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D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23203557
203557+0		203577
203577+0		203474
203474+0		203367
203367+0		203107
203107+0		2034160.10
219.28203396
203396+0		202435
202435+0		2029160.34
单位质量响应值RSD%判断
10578.0610524.690.36数据可信
长期12月-供试品溶液-12343797批-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%
5min167000.8
63612+4236*0.8		-67000.833.27532.495.2233.2732.495.22
264738.2
61115+4529*0.8		-64738.232.15132.15
363385
59785+4500*0.8		-6338531.47931.48
464618.6
61361+4072*0.8		-64618.632.09232.09
571315.6
67474+4802*0.8		-71315.635.41835.42
661458.2
58171+4109*0.8		-61458.230.52230.52
10min1129469
122781+8360*0.8		-12946964.29865.011.1564.6765.371.14
2129515.2
122424+8864*0.8		-129515.264.32164.68
3129876.4
122638+9048*0.8		-129876.464.50164.85
4133090.2
126179+8639*0.8		-133090.266.09766.45
5131642.2
124527+8894*0.8		-131642.265.37865.77
6131790.4
124444+9183*0.8		-131790.465.45165.79
15min1159955
150823+11415*0.8		-15995579.43980.061.5380.5281.151.53
2157973.8
148513+11826*0.8		-157973.878.45579.53
3159950.8
150218+12166*0.8		-159950.879.43780.50
4162470.8
153102+11711*0.8		-162470.880.68881.78
5164992
154304+13360*0.8		-16499281.94083.06
6161951.6
152062+12362*0.8		-161951.680.43081.50
20min1169199.8
153139+20076*0.8		-169199.884.03084.911.1286.0086.881.11
2168988.2
152497+20614*0.8		-168988.283.92585.87
3170439.2
153648+20989*0.8		-170439.284.64686.59
4170903
154471+20540*0.8		-17090384.87686.86
5172422
155546+21095*0.8		-17242285.63087.66
6173914.8
156846+21336*0.8		-173914.886.37288.33
30min1186503.4
165093+26763*0.8		-186503.492.62492.340.7495.5295.260.72
2185235
163311+27405*0.8		-18523591.99494.87
3186251.8
164119+27666*0.8		-186251.892.49995.39
4187277.8
165601+27096*0.8		-187277.893.00895.94
5186782.2
164771+27514*0.8		-186782.292.76295.74
6183529.4
161871+27073*0.8		-183529.491.14794.07
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1178159.8
145835+40406*0.8		-178159.888.48090.351.7492.4194.291.68
2182535.4
148925+42013*0.8		-182535.490.65394.55
3185666.6
151297+42962*0.8		-185666.692.20896.13
4183868.6
150191+42097*0.8		-183868.691.31595.28
5183323.6
149682+42052*0.8		-183323.691.04495.06
6177976.6
144075+42377*0.8		-177976.688.38992.32
60min1179624.4
140414+49013*0.8		-179624.489.20790.231.1194.1295.171.07
2182567
141959+50760*0.8		-18256790.66995.57
3184579.2
143364+51519*0.8		-184579.291.66896.61
4179664.8
140024+49551*0.8		-179664.889.22794.21
5182991.8
142411+50726*0.8		-182991.890.88095.90
6180623.8
140475+50186*0.8		-180623.889.70494.62
极限1176970.6
133909+53827*0.8		-176970.687.88989.211.3793.7995.151.31
2182582
137654+56160*0.8		-18258290.67696.59
3180789
136397+55490*0.8		-18078989.78695.75
4179679.8
135843+54796*0.8		-179679.889.23595.20
5181256.8
136872+55481*0.8		-181256.890.01896.05
6176442.4
133316+53908*0.8		-176442.487.62793.54
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D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23203646
203646+0		203761
203761+0		203554
203554+0		203657
203657+0		203780
203780+0		2036800.05
219.28207783
207783+0		208044
208044+0		2079140.09
单位质量响应值RSD%判断
10591.7810783.921.28数据可信
长期12月-供试品溶液-12343797批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min161491.4
57661+4788*0.8		-61491.430.15132.314.2430.1532.314.24
268099.6
64094+5007*0.8		-68099.633.39133.39
364478.6
60489+4987*0.8		-64478.631.61631.62
467232.8
62772+5576*0.8		-67232.832.96632.97
569070.2
65071+4999*0.8		-69070.233.86733.87
664995.6
61194+4752*0.8		-64995.631.86931.87
10min1125357.6
117868+9362*0.8		-125357.661.46663.202.2361.8063.562.23
2129194
121598+9495*0.8		-12919463.34763.72
3127948.2
120077+9839*0.8		-127948.262.73663.09
4133594.6
125393+10252*0.8		-133594.665.50565.87
5130259.4
122889+9213*0.8		-130259.463.87064.25
6126993.8
119601+9241*0.8		-126993.862.26862.62
15min1154865.8
144985+12351*0.8		-154865.875.93577.821.6376.9578.881.64
2159527.6
149190+12922*0.8		-159527.678.22179.30
3159443.6
148870+13217*0.8		-159443.678.18079.23
4162395.8
151555+13551*0.8		-162395.879.62780.72
5159227.2
149272+12444*0.8		-159227.278.07379.16
6156836
146620+12770*0.8		-15683676.90177.95
20min1168613
152013+20750*0.8		-16861382.67684.182.0984.5486.102.07
2175612.2
157753+22324*0.8		-175612.286.10788.05
3169990.6
152529+21827*0.8		-169990.683.35185.27
4170229.6
152856+21717*0.8		-170229.683.46885.45
5176795.2
159344+21814*0.8		-176795.286.68788.64
6168793.2
152026+20959*0.8		-168793.282.76484.66
30min1186221.4
164611+27013*0.8		-186221.491.30991.281.0694.0994.141.04
2189970
166866+28880*0.8		-18997093.14796.05
3185695.6
162866+28537*0.8		-185695.691.05293.89
4185712.4
162974+28423*0.8		-185712.491.06093.97
5184362.4
162464+27373*0.8		-184362.490.39893.31
6185060.4
163034+27533*0.8		-185060.490.74093.56
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1176587.6
144898+39612*0.8		-176587.686.58689.192.3890.3893.062.31
2183739.4
149165+43218*0.8		-183739.490.09294.03
3187548
152216+44165*0.8		-18754891.96095.81
4178151
144743+41760*0.8		-17815187.35291.27
5185374.6
151129+42807*0.8		-185374.690.89494.82
6179950
145906+42555*0.8		-17995088.23492.06
60min1185165.2
145194+49964*0.8		-185165.290.79287.851.9095.5592.721.77
2178789.2
138510+50349*0.8		-178789.287.66592.60
3179293.8
138729+50706*0.8		-179293.887.91392.79
4178821.8
138533+50361*0.8		-178821.887.68192.57
5178290.6
138505+49732*0.8		-178290.687.42192.35
6174644.4
135826+48523*0.8		-174644.485.63390.44
极限1181976.6
138559+54272*0.8		-181976.689.22888.431.8294.9994.281.73
2183876
137996+57350*0.8		-18387690.15996.07
3183373.4
137447+57408*0.8		-183373.489.91395.77
4176978.6
132789+55237*0.8		-176978.686.77792.64
5179773.8
135401+55466*0.8		-179773.888.14894.05
6176158
132910+54060*0.8		-17615886.37592.14
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