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%
1 18.03205943
205943+0
206439
206439+0
206002
206002+0
206405
206405+0
206327
206327+0
2062230.12
2 18.07205493
205493+0
205490
205490+0
2054920.01
单位质量响应值RSD%判断
11437.7711372.000.41数据可信
供试品溶液-2024123121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%
5min176565
73814+2751*1
-7656537.57432.6412.7937.5732.6412.80
275631
73038+2593*1
-7563137.11637.12
367340
65038+2302*1
-6734033.04733.05
465172
62566+2606*1
-6517231.98331.98
556250
54104+2146*1
-5625027.60527.60
658160
56132+2028*1
-5816028.54228.54
10min1139767
134021+5746*1
-13976768.59066.834.4869.0167.194.52
2144018
138118+5900*1
-14401870.67771.09
3138337
132795+5542*1
-13833767.88968.26
4136970
131511+5459*1
-13697067.21867.57
5130156
125007+5149*1
-13015663.87464.18
6127803
122783+5020*1
-12780362.71963.04
15min1162989
152801+10188*1
-16298979.98681.281.9481.1782.391.97
2170363
159750+10613*1
-17036383.60584.80
3168008
157966+10042*1
-16800882.45083.57
4166581
156745+9836*1
-16658181.74982.85
5162289
152639+9650*1
-16228979.64380.66
6163529
154165+9364*1
-16352980.25181.27
20min1176010
162548+13462*1
-17601086.37788.351.6888.4490.361.69
2182324
168399+13925*1
-18232489.47591.60
3182907
169535+13372*1
-18290789.76191.80
4182735
169418+13317*1
-18273589.67791.69
5177385
164717+12668*1
-17738587.05188.95
6178816
166260+12556*1
-17881687.75489.66
30min1183058
162131+20927*1
-18305889.83594.392.5392.8697.382.45
2193851
171794+22057*1
-19385195.13298.25
3196502
174994+21508*1
-19650296.43399.47
4194421
173232+21189*1
-19442195.41298.42
5194939
174422+20517*1
-19493995.66698.53
6191305
171117+20188*1
-19130593.88396.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1185529
151418+34111*1
-18552991.04894.942.1395.0798.982.04
2195208
159492+35716*1
-19520895.79899.98
3194038
159569+34469*1
-19403895.22499.33
4194073
159684+34389*1
-19407395.24199.31
5197640
162958+34682*1
-19764096.991100.92
6194291
160586+33705*1
-19429195.34899.27
60min1184351
141410+42941*1
-18435190.47094.612.3895.5199.702.25
2191012
146760+44252*1
-19101293.73998.98
3194148
149945+44203*1
-19414895.278100.44
4196140
151888+44252*1
-19614096.255101.38
5194571
151454+43117*1
-19457195.485100.49
6196512
152889+43623*1
-19651296.438101.42
极限1181474
132708+48766*1
-18147489.05893.892.6595.10100.042.52
2190497
139415+51082*1
-19049793.48699.77
3194443
143737+50706*1
-19444395.422101.65
4193453
143056+50397*1
-19345394.937101.13
5194860
145325+49535*1
-19486095.627101.70
6193175
143801+49374*1
-19317594.800100.86
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%
1 18.03205234
205234+0
206028
206028+0
206013
206013+0
205471
205471+0
206013
206013+0
2057520.19
2 18.07205258
205258+0
205607
205607+0
2054320.13
单位质量响应值RSD%判断
11411.6511368.680.27数据可信
供试品溶液-2024123121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118791
17771+1020*1
-187919.23410.708.149.2310.708.15
223011
21898+1113*1
-2301111.30711.31
323872
22610+1262*1
-2387211.73011.73
421841
20755+1086*1
-2184110.73210.73
520938
19861+1077*1
-2093810.28910.29
622140
20941+1199*1
-2214010.87910.88
10min148943
46693+2250*1
-4894324.05025.663.6024.1525.783.62
253179
51233+1946*1
-5317926.13126.26
352383
50433+1950*1
-5238325.74025.87
453015
51029+1986*1
-5301526.05026.17
551459
49448+2011*1
-5145925.28625.40
654396
52350+2046*1
-5439626.72926.85
15min163061
60730+2331*1
-6306130.98733.333.7431.3633.733.74
268214
65861+2353*1
-6821433.51933.93
368431
65979+2452*1
-6843133.62634.04
470650
68114+2536*1
-7065034.71635.12
567793
65388+2405*1
-6779333.31233.71
668772
66365+2407*1
-6877233.79334.21
20min176198
73351+2847*1
-7619837.44239.574.3038.1640.354.26
282026
76750+5276*1
-8202640.30641.09
386119
75130+10989*1
-8611942.31743.11
480654
77787+2867*1
-8065439.63240.43
580410
76637+3773*1
-8041039.51240.28
677784
75118+2666*1
-7778438.22139.01
30min183702
79792+3910*1
-8370241.12942.892.7742.2644.102.75
287161
83411+3750*1
-8716142.82944.07
385881
82022+3859*1
-8588142.20043.46
490896
86882+4014*1
-9089644.66445.90
587706
83861+3845*1
-8770643.09744.30
688322
84518+3804*1
-8832243.40044.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min185420
80987+4433*1
-8542041.97447.786.7243.5649.476.59
297907
92888+5019*1
-9790748.11049.82
396634
91605+5029*1
-9663447.48449.21
4105335
100006+5329*1
-10533551.75953.49
599518
94509+5009*1
-9951848.90150.58
698638
93760+4878*1
-9863848.46950.17
60min199980
93511+6469*1
-9998049.12851.605.0751.1853.824.95
2102822
96134+6688*1
-10282250.52552.77
3114760
95186+19574*1
-11476056.39158.65
4106927
99955+6972*1
-10692752.54254.85
5101647
95183+6464*1
-10164749.94752.17
6103916
97420+6496*1
-10391651.06253.30
极限1108992
101552+7440*1
-10899253.55654.342.1556.1657.142.14
2110246
102866+7380*1
-11024654.17356.98
3109612
99906+9706*1
-10961253.86156.74
4115073
107102+7971*1
-11507356.54559.43
5111084
103688+7396*1
-11108454.58457.37
6108523
101306+7217*1
-10852353.32656.13
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