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%
117.99206367
206367+0
206915
206915+0
206614
206614+0
203420
203420+0
206739
206739+0
2060110.71
2 18.09204793
204793+0
205654
205654+0
2052240.30
单位质量响应值RSD%判断
11451.4211344.610.67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%
5min179862
77109+2753*1
-7986239.21642.646.3539.2242.646.35
282579
79913+2666*1
-8257940.55040.55
391593
88456+3137*1
-9159344.97744.98
483611
80786+2825*1
-8361141.05741.06
593260
90051+3209*1
-9326045.79545.80
690084
87226+2858*1
-9008444.23644.24
10min1137743
132187+5556*1
-13774367.63971.553.7268.0772.023.73
2144619
138843+5776*1
-14461971.01571.47
3150829
144444+6385*1
-15082974.06574.56
4147339
141421+5918*1
-14733972.35172.81
5151876
145676+6200*1
-15187674.57975.09
6141802
136125+5677*1
-14180269.63270.12
15min1160560
151238+9322*1
-16056078.84382.382.8280.0383.652.82
2167546
157726+9820*1
-16754682.27483.51
3165830
155889+9941*1
-16583081.43182.75
4172452
162367+10085*1
-17245284.68385.94
5173486
163460+10026*1
-17348685.19086.53
6166727
156972+9755*1
-16672781.87183.14
20min1172905
160423+12482*1
-17290584.90590.383.5286.9792.563.51
2185161
171808+13353*1
-18516190.92393.08
3189927
175926+14001*1
-18992793.26495.49
4186576
173135+13441*1
-18657691.61893.82
5189407
175814+13593*1
-18940793.00895.29
6180335
167305+13030*1
-18033588.55490.73
30min1190338
168804+21534*1
-19033893.46694.492.4996.4797.682.45
2185056
163817+21239*1
-18505690.87294.04
3191555
169426+22129*1
-19155594.06397.33
4199009
176507+22502*1
-19900997.723100.94
5195760
173782+21978*1
-19576096.12899.45
6192785
171048+21737*1
-19278594.66797.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1190718
157421+33297*1
-19071893.65295.671.7997.7099.911.83
2193294
159213+34081*1
-19329494.91799.09
3197746
162881+34865*1
-19774697.103101.41
4196195
162052+34143*1
-19619596.342100.65
5199387
164681+34706*1
-19938797.909102.29
6191610
158515+33095*1
-19161094.09098.30
60min1189454
146272+43182*1
-18945493.03194.931.8898.12100.231.86
2189233
146385+42848*1
-18923392.92398.15
3192131
148212+43919*1
-19213194.34699.73
4197713
153521+44192*1
-19771397.087102.46
5194679
151050+43629*1
-19467995.597101.07
6196736
152769+43967*1
-19673696.607101.86
极限1197371
147768+49603*1
-19737196.91996.511.22103.04102.871.16
2196630
147148+49482*1
-19663096.555102.82
3192853
143868+48985*1
-19285394.701101.14
4199488
149509+49979*1
-19948897.959104.41
5198104
148184+49920*1
-19810497.279103.81
6194820
145932+48888*1
-19482095.666102.00
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%
117.99206015
206015+0
206066
206066+0
203530
203530+0
203229
203229+0
204556
204556+0
2046790.66
2 18.09201034
201034+0
203416
203416+0
2022250.84
单位质量响应值RSD%判断
11377.3811178.831.25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%
5min128987
27734+1253*1
-2898714.38613.835.1114.3913.835.11
228147
26849+1298*1
-2814713.96913.97
327646
26282+1364*1
-2764613.72113.72
426845
25411+1434*1
-2684513.32313.32
525825
24660+1165*1
-2582512.81712.82
629740
27652+2088*1
-2974014.76014.76
10min148818
47305+1513*1
-4881824.22823.405.2224.3923.555.21
246138
44657+1481*1
-4613822.89823.05
345659
44269+1390*1
-4565922.66122.81
448676
47067+1609*1
-4867624.15824.31
543501
41854+1647*1
-4350121.58921.73
650070
48504+1566*1
-5007024.85025.01
15min153071
51196+1875*1
-5307126.33926.622.3726.7727.032.33
253064
51284+1780*1
-5306426.33626.75
351985
50207+1778*1
-5198525.80026.20
453360
51252+2108*1
-5336026.48326.90
555144
53211+1933*1
-5514427.36827.75
655158
53220+1938*1
-5515827.37527.81
20min155060
53065+1995*1
-5506027.32628.181.6428.0528.891.58
256393
54400+1993*1
-5639327.98828.69
357189
55129+2060*1
-5718928.38329.07
457388
55199+2189*1
-5738828.48229.19
557508
55431+2077*1
-5750828.54129.23
657146
54974+2172*1
-5714628.36129.11
30min155557
52818+2739*1
-5555727.57327.901.9628.6028.921.89
255116
52586+2530*1
-5511627.35428.37
355221
52596+2625*1
-5522127.40628.41
457297
54424+2873*1
-5729728.43629.46
557698
55055+2643*1
-5769828.63529.64
656404
53759+2645*1
-5640427.99329.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min154767
51280+3487*1
-5476727.18127.963.2528.5129.293.10
255674
52260+3414*1
-5567427.63128.95
357365
53704+3661*1
-5736528.47029.78
459427
55665+3762*1
-5942729.49430.84
556184
52684+3500*1
-5618427.88429.21
654552
50950+3602*1
-5455227.07428.44
60min158756
54275+4481*1
-5875629.16128.713.0030.7930.352.84
259186
54722+4464*1
-5918629.37431.00
356275
52081+4194*1
-5627527.92929.56
460075
55528+4547*1
-6007529.81531.49
556899
52540+4359*1
-5689928.23929.87
655842
51471+4371*1
-5584227.71429.39
极限159393
54418+4975*1
-5939329.47728.991.8431.4330.951.76
259011
54093+4918*1
-5901129.28731.24
357474
52684+4790*1
-5747428.52430.46
459700
54789+4911*1
-5970029.62931.63
557547
52732+4815*1
-5754728.56130.51
657334
52413+4921*1
-5733428.45530.43
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%
117.99204036
204036+0
202692
202692+0
203321
203321+0
204690
204690+0
201220
201220+0
2031920.66
2 18.09206450
206450+0
203792
203792+0
2051210.92
单位质量响应值RSD%判断
11294.7211338.920.28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%
5min11140
1140+0
-11400.5640.3586.200.560.3486.14
2882
882+0
-8820.4360.44
3
+0
-0.0000.00
4689
689+0
-6890.3410.34
5
+0
-0.0000.00
61477
881+596*1
-14770.7300.73
10min12703
2164+539*1
-27031.3371.325.281.341.325.49
22791
2239+552*1
-27911.3801.39
32389
1792+597*1
-23891.1821.18
42690
2073+617*1
-26901.3301.33
52735
2057+678*1
-27351.3531.35
62686
1961+725*1
-26861.3281.34
15min13204
2522+682*1
-32041.5851.533.351.611.543.52
23102
2398+704*1
-31021.5341.55
32901
2201+700*1
-29011.4351.45
43089
2458+631*1
-30891.5281.55
53058
2450+608*1
-30581.5121.53
63151
2381+770*1
-31511.5581.58
20min13272
2558+714*1
-32721.6181.623.381.661.663.35
23267
2455+812*1
-32671.6161.65
33087
2324+763*1
-30871.5271.56
43266
2566+700*1
-32661.6151.65
53411
2697+714*1
-34111.6871.72
63361
2625+736*1
-33611.6621.70
30min13328
2603+725*1
-33281.6461.653.921.701.704.00
23274
2561+713*1
-32741.6191.67
33122
2363+759*1
-31221.5441.59
43482
2706+776*1
-34821.7221.78
53453
2701+752*1
-34531.7081.76
63349
2552+797*1
-33491.6561.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min13315
2449+866*1
-33151.6391.635.041.711.705.02
23336
2430+906*1
-33361.6501.72
32969
2262+707*1
-29691.4681.53
43369
2559+810*1
-33691.6661.74
53444
2630+814*1
-34441.7031.77
63331
2497+834*1
-33311.6471.72
60min13360
2478+882*1
-33601.6621.702.801.751.792.72
23549
2606+943*1
-35491.7551.85
33411
2575+836*1
-34111.6871.77
43336
2606+730*1
-33361.6501.74
53563
2755+808*1
-35631.7621.85
63403
2537+866*1
-34031.6831.78
极限13386
2519+867*1
-33861.6751.733.711.791.833.65
23512
2609+903*1
-35121.7371.85
33288
2411+877*1
-32881.6261.72
43629
2703+926*1
-36291.7951.90
53592
2767+825*1
-35921.7761.88
63535
2656+879*1
-35351.7481.86
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%
117.99206178
206178+0
205747
205747+0
206720
206720+0
204937
204937+0
205747
205747+0
2058660.32
2 18.09205891
205891+0
208699
208699+0
2072950.96
单位质量响应值RSD%判断
11443.3611459.090.10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%
5min115307
14669+638*1
-153077.4817.626.587.487.626.57
215967
15245+722*1
-159677.8047.80
315302
14604+698*1
-153027.4797.48
413866
13866+0
-138666.7776.78
516771
16052+719*1
-167718.1978.20
616350
15675+675*1
-163507.9917.99
10min129356
28402+954*1
-2935614.34814.574.0814.4314.654.08
229546
29546+0
-2954614.44114.53
329119
28213+906*1
-2911914.23214.32
428349
28349+0
-2834913.85613.93
531713
30824+889*1
-3171315.50015.59
630736
29662+1074*1
-3073615.02215.11
15min135944
34768+1176*1
-3594417.56817.901.6817.8118.141.70
236450
35372+1078*1
-3645017.81518.06
337223
36003+1220*1
-3722318.19318.43
435897
34774+1123*1
-3589717.54517.77
537260
36110+1150*1
-3726018.21118.47
636929
35768+1161*1
-3692918.04918.31
20min140889
39536+1353*1
-4088919.98519.881.9420.4220.321.94
239803
38576+1227*1
-3980319.45419.90
340526
39154+1372*1
-4052619.80720.25
439787
38722+1065*1
-3978719.44619.87
541428
40103+1325*1
-4142820.24820.71
641626
40244+1382*1
-4162620.34520.80
30min143431
41478+1953*1
-4343121.22721.251.1621.8921.911.13
243623
42054+1569*1
-4362321.32121.98
342526
40956+1570*1
-4252620.78521.45
443759
42275+1484*1
-4375921.38822.03
543971
42228+1743*1
-4397121.49122.18
643503
41838+1665*1
-4350321.26221.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min145836
43971+1865*1
-4583622.40322.821.2623.3023.721.24
246171
43797+2374*1
-4617122.56623.46
347355
45411+1944*1
-4735523.14524.04
446609
44755+1854*1
-4660922.78123.66
547017
44820+2197*1
-4701722.98023.91
647091
45089+2002*1
-4709123.01623.93
60min147390
45120+2270*1
-4739023.16223.301.2524.3124.461.16
248827
46456+2371*1
-4882723.86525.01
347585
45321+2264*1
-4758523.25824.41
447500
45329+2171*1
-4750023.21624.35
547631
45374+2257*1
-4763123.28024.46
647125
44807+2318*1
-4712523.03324.21
极限148462
45933+2529*1
-4846223.68623.481.6625.0924.891.54
248456
46016+2440*1
-4845623.68325.10
348325
45860+2465*1
-4832523.61925.03
447753
45353+2400*1
-4775323.34024.73
546546
44137+2409*1
-4654622.75024.19
648676
46216+2460*1
-4867623.79125.22
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