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%
119.23203720
203720+0
203821
203821+0
203922
203922+0
203852
203852+0
203793
203793+0
2038220.04
219.28203425
203425+0
203337
203337+0
2033810.04
单位质量响应值RSD%判断
10599.1710548.810.34数据可信
中间条件12月-供试品溶液-2023082421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%
5min189299.6
83814+6857*0.8
-89299.644.25444.265.5944.2544.265.59
287305.2
81802+6879*0.8
-87305.243.26643.27
392947.4
87061+7358*0.8
-92947.446.06246.06
491480
85724+7195*0.8
-9148045.33545.33
580515.6
75238+6597*0.8
-80515.639.90139.90
694321
88309+7515*0.8
-9432146.74346.74
10min1140158
131302+11070*0.8
-14015869.45870.132.5969.9570.622.61
2140870.8
131714+11446*0.8
-140870.869.81170.29
3143585.6
134260+11657*0.8
-143585.671.15771.67
4141503.4
132289+11518*0.8
-141503.470.12570.63
5135987.4
126981+11258*0.8
-135987.467.39167.83
6146989.2
137466+11904*0.8
-146989.272.84373.36
15min1165375
153651+14655*0.8
-16537581.95582.022.4083.2283.302.42
2163084.2
151165+14899*0.8
-163084.280.82082.08
3167177
155013+15205*0.8
-16717782.84884.15
4166513
154417+15120*0.8
-16651382.51983.80
5159608.4
147866+14678*0.8
-159608.479.09780.29
6171331
158975+15445*0.8
-17133184.90686.24
20min1177443.4
163153+17863*0.8
-177443.487.93688.311.3890.1190.501.38
2176225.2
161666+18199*0.8
-176225.287.33289.49
3176832.8
162280+18191*0.8
-176832.887.63389.86
4176871.4
162309+18203*0.8
-176871.487.65289.85
5179035.6
164406+18287*0.8
-179035.688.72590.80
6182810
167958+18565*0.8
-18281090.59592.87
30min1182069.2
158786+29104*0.8
-182069.290.22892.452.0093.3895.611.99
2184969
160733+30295*0.8
-18496991.66594.79
3187052.4
162962+30113*0.8
-187052.492.69895.89
4186025.4
161935+30113*0.8
-186025.492.18995.36
5185834
162358+29345*0.8
-18583492.09495.15
6193322.4
168744+30723*0.8
-193322.495.80599.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1172981.4
143283+37123*0.8
-172981.485.72491.954.4189.8896.144.26
2179165.4
148239+38658*0.8
-179165.488.78992.93
3186825.4
155851+38718*0.8
-186825.492.58596.81
4187002.4
155748+39068*0.8
-187002.492.67396.87
5192842.2
161823+38774*0.8
-192842.295.56799.65
6194424.8
162664+39701*0.8
-194424.896.351100.69
60min1181085.6
139900+51482*0.8
-181085.689.74191.711.8094.8596.921.79
2182711.6
141394+51647*0.8
-182711.690.54695.68
3184615.2
142632+52479*0.8
-184615.291.49096.75
4183976.6
142039+52422*0.8
-183976.691.17396.40
5187913.2
146022+52364*0.8
-187913.293.12498.27
6190016.2
147405+53264*0.8
-190016.294.16699.58
极限1180763.4
135701+56328*0.8
-180763.489.58190.641.7595.6896.871.66
2183411.4
137401+57513*0.8
-183411.490.89397.03
3181295
135775+56900*0.8
-18129589.84496.12
4179039.4
134461+55723*0.8
-179039.488.72794.97
5187776.8
141528+57811*0.8
-187776.893.05799.23
6185062.6
139249+57267*0.8
-185062.691.71198.17
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%
119.23203433
203433+0
203489
203489+0
203082
203082+0
203129
203129+0
203190
203190+0
2032650.10
219.28202725
202725+0
202624
202624+0
2026740.04
单位质量响应值RSD%判断
10570.2010512.140.39数据可信
中间条件12月-供试品溶液-2023082421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192291.6
86106+7732*0.8
-92291.645.87946.512.0945.8846.512.09
295998.2
89527+8089*0.8
-95998.247.72247.72
393500.8
87160+7926*0.8
-93500.846.48146.48
494836.8
88480+7946*0.8
-94836.847.14547.14
590495
84415+7600*0.8
-9049544.98644.99
694284.6
88039+7807*0.8
-94284.646.87046.87
10min1144171.4
134193+12473*0.8
-144171.471.67071.791.5172.1872.311.51
2143279
133095+12730*0.8
-14327971.22671.76
3143630.8
133554+12596*0.8
-143630.871.40171.92
4148367.4
138025+12928*0.8
-148367.473.75574.28
5142040.4
132122+12398*0.8
-142040.470.61071.11
6145037.6
135032+12507*0.8
-145037.672.10072.62
15min1164923.6
152302+15777*0.8
-164923.681.98683.381.3283.2984.691.31
2169230.4
155868+16703*0.8
-169230.484.12785.45
3164844.2
152101+15929*0.8
-164844.281.94683.26
4169258.4
156072+16483*0.8
-169258.484.14185.48
5168918.2
155775+16429*0.8
-168918.283.97285.26
6169175.8
156119+16321*0.8
-169175.884.10085.42
20min1180542.6
164941+19502*0.8
-180542.689.75089.570.8391.9791.810.82
2181953.8
165897+20071*0.8
-181953.890.45292.71
3177549.2
162022+19409*0.8
-177549.288.26290.48
4179883.6
164146+19672*0.8
-179883.689.42391.70
5180113.4
164331+19728*0.8
-180113.489.53791.75
6181059.4
165377+19603*0.8
-181059.490.00792.26
30min1186462.4
162168+30368*0.8
-186462.492.69392.001.6695.9195.241.61
2186738.4
162008+30913*0.8
-186738.492.83096.09
3187824
163488+30420*0.8
-18782493.37096.57
4186647.2
162284+30454*0.8
-186647.292.78596.06
5179818.8
156710+28886*0.8
-179818.889.39092.60
6182979.4
159641+29173*0.8
-182979.490.96294.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1178615.8
147519+38871*0.8
-178615.888.79293.193.0893.0497.452.94
2191424.4
159390+40043*0.8
-191424.495.16099.45
3182717
152525+37740*0.8
-18271790.83195.07
4188177.8
156885+39116*0.8
-188177.893.54697.85
5194046
162278+39710*0.8
-19404696.463100.67
6189813.2
158578+39044*0.8
-189813.294.35998.63
60min1181855.2
140184+52089*0.8
-181855.290.40391.241.0295.6396.540.99
2184344.4
142158+52733*0.8
-184344.491.64096.99
3182832
141276+51945*0.8
-18283290.88896.14
4185076.2
143001+52594*0.8
-185076.292.00497.35
5185912.8
144152+52201*0.8
-185912.892.42097.70
6181220.2
140381+51049*0.8
-181220.290.08795.40
极限1185701.2
139194+58134*0.8
-185701.292.31591.930.6698.5598.240.58
2183513.6
137116+57997*0.8
-183513.691.22797.60
3186813.2
139578+59044*0.8
-186813.292.86799.12
4185008.6
138367+58302*0.8
-185008.691.97098.33
5183830
138026+57255*0.8
-18383091.38497.69
6184678.6
138917+57202*0.8
-184678.691.80698.12
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%
119.23203672
203672+0
203418
203418+0
203253
203253+0
203177
203177+0
203211
203211+0
2033460.11
219.28204536
204536+0
204480
204480+0
2045080.02
单位质量响应值RSD%判断
10574.4110607.260.22数据可信
中间条件12月-供试品溶液-2023082521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191656.2
85957+7124*0.8
-91656.245.35044.182.0545.3544.182.05
290976.4
85142+7293*0.8
-90976.445.01345.01
388024.6
82695+6662*0.8
-88024.643.55343.55
487723.2
82068+7069*0.8
-87723.243.40443.40
587379.2
81884+6869*0.8
-87379.243.23343.23
689988.8
83724+7831*0.8
-89988.844.52544.52
10min1139967.6
130930+11297*0.8
-139967.669.25367.652.5269.7668.142.51
2136007
126931+11345*0.8
-13600767.29467.79
3133955.8
125371+10731*0.8
-133955.866.27966.76
4139574.8
130354+11526*0.8
-139574.869.05969.54
5131620.4
123130+10613*0.8
-131620.465.12365.60
6139196
129900+11620*0.8
-13919668.87169.37
15min1163072.8
151252+14776*0.8
-163072.880.68579.702.3581.9680.942.34
2161565.8
149673+14866*0.8
-161565.879.93981.19
3163859.2
152228+14539*0.8
-163859.281.07482.29
4161842.8
150130+14641*0.8
-161842.880.07781.33
5153562.2
142607+13694*0.8
-153562.275.97977.18
6162574
150818+14695*0.8
-16257480.43881.70
20min1174570
160162+18010*0.8
-17457086.37486.562.4988.5488.692.46
2175193.2
160862+17914*0.8
-175193.286.68288.82
3174074.6
160113+17452*0.8
-174074.686.12988.25
4174630.2
160627+17504*0.8
-174630.286.40388.54
5168820.6
155539+16602*0.8
-168820.683.52985.58
6182405.6
167772+18292*0.8
-182405.690.25192.40
30min1179551
157139+28015*0.8
-17955188.83890.691.8491.9793.781.80
2180830.4
158764+27583*0.8
-180830.489.47192.57
3183752
161620+27665*0.8
-18375290.91793.99
4183749.4
161735+27518*0.8
-183749.490.91594.01
5182602.8
161022+26976*0.8
-182602.890.34893.32
6189279.6
166602+28347*0.8
-189279.693.65296.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1187970.8
157614+37946*0.8
-187970.893.00493.651.6997.1297.751.67
2189915.2
160172+37179*0.8
-189915.293.96698.06
3185107.4
156453+35818*0.8
-185107.491.58795.68
4190613.6
161112+36877*0.8
-190613.694.31298.42
5187579
159159+35525*0.8
-18757992.81096.79
6194452.6
164599+37317*0.8
-194452.696.211100.41
60min1179425
139709+49645*0.8
-17942588.77690.291.1693.9395.431.12
2181210.4
142344+48583*0.8
-181210.489.65994.80
3182985.4
144103+48603*0.8
-182985.490.53795.64
4185384.4
146122+49078*0.8
-185384.491.72496.88
5181945.2
144406+46924*0.8
-181945.290.02395.03
6183972.2
145533+48049*0.8
-183972.291.02696.29
极限1181844.8
137136+55886*0.8
-181844.889.97390.871.7196.1197.011.66
2185904.4
141766+55173*0.8
-185904.491.98298.12
3178874.4
136612+52828*0.8
-178874.488.50394.62
4185153.6
141568+54482*0.8
-185153.691.61097.79
5182659
140275+52980*0.8
-18265990.37696.39
6187483
143779+54630*0.8
-18748392.76399.04
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%
119.23203256
203256+0
203346
203346+0
203323
203323+0
203329
203329+0
203491
203491+0
2033490.05
219.28202015
202015+0
201817
201817+0
2019160.07
单位质量响应值RSD%判断
10574.5710472.820.69数据可信
中间条件12月-供试品溶液-2023082521批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187645.4
81791+7318*0.8
-87645.443.64343.831.4343.6443.831.43
288497.8
82653+7306*0.8
-88497.844.06744.07
388603.2
82856+7184*0.8
-88603.244.12044.12
485970
80206+7205*0.8
-8597042.80842.81
589708.4
83614+7618*0.8
-89708.444.67044.67
687680
81664+7520*0.8
-8768043.66043.66
10min1133028.6
124015+11267*0.8
-133028.666.24167.672.5266.7368.162.50
2139948.2
130325+12029*0.8
-139948.269.68770.18
3137935.8
128307+12036*0.8
-137935.868.68569.17
4136604.6
127023+11977*0.8
-136604.668.02268.50
5137165.8
127717+11811*0.8
-137165.868.30168.80
6130664.2
121593+11339*0.8
-130664.265.06465.55
15min1157931
143183+18435*0.8
-15793178.64178.171.1879.8679.401.18
2158032.2
143345+18359*0.8
-158032.278.69279.96
3157206
142370+18545*0.8
-15720678.28079.53
4156983
142475+18135*0.8
-15698378.16979.40
5158335.8
143583+18441*0.8
-158335.878.84380.10
6153367.8
139311+17571*0.8
-153367.876.36977.58
20min1173203.2
155932+21589*0.8
-173203.286.24684.852.3788.3486.962.33
2176345
161733+18265*0.8
-17634587.81089.95
3169727.2
155636+17614*0.8
-169727.284.51586.64
4170944.4
156722+17778*0.8
-170944.485.12187.22
5165526.4
151648+17348*0.8
-165526.482.42384.55
6166713.4
152799+17393*0.8
-166713.483.01485.07
30min1179075.2
157516+26949*0.8
-179075.289.17090.961.6192.2294.011.56
2185639.8
162999+28301*0.8
-185639.892.43995.55
3185034.8
162674+27951*0.8
-185034.892.13895.20
4179159
157499+27075*0.8
-17915989.21292.26
5182653.4
160447+27758*0.8
-182653.490.95294.00
6184416.4
162318+27623*0.8
-184416.491.83094.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1188363.2
159376+36234*0.8
-188363.293.79594.130.3197.8498.190.30
2189105.4
159375+37163*0.8
-189105.494.16498.31
3189602.4
159948+37068*0.8
-189602.494.41298.50
4188745.8
159521+36531*0.8
-188745.893.98598.02
5188580
159252+36660*0.8
-18858093.90397.96
6189817.4
160587+36538*0.8
-189817.494.51998.52
60min1178827
141111+47145*0.8
-17882789.04691.961.6794.1397.061.59
2184683
145219+49330*0.8
-18468391.96297.15
3187414.4
147452+49953*0.8
-187414.493.32298.46
4186858.6
147465+49242*0.8
-186858.693.04698.13
5185559.2
146288+49089*0.8
-185559.292.39997.50
6184694.2
146083+48264*0.8
-184694.291.96897.02
极限1187008
143172+54795*0.8
-18700893.12092.111.6799.2098.251.55
2187167.6
142742+55532*0.8
-187167.693.20099.41
3179746.8
137226+53151*0.8
-179746.889.50495.68
4187231.8
143439+54741*0.8
-187231.893.23199.35
5182747
140231+53145*0.8
-18274790.99897.13
6186033.2
142746+54109*0.8
-186033.292.63598.71
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