+1078*1
-4197920.43520.65
541299
40237+1062*1
-4129920.10420.30
643913
42741+1172*1
-4391321.37721.61
20min144884
43698+1186*1
-4488421.85024.135.0622.2324.565.08
248898
47621+1277*1
-4889823.80424.21
351439
50136+1303*1
-5143925.04125.47
450958
49642+1316*1
-5095824.80625.25
549847
48528+1319*1
-4984724.26624.69
651443
49974+1469*1
-5144325.04225.51
30min155064
53485+1579*1
-5506426.80529.184.7327.4229.874.76
258058
56451+1607*1
-5805828.26328.93
362194
60492+1702*1
-6219430.27630.99
460584
58937+1647*1
-6058429.49230.21
561791
60112+1679*1
-6179130.08030.77
661908
60234+1674*1
-6190830.13730.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min164889
62761+2128*1
-6488931.58834.304.0332.5135.324.07
270135
67578+2557*1
-7013534.14235.12
371886
69263+2623*1
-7188634.99436.04
471505
69185+2320*1
-7150534.80935.86
571878
69381+2497*1
-7187834.99036.02
672464
69656+2808*1
-7246435.27636.36
60min172627
69615+3012*1
-7262735.35537.974.1336.6239.374.16
276141
72963+3178*1
-7614137.06538.43
380243
76862+3381*1
-8024339.06240.50
478238
75016+3222*1
-7823838.08639.52
579125
75888+3237*1
-7912538.51839.93
681607
76174+5433*1
-8160739.72641.20
极限180939
77489+3450*1
-8093939.40141.262.9141.0643.082.98
282876
79189+3687*1
-8287640.34442.12
387436
83517+3919*1
-8743642.56444.43
484653
80876+3777*1
-8465341.20943.07
586447
82634+3813*1
-8644742.08243.92
686223
82553+3670*1
-8622341.97343.89
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%
118.03207715
207715+0
207359
207359+0
207342
207342+0
207223
207223+0
207191
207191+0
2073660.11
218.07205914
205914+0
205418
205418+0
2056660.18
单位质量响应值RSD%判断
11501.1611381.630.74数据可信
供试品溶液-2025010221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18273
8273+0
-82734.0474.3111.944.054.3111.96
28040
8040+0
-80403.9333.93
310664
10664+0
-106645.2175.22
49426
9426+0
-94264.6114.61
58432
8432+0
-84324.1254.12
67987
7987+0
-79873.9073.91
10min127108
26260+848*1
-2710813.26113.694.4213.3113.744.46
227054
26241+813*1
-2705413.23513.28
330028
29158+870*1
-3002814.68914.75
428548
27687+861*1
-2854813.96514.02
528322
27006+1316*1
-2832213.85513.90
626800
25873+927*1
-2680013.11013.15
15min139987
38815+1172*1
-3998719.56119.601.3419.7519.801.37
240358
39005+1353*1
-4035819.74319.93
340899
38576+2323*1
-4089920.00720.23
439710
38521+1189*1
-3971019.42619.63
540080
38932+1148*1
-4008019.60719.81
639344
38041+1303*1
-3934419.24719.44
20min147979
46586+1393*1
-4797923.47123.690.8323.8824.110.87
248537
47154+1383*1
-4853723.74424.15
349128
46402+2726*1
-4912824.03324.48
448433
47047+1386*1
-4843323.69324.12
548387
46990+1397*1
-4838723.67024.09
648127
46611+1516*1
-4812723.54323.95
30min159839
57935+1904*1
-5983929.27329.190.9729.9429.870.91
259561
57523+2038*1
-5956129.13729.81
359184
56757+2427*1
-5918428.95229.66
459274
57307+1967*1
-5927428.99629.68
559378
57552+1826*1
-5937829.04729.73
660739
58591+2148*1
-6073929.71330.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min171864
69036+2828*1
-7186435.15534.441.2736.1535.441.22
270285
67574+2711*1
-7028534.38335.38
369793
67144+2649*1
-6979334.14235.17
469244
66538+2706*1
-6924433.87434.88
570716
68207+2509*1
-7071634.59435.60
670467
67770+2697*1
-7046734.47235.47
60min176793
73370+3423*1
-7679337.56637.550.8638.9538.940.80
276939
73605+3334*1
-7693937.63839.02
375712
72400+3312*1
-7571237.03838.45
476345
73044+3301*1
-7634537.34738.73
577456
73937+3519*1
-7745637.89139.28
677355
73745+3610*1
-7735537.84139.22
极限183307
79430+3877*1
-8330740.75340.670.2542.5642.480.25
283085
79360+3725*1
-8308540.64442.44
383262
79361+3901*1
-8326240.73142.55
482812
79024+3788*1
-8281240.51142.31
583022
79660+3362*1
-8302240.61442.42
683360
79476+3884*1
-8336040.77942.58
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%
118.03207345
207345+0
206500
206500+0
207114
207114+0
207312
207312+0
205997
205997+0
2068540.29
218.07206077
206077+0
207084
207084+0
2065800.35
单位质量响应值RSD%判断
11472.7711432.210.26数据可信
供试品溶液-2025010221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1
+0
-0.0000.00-0.000.00-
2
+0
-0.0000.00
3
+0
-0.0000.00
4
+0
-0.0000.00
5
+0
-0.0000.00
6
+0
-0.0000.00
10min13227
2405+822*1
-32271.5771.5012.331.581.5012.24
22805
2070+735*1
-28051.3711.37
33274
2507+767*1
-32741.6001.60
43235
2430+805*1
-32351.5811.58
52446
1734+712*1
-24461.1951.20
63476
2712+764*1
-34761.6991.70
15min14665
3739+926*1
-46652.2802.177.162.302.197.22
24273
3452+821*1
-42732.0882.10
34685
3810+875*1
-46852.2902.31
44430
3599+831*1
-44302.1652.18
53897
3099+798*1
-38971.9041.92
64705
3800+905*1
-47052.2992.32
20min15251
4317+934*1
-52512.5662.485.612.612.525.64
24743
3856+887*1
-47432.3182.36
35171
4269+902*1
-51712.5272.57
45234
4348+886*1
-52342.5582.60
54691
3810+881*1
-46912.2932.33
65364
4467+897*1
-53642.6212.67
30min15581
4551+1030*1
-55812.7272.725.122.802.795.17
25495
4539+956*1
-54952.6852.75
35623
4691+932*1
-56232.7482.82
45549
4598+951*1
-55492.7122.78
55132
4188+944*1
-51322.5082.57
66022
4843+1179*1
-60222.9433.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min15707
4639+1068*1
-57072.7892.874.092.892.974.12
25805
4802+1003*1
-58052.8372.93
35957
4918+1039*1
-59572.9113.01
46256
4807+1449*1
-62563.0573.16
55572
4549+1023*1
-55722.7232.81
65988
4934+1054*1
-59882.9263.03
60min15910
4746+1164*1
-59102.8883.2728.153.023.4026.90
25789
4738+1051*1
-57892.8292.95
35954
4872+1082*1
-59542.9103.04
45839
4814+1025*1
-58392.8542.99
510527
9508+1019*1
-105275.1455.26
66125
5048+1077*1
-61252.9933.13
极限16251
4995+1256*1
-62513.0552.992.923.223.162.65
26054
4952+1102*1
-60542.9593.12
36169
5003+1166*1
-61693.0153.18
46086
4978+1108*1
-60862.9743.14
55832
4756+1076*1
-58322.8503.03
66348
5216+1132*1
-63483.1023.27
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%
118.03206022
206022+0
205910
205910+0
205373
205373+0
206202
206202+0
205158
205158+0
2057330.22
218.07204122
204122+0
204389
204389+0
2042560.10
单位质量响应值RSD%判断
11410.5911303.600.67数据可信
供试品溶液-2025010221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1
+0
-0.0000.00-0.000.00-
2
+0
-0.0000.00
3
+0
-0.0000.00
4
+0
-0.0000.00
5
+0
-0.0000.00
6
+0
-0.0000.00
10min13404
2655+749*1
-34041.6781.4710.091.681.4710.11
22836
2093+743*1
-28361.3981.40
32618
1825+793*1
-26181.2901.29
42926
2157+769*1
-29261.4421.44
52797
2020+777*1
-27971.3781.38
63265
2560+705*1
-32651.6091.61
15min14799
3945+854*1
-47992.3652.175.322.382.195.29
24266
3416+850*1
-42662.1022.12
34112
3201+911*1
-41122.0262.04
44503
3591+912*1
-45032.2192.24
54344
3443+901*1
-43442.1412.16
64404
3601+803*1
-44042.1702.19
20min15470
4566+904*1
-54702.6962.534.332.742.574.37
25118
4198+920*1
-51182.5222.56
34777
3813+964*1
-47772.3542.39
45189
4205+984*1
-51892.5572.60
55097
4138+959*1
-50972.5122.55
65171
4301+870*1
-51712.5482.59
30min16024
5054+970*1
-60242.9692.774.043.042.844.01
25426
4476+950*1
-54262.6742.74
35385
4390+995*1
-53852.6542.72
45604
4578+1026*1
-56042.7622.83
55623
4607+1016*1
-56232.7712.84
65621
4690+931*1
-56212.7702.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min16129
5086+1043*1
-61293.0202.843.843.132.943.89
25698
4656+1042*1
-56982.8082.90
35551
4451+1100*1
-55512.7362.83
45588
4485+1103*1
-55882.7542.85
55914
4816+1098*1
-59142.9153.01
65669
4705+964*1
-56692.7942.89
60min16245
5169+1076*1
-62453.0782.883.983.223.013.95
25821
4785+1036*1
-58212.8693.00
35524
4388+1136*1
-55242.7222.85
45849
4688+1161*1
-58492.8833.01
55776
4635+1141*1
-57762.8472.98
65833
4814+1019*1
-58332.8753.01
极限16379
5228+1151*1
-63793.1443.002.943.323.163.03
26107
4949+1158*1
-61073.0103.17
35821
4628+1193*1
-58212.8693.02
46041
4832+1209*1
-60412.9773.14
56076
4903+1173*1
-60762.9943.16
66128
5047+1081*1
-61283.0203.18
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