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%
117.99201852
201852+0
203243
203243+0
203241
203241+0
201310
201310+0
200757
200757+0
2020810.56
218.09198841
198841+0
199548
199548+0
1991940.26
单位质量响应值RSD%判断
11232.9611011.281.41数据可信
供试品溶液-2025010521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%
5min170137
67897+2240*1
-7013735.29836.663.6535.3036.663.65
274803
72331+2472*1
-7480337.64637.65
374736
72319+2417*1
-7473637.61237.61
474589
72184+2405*1
-7458937.53837.54
574019
71727+2292*1
-7401937.25237.25
668833
66692+2141*1
-6883334.64234.64
10min1133956
128783+5173*1
-13395667.41668.642.0467.8169.052.04
2141490
135882+5608*1
-14149071.20871.63
3136789
131575+5214*1
-13678968.84269.26
4134039
128939+5100*1
-13403967.45867.87
5136637
131390+5247*1
-13663768.76569.18
6135469
130652+4817*1
-13546968.17868.56
15min1161483
152047+9436*1
-16148381.27082.210.7982.4183.380.81
2165142
155272+9870*1
-16514283.11184.32
3163794
154317+9477*1
-16379482.43383.62
4164090
154711+9379*1
-16409082.58283.75
5163096
153942+9154*1
-16309682.08183.26
6162529
153506+9023*1
-16252981.79682.94
20min1176534
163885+12649*1
-17653488.84489.212.6690.8991.292.61
2181972
168635+13337*1
-18197291.58193.71
3182494
169495+12999*1
-18249491.84493.94
4177517
165164+12353*1
-17751789.33991.42
5169749
157968+11781*1
-16974985.43087.52
6175247
163243+12004*1
-17524788.19790.25
30min1186690
166912+19778*1
-18669093.95695.351.6996.9998.421.68
2194967
174050+20917*1
-19496798.121101.27
3189706
169897+19809*1
-18970695.47398.59
4190667
171100+19567*1
-19066795.95799.03
5186227
167283+18944*1
-18622793.72296.76
6188512
169559+18953*1
-18851294.87297.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1195814
162420+33394*1
-19581498.54798.151.40102.62102.291.36
2195510
161574+33936*1
-19551098.394102.64
3198093
164355+33738*1
-19809399.694103.87
4192192
160057+32135*1
-19219296.724100.87
5191320
159647+31673*1
-19132096.286100.37
6197250
164781+32469*1
-19725099.270103.36
60min1192133
150405+41728*1
-19213396.69598.320.97101.87103.550.95
2197318
153896+43422*1
-19731899.304104.64
3194709
152717+41992*1
-19470997.991103.28
4195013
153506+41507*1
-19501398.144103.36
5196066
154737+41329*1
-19606698.674103.82
6196962
155555+41407*1
-19696299.125104.31
极限1188577
140707+47870*1
-18857794.90596.102.76101.15102.422.64
2195863
145615+50248*1
-19586398.572105.01
3192851
144386+48465*1
-19285197.056103.43
4190038
142729+47309*1
-19003895.640101.95
5182194
137283+44911*1
-18219491.69397.94
6196169
148041+48128*1
-19616998.726105.02
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%
117.99201040
201040+0
200613
200613+0
201360
201360+0
202091
202091+0
201062
201062+0
2012330.28
218.09203040
203040+0
202184
202184+0
2026120.30
单位质量响应值RSD%判断
11185.8311200.220.10数据可信
供试品溶液-2025010521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126891
25873+1018*1
-2689113.44613.5613.0713.4513.5613.08
233033
31816+1217*1
-3303316.51816.52
323388
22594+794*1
-2338811.69511.69
425494
24477+1017*1
-2549412.74812.75
529276
28234+1042*1
-2927614.63914.64
624573
23506+1067*1
-2457312.28712.29
10min145953
44523+1430*1
-4595322.97822.973.2323.1323.123.29
248011
46472+1539*1
-4801124.00724.19
343642
42194+1448*1
-4364221.82221.95
445844
44397+1447*1
-4584422.92323.07
546898
45424+1474*1
-4689823.45123.61
645254
43740+1514*1
-4525422.62822.77
15min152821
51067+1754*1
-5282126.41226.462.0526.8226.862.09
253440
51585+1855*1
-5344026.72227.17
350814
49070+1744*1
-5081425.40925.78
453083
51304+1779*1
-5308326.54326.94
553781
52029+1752*1
-5378126.89227.32
653531
51668+1863*1
-5353126.76727.16
20min155582
53622+1960*1
-5558227.79328.471.8528.4929.161.88
258589
56477+2112*1
-5858929.29630.04
356073
54070+2003*1
-5607328.03828.69
456968
54937+2031*1
-5696828.48629.18
556973
54978+1995*1
-5697328.48829.21
657395
55297+2098*1
-5739528.69929.38
30min156522
54041+2481*1
-5652228.26328.982.4129.2730.002.40
258093
55386+2707*1
-5809329.04830.12
356487
53988+2499*1
-5648728.24529.21
458332
55779+2553*1
-5833229.16830.18
560263
57679+2584*1
-6026330.13331.17
658036
55407+2629*1
-5803629.02030.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min154460
50975+3485*1
-5446027.23228.562.6828.5529.902.61
257493
53676+3817*1
-5749328.74830.14
357530
53886+3644*1
-5753028.76730.05
456781
53230+3551*1
-5678128.39229.72
559159
55580+3579*1
-5915929.58130.95
657305
53698+3607*1
-5730528.65429.98
60min158112
53771+4341*1
-5811229.05829.391.6330.6831.041.57
259959
55305+4654*1
-5995929.98131.70
359290
54770+4520*1
-5929029.64731.25
457946
53488+4458*1
-5794628.97530.62
557735
53428+4307*1
-5773528.86930.57
659606
55087+4519*1
-5960629.80531.45
极限160468
55485+4983*1
-6046830.23629.871.7132.1831.861.65
260953
55799+5154*1
-6095330.47832.53
359132
54314+4818*1
-5913229.56831.50
458551
53515+5036*1
-5855129.27731.25
558848
54027+4821*1
-5884829.42631.45
660520
55518+5002*1
-6052030.26232.24
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%
117.99200783
200783+0
201487
201487+0
201684
201684+0
201713
201713+0
200673
200673+0
2012680.25
218.09203590
203590+0
200651
200651+0
2021201.03
单位质量响应值RSD%判断
11187.7711173.020.10数据可信
供试品溶液-2025010521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1810
810+0
-8100.4050.21110.100.410.21110.12
2805
805+0
-8050.4030.40
3
+0
-0.0000.00
4
+0
-0.0000.00
5934
934+0
-9340.4680.47
6
+0
-0.0000.00
10min12753
2184+569*1
-27531.3781.364.191.381.364.29
22727
2102+625*1
-27271.3651.37
32689
2056+633*1
-26891.3461.35
42726
2109+617*1
-27261.3651.36
52867
2229+638*1
-28671.4351.44
62517
1893+624*1
-25171.2601.26
15min13265
2536+729*1
-32651.6341.543.731.651.553.68
22934
2340+594*1
-29341.4691.49
33016
2351+665*1
-30161.5101.52
43126
2454+672*1
-31261.5651.58
53062
2476+586*1
-30621.5331.55
63012
2323+689*1
-30121.5081.52
20min13344
2651+693*1
-33441.6741.662.231.711.702.44
23335
2646+689*1
-33351.6691.71
33270
2552+718*1
-32701.6371.67
43291
2606+685*1
-32911.6471.68
53430
2720+710*1
-34301.7171.76
63215
2481+734*1
-32151.6091.64
30min13285
2557+728*1
-32851.6441.653.621.701.703.62
23396
2676+720*1
-33961.7001.75
33303
2614+689*1
-33031.6531.70
43252
2570+682*1
-32521.6281.68
53468
2721+747*1
-34681.7361.79
63122
2499+623*1
-31221.5631.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min13319
2558+761*1
-33191.6611.713.931.741.783.59
23458
2674+784*1
-34581.7311.80
33466
2642+824*1
-34661.7351.80
43623
2620+1003*1
-36231.8141.88
53317
2628+689*1
-33171.6601.74
63264
2502+762*1
-32641.6341.70
60min13334
2519+815*1
-33341.6691.661.631.761.751.34
23398
2464+934*1
-33981.7011.79
33291
2487+804*1
-32911.6471.74
43312
2548+764*1
-33121.6581.75
53238
2468+770*1
-32381.6211.72
63347
2503+844*1
-33471.6751.76
极限13405
2575+830*1
-34051.7051.806.401.821.926.02
23390
2579+811*1
-33901.6971.81
33509
2649+860*1
-35091.7571.86
43539
2704+835*1
-35391.7721.88
53883
3037+846*1
-38831.9442.06
63903
2711+1192*1
-39031.9542.06
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%
117.99200957
200957+0
199932
199932+0
200228
200228+0
200065
200065+0
199883
199883+0
2002130.22
218.09198878
198878+0
199556
199556+0
1992170.25
单位质量响应值RSD%判断
11129.1311012.550.75数据可信
供试品溶液-2025010521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117422
16762+660*1
-174228.8088.803.848.818.803.82
216668
16015+653*1
-166688.4278.43
317737
17054+683*1
-177378.9678.97
416567
15945+622*1
-165678.3768.38
517819
17162+657*1
-178199.0099.01
618244
17531+713*1
-182449.2249.22
10min131638
30951+687*1
-3163815.99515.583.3116.0915.673.32
229276
28397+879*1
-2927614.80114.89
331844
30933+911*1
-3184416.09916.20
430286
29354+932*1
-3028615.31215.40
530290
29372+918*1
-3029015.31415.41
631542
30605+937*1
-3154215.94716.05
15min138588
37334+1254*1
-3858819.50919.133.6719.7819.403.65
236424
35307+1117*1
-3642418.41518.67
337840
36629+1211*1
-3784019.13119.41
436259
35154+1105*1
-3625918.33118.59
539973
38761+1212*1
-3997320.20920.48
637961
36805+1156*1
-3796119.19219.47
20min141988
40662+1326*1
-4198821.22821.152.1121.7221.642.09
240856
39554+1302*1
-4085620.65521.12
342586
41076+1510*1
-4258621.53022.02
441802
40491+1311*1
-4180221.13421.60
542968
41600+1368*1
-4296821.72322.22
640818
39483+1335*1
-4081820.63621.13
30min144332
42804+1528*1
-4433222.41322.241.6123.1422.961.53
244463
42899+1564*1
-4446322.47923.17
342708
41232+1476*1
-4270821.59222.32
444551
43018+1533*1
-4455122.52323.23
544266
42726+1540*1
-4426622.37923.12
643660
42072+1588*1
-4366022.07322.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min147595
45713+1882*1
-4759524.06224.301.0425.0425.261.03
247600
45757+1843*1
-4760024.06525.01
348677
46647+2030*1
-4867724.60925.58
447878
45994+1884*1
-4787824.20525.16
548677
46734+1943*1
-4867724.60925.59
647947
46067+1880*1
-4794724.24025.21
60min147536
45374+2162*1
-4753624.03324.452.1325.2825.692.01
248912
46190+2722*1
-4891224.72825.94
349987
47687+2300*1
-4998725.27226.52
448743
46515+2228*1
-4874324.64325.86
547636
45437+2199*1
-4763624.08325.34
647358
45161+2197*1
-4735823.94325.18
极限149527
47041+2486*1
-4952725.03925.121.5526.5526.631.45
250250
47774+2476*1
-5025025.40526.89
348999
46577+2422*1
-4899924.77226.30
450296
47869+2427*1
-5029625.42826.92
550458
48002+2456*1
-5045825.51027.04
648615
46219+2396*1
-4861524.57826.08
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