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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23205813
205813+0
206149
206149+0
205804
205804+0
205964
205964+0
205990
205990+0
2059440.07
219.28205829
205829+0
205892
205892+0
2058600.03
单位质量响应值RSD%判断
10709.5210677.390.22数据可信
长期12月-供试品溶液-2023082021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%
5min1105851.6
99738+7642*0.8
-105851.651.87151.624.2451.8751.624.24
2105767.2
99652+7644*0.8
-105767.251.82951.83
3106915.8
100767+7686*0.8
-106915.852.39252.39
4110374.4
103976+7998*0.8
-110374.454.08754.09
5106132.8
99956+7721*0.8
-106132.852.00852.01
696943.6
91018+7407*0.8
-96943.647.50547.51
10min1163457.6
153668+12237*0.8
-163457.680.09978.392.8180.6878.962.81
2160643.2
151012+12039*0.8
-160643.278.72079.30
3159752.2
150133+12024*0.8
-159752.278.28478.87
4161392
151684+12135*0.8
-16139279.08779.69
5163230.2
153271+12449*0.8
-163230.279.98880.57
6151306.8
142142+11456*0.8
-151306.874.14574.67
15min1181957.2
169474+15604*0.8
-181957.289.16588.442.3590.6389.892.36
2178733.4
166383+15438*0.8
-178733.487.58589.04
3179924.2
167321+15754*0.8
-179924.288.16989.62
4184331
171567+15955*0.8
-18433190.32891.81
5184662.8
171850+16016*0.8
-184662.890.49191.96
6173280.6
161311+14962*0.8
-173280.684.91386.26
20min1185105.8
169029+20096*0.8
-185105.890.70890.311.6593.1692.741.67
2183423
167487+19920*0.8
-18342389.88392.31
3184505.6
168344+20202*0.8
-184505.690.41492.85
4184451
168439+20015*0.8
-18445190.38792.87
5188862
172518+20430*0.8
-18886292.54895.02
6179446.4
164116+19163*0.8
-179446.487.93490.23
30min1186134.6
159077+33822*0.8
-186134.691.21289.773.2994.6893.203.18
2185236.6
158215+33777*0.8
-185236.690.77294.19
3170989.2
145858+31414*0.8
-170989.283.79087.23
4185433.4
158611+33528*0.8
-185433.490.86894.36
5186817.4
159827+33738*0.8
-186817.491.54695.05
6184488.8
158304+32731*0.8
-184488.890.40593.68
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1185587.8
151451+42671*0.8
-185587.890.94489.611.5095.4294.041.48
2180602
147170+41790*0.8
-18060288.50192.93
3178637.4
145435+41503*0.8
-178637.487.53891.91
4184148.4
150394+42193*0.8
-184148.490.23994.74
5185147.4
151105+42553*0.8
-185147.490.72895.25
6183112.4
149978+41418*0.8
-183112.489.73194.01
60min1178617.6
134844+54717*0.8
-178617.687.52887.640.9293.0293.070.96
2178120.4
134602+54398*0.8
-178120.487.28592.70
3178777.8
135109+54586*0.8
-178777.887.60792.95
4179816.8
136324+54366*0.8
-179816.888.11693.62
5181324.2
137433+54864*0.8
-181324.288.85594.38
6176457.2
134074+52979*0.8
-176457.286.47091.74
极限1183139.2
134636+60629*0.8
-183139.289.74488.810.7896.2195.210.80
2179632
131984+59560*0.8
-17963288.02594.41
3180643
133083+59450*0.8
-18064388.52194.83
4180705.4
133219+59358*0.8
-180705.488.55195.03
5182811.2
134812+59999*0.8
-182811.289.58396.10
6180526
133386+58925*0.8
-18052688.46394.70
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23205787
205787+0
205551
205551+0
205378
205378+0
205230
205230+0
205238
205238+0
2054370.12
219.28206714
206714+0
206576
206576+0
2066450.05
单位质量响应值RSD%判断
10683.1510718.100.24数据可信
长期12月-供试品溶液-2023082021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198507
91639+8585*0.8
-9850748.23947.883.1848.2447.883.17
298456.4
91586+8588*0.8
-98456.448.21448.21
3100633.6
93636+8747*0.8
-100633.649.28149.28
496469.8
89701+8461*0.8
-96469.847.24247.24
592252
85696+8195*0.8
-9225245.17645.18
6100374
93410+8705*0.8
-10037449.15349.15
10min1150561.2
139334+14034*0.8
-150561.273.73073.842.0174.2774.372.01
2152828
141316+14390*0.8
-15282874.84075.38
3155054.2
143379+14594*0.8
-155054.275.93176.48
4146410.2
135359+13814*0.8
-146410.271.69872.22
5148788.8
137624+13956*0.8
-148788.872.86273.36
6151057.2
139794+14079*0.8
-151057.273.97374.52
15min1168885.6
154812+17592*0.8
-168885.682.70483.791.5984.0685.141.60
2172026.2
155687+20424*0.8
-172026.284.24285.61
3175735
160883+18565*0.8
-17573586.05887.45
4170619.2
156296+17904*0.8
-170619.283.55384.87
5168030
153870+17700*0.8
-16803082.28583.60
6171277
156993+17855*0.8
-17127783.87585.24
20min1183778.8
166786+21241*0.8
-183778.889.99788.751.4792.2791.031.46
2181601
164685+21145*0.8
-18160188.93191.23
3184943.4
167525+21773*0.8
-184943.490.56792.91
4178887
162243+20805*0.8
-17888787.60289.85
5179005.8
162505+20626*0.8
-179005.887.66089.89
6179147.8
162579+20711*0.8
-179147.887.72990.03
30min1186465.2
159762+33379*0.8
-186465.291.31390.231.4094.5993.501.39
2186281
159885+32995*0.8
-18628191.22294.51
3186297
159513+33480*0.8
-18629791.23094.58
4180882.6
154893+32487*0.8
-180882.688.57991.80
5184253.8
158217+32546*0.8
-184253.890.23093.43
6181306.2
155699+32009*0.8
-181306.288.78692.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1187514.6
153949+41957*0.8
-187514.691.82789.941.4996.1294.211.47
2184264.2
151089+41469*0.8
-184264.290.23594.54
3184894.8
151150+42181*0.8
-184894.890.54494.91
4179228.2
146841+40484*0.8
-179228.287.76991.98
5183167.8
150427+40926*0.8
-183167.889.69893.90
6182911.8
150019+41116*0.8
-182911.889.57393.83
60min1181694.4
142716+48723*0.8
-181694.488.97688.450.7094.2993.720.69
2180183.8
141351+48541*0.8
-180183.888.23793.54
3180653.2
141422+49039*0.8
-180653.288.46693.84
4178357.8
140097+47826*0.8
-178357.887.34292.53
5181558.2
142755+48504*0.8
-181558.288.91094.11
6181282.8
142294+48736*0.8
-181282.888.77594.03
极限1179704.8
136200+54381*0.8
-179704.888.00287.931.7694.3094.181.59
2175265
132853+53015*0.8
-17526585.82892.12
3178221.2
134938+54104*0.8
-178221.287.27693.63
4183713
140145+54460*0.8
-18371389.96596.12
5182604.2
139217+54234*0.8
-182604.289.42295.61
6177840.8
134932+53636*0.8
-177840.887.08993.33
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23207004
207004+0
206754
206754+0
206103
206103+0
205802
205802+0
205471
205471+0
2062270.32
219.28205721
205721+0
206485
206485+0
2061030.27
单位质量响应值RSD%判断
10724.2310689.990.23数据可信
长期12月-供试品溶液-2023082121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100323.8
93791+8166*0.8
-100323.849.09944.226.7849.1044.226.78
286713.6
81000+7142*0.8
-86713.642.43842.44
395175.8
88843+7916*0.8
-95175.846.58046.58
487453.6
81796+7072*0.8
-87453.642.80042.80
588424.8
82700+7156*0.8
-88424.843.27643.28
684076
78328+7185*0.8
-8407641.14741.15
10min1157088.2
146501+13234*0.8
-157088.276.88073.532.4977.4374.022.52
2149261
139185+12595*0.8
-14926173.04973.52
3151741.4
141507+12793*0.8
-151741.474.26374.78
4147721
137833+12360*0.8
-14772172.29672.77
5148706.4
138772+12418*0.8
-148706.472.77873.26
6146926.4
136784+12678*0.8
-146926.471.90772.36
15min1179398.2
165967+16789*0.8
-179398.287.79986.221.8089.2087.531.82
2175979.6
162766+16517*0.8
-175979.686.12687.41
3177536.4
164194+16678*0.8
-177536.486.88888.23
4173340.4
160478+16078*0.8
-173340.484.83486.11
5179146.8
165934+16516*0.8
-179146.887.67688.97
6171632.6
158583+16312*0.8
-171632.683.99885.25
20min1193150
175306+22305*0.8
-19315094.52991.842.2896.9094.112.29
2188464.2
172669+19744*0.8
-188464.292.23694.48
3188141.2
172306+19794*0.8
-188141.292.07894.39
4183576.8
168260+19146*0.8
-183576.889.84492.07
5190791.4
175013+19723*0.8
-190791.493.37595.64
6181850.2
166439+19264*0.8
-181850.288.99991.19
30min1190083.2
161900+35229*0.8
-190083.293.02892.621.3796.4595.911.38
2191878
163626+35315*0.8
-19187893.90697.17
3190862
162838+35030*0.8
-19086293.40996.74
4187145
159745+34250*0.8
-18714591.59094.81
5190458.6
162773+34607*0.8
-190458.693.21296.51
6185098
157738+34200*0.8
-18509890.58893.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1189991.2
154228+44704*0.8
-189991.292.98393.591.3997.4497.901.35
2190143.4
154521+44528*0.8
-190143.493.05797.37
3196437.6
159648+45987*0.8
-196437.696.138100.51
4189026.2
154043+43729*0.8
-189026.292.51196.75
5190690.8
155354+44171*0.8
-190690.893.32597.66
6191053.6
155640+44267*0.8
-191053.693.50397.69
60min1186692.8
144740+52441*0.8
-186692.891.36991.690.8996.8697.050.86
2186843.2
144980+52329*0.8
-186843.291.44296.78
3189191.2
146772+53024*0.8
-189191.292.59198.03
4184852.2
144209+50804*0.8
-184852.290.46895.73
5187357.2
145754+52004*0.8
-187357.291.69497.07
6189214.6
146985+52787*0.8
-189214.692.60397.83
极限1187321.2
138610+60889*0.8
-187321.291.67692.010.7198.1898.390.65
2189129
140685+60555*0.8
-18912992.56198.92
3187297
139393+59880*0.8
-18729791.66498.13
4186076.2
139177+58624*0.8
-186076.291.06797.34
5188720.6
140923+59747*0.8
-188720.692.36198.75
6189505.8
141417+60111*0.8
-189505.892.74599.00
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.23206290
206290+0
206499
206499+0
206458
206458+0
206289
206289+0
206198
206198+0
2063470.07
219.28202643
202643+0
202659
202659+0
2026510.01
单位质量响应值RSD%判断
10730.4710510.941.47数据可信
长期12月-供试品溶液-2023082121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191685.2
85854+7289*0.8
-91685.245.24141.625.6045.2441.625.60
283694.6
78213+6852*0.8
-83694.641.29841.30
381427.8
76035+6741*0.8
-81427.840.18040.18
487429.4
81719+7138*0.8
-87429.443.14143.14
578154.4
73200+6193*0.8
-78154.438.56438.56
683644.8
78244+6751*0.8
-83644.841.27441.27
10min1149182.2
139647+11919*0.8
-149182.273.61271.611.7974.1272.071.80
2144345.6
134944+11752*0.8
-144345.671.22671.68
3145716.8
136204+11891*0.8
-145716.871.90272.35
4143348.4
133958+11738*0.8
-143348.470.73471.21
5141768
132436+11665*0.8
-14176869.95470.38
6146367.6
136858+11887*0.8
-146367.672.22472.68
15min1174087.4
161825+15328*0.8
-174087.485.90284.461.4587.2285.711.45
2171911.2
159692+15274*0.8
-171911.284.82886.08
3169623.8
157535+15111*0.8
-169623.883.69984.94
4167864.2
155809+15069*0.8
-167864.282.83184.10
5169784.4
157718+15083*0.8
-169784.483.77884.98
6173680.2
159821+17324*0.8
-173680.285.70186.96
20min1188276.8
173424+18566*0.8
-188276.892.90391.282.2595.1893.482.22
2190019.2
174400+19524*0.8
-190019.293.76395.96
3181072.6
166587+18107*0.8
-181072.689.34891.52
4179176.2
164829+17934*0.8
-179176.288.41390.60
5185593.6
170888+18382*0.8
-185593.691.57993.72
6185844.8
171132+18391*0.8
-185844.891.70393.92
30min1192726
167226+31875*0.8
-19272695.09993.791.3298.4197.001.32
2190148.8
164516+32041*0.8
-190148.893.82797.06
3186755.4
162165+30738*0.8
-186755.492.15395.32
4187320.4
162762+30698*0.8
-187320.492.43195.60
5191437.4
166339+31373*0.8
-191437.494.46397.62
6192004.8
166904+31376*0.8
-192004.894.74397.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1191250.2
158963+40359*0.8
-191250.294.37094.611.1798.7398.861.12
2192380
159648+40915*0.8
-19238094.92899.21
3189271
157379+39865*0.8
-18927193.39497.59
4195706.2
162943+40954*0.8
-195706.296.569100.76
5190103.4
158389+39643*0.8
-190103.493.80598.01
6191648.4
159514+40168*0.8
-191648.494.56798.85
60min1184637.4
143511+51408*0.8
-184637.491.10792.601.2896.5297.901.19
2186903.8
145171+52166*0.8
-186903.892.22697.56
3185722.8
144242+51851*0.8
-185722.891.64396.87
4190942.2
148543+52999*0.8
-190942.294.21899.49
5188104.2
146701+51754*0.8
-188104.292.81898.06
6189681.8
147617+52581*0.8
-189681.893.59798.93
极限1184625.4
139467+56448*0.8
-184625.491.10292.171.2397.5398.511.15
2186167.4
140429+57173*0.8
-186167.491.86298.22
3184015.4
138969+56308*0.8
-184015.490.80197.05
4189820.6
143695+57657*0.8
-189820.693.66599.98
5187393.6
141836+56947*0.8
-187393.692.46798.74
6188757.2
142486+57839*0.8
-188757.293.14099.52
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