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%
118.15202045
202045+0
202399
202399+0
201575
201575+0
202715
202715+0
202275
202275+0
2022020.22
218.07202582
202582+0
202986
202986+0
2027840.15
单位质量响应值RSD%判断
11140.6111222.140.52数据可信
供试品溶液-12654484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%
5min168027
64920+3107*1
-6802734.05234.026.9734.0534.026.96
259946
57094+2852*1
-5994630.00730.01
373265
69864+3401*1
-7326536.67436.67
471988
68821+3167*1
-7198836.03436.03
566146
63148+2998*1
-6614633.11033.11
668388
65263+3125*1
-6838834.23234.23
10min1140517
134264+6253*1
-14051770.33769.001.3270.7269.381.32
2138076
131851+6225*1
-13807669.11569.45
3139071
133019+6052*1
-13907169.61370.02
4137399
131411+5988*1
-13739968.77669.18
5136579
130640+5939*1
-13657968.36668.73
6135424
129547+5877*1
-13542467.78868.17
15min1168163
157691+10472*1
-16816384.17683.770.7785.3484.910.77
2166660
156231+10429*1
-16666083.42384.52
3167982
157579+10403*1
-16798284.08585.27
4167505
157300+10205*1
-16750583.84685.01
5168631
158454+10177*1
-16863184.41085.54
6165128
155231+9897*1
-16512882.65783.79
20min1183851
170117+13734*1
-18385192.02891.870.5594.1293.940.55
2183418
169713+13705*1
-18341891.81293.84
3184431
170764+13667*1
-18443192.31994.43
4183001
169727+13274*1
-18300191.60393.70
5184584
171388+13196*1
-18458492.39594.46
6181889
168890+12999*1
-18188991.04693.10
30min1193868
170725+23143*1
-19386897.04396.671.27100.1699.761.24
2191471
168587+22884*1
-19147195.84398.89
3189601
167038+22563*1
-18960194.90798.05
4196273
173284+22989*1
-19627398.246101.36
5195112
172662+22450*1
-19511297.665100.76
6192400
170426+21974*1
-19240096.30899.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1194356
162346+32010*1
-19435697.28798.671.65101.48102.841.58
2197288
164819+32469*1
-19728898.755102.87
3192489
160883+31606*1
-19248996.352100.55
4201540
169047+32493*1
-201540100.883105.09
5198859
167279+31580*1
-19885999.541103.72
6198166
166886+31280*1
-19816699.194103.33
60min1190431
148289+42142*1
-19043195.32296.951.69100.60102.211.62
2191616
149184+42432*1
-19161695.915101.13
3190576
148565+42011*1
-19057695.395100.66
4198245
155038+43207*1
-19824599.234104.56
5195005
153167+41838*1
-19500597.612102.89
6196172
154341+41831*1
-19617298.196103.43
极限1187990
139734+48256*1
-18799094.10096.091.97100.44102.431.88
2187731
139512+48219*1
-18773193.971100.25
3192284
143019+49265*1
-19228496.250102.58
4194613
145419+49194*1
-19461397.416103.84
5197493
148240+49253*1
-19749398.857105.22
6191649
144153+47496*1
-19164995.932102.26
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%
118.15202753
202753+0
203095
203095+0
202045
202045+0
201920
201920+0
202730
202730+0
2025090.25
218.07201026
201026+0
202741
202741+0
2018840.61
单位质量响应值RSD%判断
11157.5211172.330.10数据可信
供试品溶液-12654484批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131086
29212+1874*1
-3108615.58315.7118.9515.5815.7118.94
229388
27729+1659*1
-2938814.73214.73
331707
30002+1705*1
-3170715.89415.89
436501
34436+2065*1
-3650118.29818.30
538056
35561+2495*1
-3805619.07719.08
621316
19620+1696*1
-2131610.68610.69
10min162158
59631+2527*1
-6215831.15931.783.4931.3331.953.55
261443
58993+2450*1
-6144330.80130.96
361822
59372+2450*1
-6182230.99131.17
466294
63702+2592*1
-6629433.23333.44
566123
63548+2575*1
-6612333.14733.36
662518
59839+2679*1
-6251831.34031.46
15min175782
72809+2973*1
-7578237.98938.232.7238.5138.762.76
275122
72277+2845*1
-7512237.65838.16
373431
70529+2902*1
-7343136.81037.33
477904
74861+3043*1
-7790439.05339.63
579289
76203+3086*1
-7928939.74740.33
676055
72928+3127*1
-7605538.12638.59
20min183838
80576+3262*1
-8383842.02742.152.7242.9743.102.75
283934
80743+3191*1
-8393442.07543.00
380536
77397+3139*1
-8053640.37241.30
485989
82597+3392*1
-8598943.10644.11
587047
83592+3455*1
-8704743.63644.66
683127
79785+3342*1
-8312741.67142.56
30min194059
89936+4123*1
-9405947.15146.792.0048.5648.212.06
292218
88124+4094*1
-9221846.22847.62
392187
88206+3981*1
-9218746.21347.59
494711
90466+4245*1
-9471147.47848.96
595915
91598+4317*1
-9591548.08149.59
690959
86805+4154*1
-9095945.59746.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1103575
98304+5271*1
-10357551.92152.382.5253.8554.322.52
2103601
98354+5247*1
-10360151.93453.84
3100133
94936+5197*1
-10013350.19652.09
4106351
100825+5526*1
-10635153.31355.33
5107440
101841+5599*1
-10744053.85955.90
6105840
100329+5511*1
-10584053.05754.92
60min1109762
102897+6865*1
-10976255.02355.361.9557.5357.881.98
2109378
102602+6776*1
-10937854.83057.31
3107174
100347+6827*1
-10717453.72556.18
4113118
105772+7346*1
-11311856.70559.31
5112300
105165+7135*1
-11230056.29558.93
6110849
103852+6997*1
-11084955.56858.02
极限1115716
108063+7653*1
-11571658.00757.832.1161.1360.962.05
2116560
108919+7641*1
-11656058.43061.52
3110557
103086+7471*1
-11055755.42158.47
4116004
107896+8108*1
-11600458.15261.39
5115884
107937+7947*1
-11588458.09261.36
6117412
109587+7825*1
-11741258.85861.92
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%
118.15203202
203202+0
202705
202705+0
202779
202779+0
203004
203004+0
203145
203145+0
2029670.11
218.07202000
202000+0
202516
202516+0
2022580.19
单位质量响应值RSD%判断
11182.7511193.030.07数据可信
供试品溶液-12654484批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12270
1405+865*1
-22701.1361.249.751.141.249.69
22495
1607+888*1
-24951.2481.25
32189
1288+901*1
-21891.0951.10
42447
1518+929*1
-24471.2241.22
52852
1940+912*1
-28521.4271.43
62635
1768+867*1
-26351.3181.32
10min15851
4714+1137*1
-58512.9273.036.532.943.056.50
25741
4630+1111*1
-57412.8722.89
35910
4758+1152*1
-59102.9572.97
45919
4823+1096*1
-59192.9612.97
56124
4940+1184*1
-61243.0643.08
66828
5556+1272*1
-68283.4163.43
15min16665
5463+1202*1
-66653.3343.424.053.383.474.04
26527
5317+1210*1
-65273.2653.31
36787
5586+1201*1
-67873.3953.44
46793
5573+1220*1
-67933.3983.44
57323
6063+1260*1
-73233.6633.71
66967
5625+1342*1
-69673.4853.54
20min16622
5361+1261*1
-66223.3133.383.173.393.463.17
26729
5461+1268*1
-67293.3663.45
36690
5478+1212*1
-66903.3473.43
46683
5469+1214*1
-66833.3433.43
57173
5824+1349*1
-71733.5883.68
66591
5349+1242*1
-65913.2973.39
30min16716
5376+1340*1
-67163.3603.542.613.483.662.60
27099
5736+1363*1
-70993.5513.67
37116
5778+1338*1
-71163.5603.68
47130
5817+1313*1
-71303.5673.69
57241
5692+1549*1
-72413.6223.75
67171
5509+1662*1
-71713.5873.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min17118
5729+1389*1
-71183.5613.571.733.723.731.59
26929
5611+1318*1
-69293.4663.63
37240
5854+1386*1
-72403.6223.78
47262
5905+1357*1
-72623.6333.79
57178
5790+1388*1
-71783.5913.76
67077
5713+1364*1
-70773.5403.71
60min17176
5727+1449*1
-71763.5903.611.763.793.811.63
27117
5735+1382*1
-71173.5603.76
37433
5947+1486*1
-74333.7183.92
47300
5909+1391*1
-73003.6523.85
57144
5753+1391*1
-71443.5743.78
67117
5692+1425*1
-71173.5603.77
极限17464
5977+1487*1
-74643.7343.672.253.973.922.10
27363
5886+1477*1
-73633.6833.92
37276
5826+1450*1
-72763.6403.88
47515
6064+1451*1
-75153.7594.00
57398
5877+1521*1
-73983.7013.95
67052
5634+1418*1
-70523.5283.77
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%
118.15204265
204265+0
202294
202294+0
205268
205268+0
204451
204451+0
203364
203364+0
2039280.56
218.07202000
202000+0
202758
202758+0
2023790.27
单位质量响应值RSD%判断
11235.7011199.720.23数据可信
供试品溶液-12654484批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132343
30937+1406*1
-3234316.13717.373.9816.1417.373.97
235099
33616+1483*1
-3509917.51217.51
334112
32616+1496*1
-3411217.02017.02
435922
34387+1535*1
-3592217.92317.92
535842
34308+1534*1
-3584217.88317.88
635603
34125+1478*1
-3560317.76417.76
10min147847
45977+1870*1
-4784723.87225.012.7624.0525.212.78
250238
48309+1929*1
-5023825.06525.26
349208
47266+1942*1
-4920824.55224.74
450784
48789+1995*1
-5078425.33825.54
551211
49122+2089*1
-5121125.55125.75
651508
49501+2007*1
-5150825.69925.90
15min154904
52760+2144*1
-5490427.39329.042.8927.8429.512.88
259501
57147+2354*1
-5950129.68730.16
358279
55973+2306*1
-5827929.07729.54
459267
56873+2394*1
-5926729.57030.05
558660
56641+2019*1
-5866029.26729.75
658617
56330+2287*1
-5861729.24629.73
20min160851
58388+2463*1
-6085130.36131.552.4231.1132.352.41
263674
61117+2557*1
-6367431.76932.57
364659
62028+2631*1
-6465932.26133.05
464270
61621+2649*1
-6427032.06632.88
561855
59237+2618*1
-6185530.86231.67
664116
61479+2637*1
-6411631.99032.80
30min168188
65295+2893*1
-6818834.02135.892.8935.1137.042.87
274425
70172+4253*1
-7442537.13338.29
372109
69062+3047*1
-7210935.97837.12
471607
68545+3062*1
-7160735.72736.89
572905
69821+3084*1
-7290536.37537.53
672423
69342+3081*1
-7242336.13437.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min174964
71493+3471*1
-7496437.40239.422.6638.8740.962.65
278760
75098+3662*1
-7876039.29640.86
380147
76440+3707*1
-8014739.98841.53
479523
75831+3692*1
-7952339.67741.24
580876
77135+3741*1
-8087640.35241.91
679791
76102+3689*1
-7979139.81041.38
60min180117
75650+4467*1
-8011739.97341.171.7841.8543.151.79
282323
78096+4227*1
-8232341.07443.08
383883
79492+4391*1
-8388341.85243.84
482904
78645+4259*1
-8290441.36443.37
584073
79725+4348*1
-8407341.94743.95
681803
77607+4196*1
-8180340.81442.82
极限185087
80606+4481*1
-8508742.45343.992.2944.7846.432.26
287981
83332+4649*1
-8798143.89746.36
389352
84539+4813*1
-8935244.58147.03
486857
82244+4613*1
-8685743.33645.80
590818
85829+4989*1
-9081845.31247.78
688911
84159+4752*1
-8891144.36146.82
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