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%
119.23204817
204817+0
205006
205006+0
205113
205113+0
205041
205041+0
205037
205037+0
2050030.06
219.28206107
206107+0
206087
206087+0
2060970.01
单位质量响应值RSD%判断
10660.5810689.680.20数据可信
长期12月-供试品溶液-2023082521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%
5min190871.8
86175+5871*0.8
-90871.844.60647.494.8344.6147.494.83
297119.6
91926+6492*0.8
-97119.647.67347.67
3104337.8
98793+6931*0.8
-104337.851.21751.22
496680.8
91416+6581*0.8
-96680.847.45847.46
598408.8
93080+6661*0.8
-98408.848.30648.31
693041
87969+6340*0.8
-9304145.67145.67
10min1136113.6
128580+9417*0.8
-136113.666.81469.762.5767.3170.292.57
2145062.2
136747+10394*0.8
-145062.271.20771.74
3145281.6
136856+10532*0.8
-145281.671.31571.88
4144668.2
136145+10654*0.8
-144668.271.01471.54
5139937
131757+10225*0.8
-13993768.69169.23
6141633.6
133300+10417*0.8
-141633.669.52470.03
15min1162011.6
151942+12587*0.8
-162011.679.52780.951.6780.7782.251.64
2166595.4
155957+13298*0.8
-166595.481.77783.10
3161052.6
150651+13002*0.8
-161052.679.05680.42
4168022.2
157167+13569*0.8
-168022.282.47783.79
5165757.8
155137+13276*0.8
-165757.881.36682.67
6166001
155349+13315*0.8
-16600181.48582.77
20min1164797
149977+18525*0.8
-16479780.89483.972.2383.0286.172.21
2169545.4
154011+19418*0.8
-169545.483.22585.45
3173544.2
157513+20039*0.8
-173544.285.18887.43
4175167.2
159080+20109*0.8
-175167.285.98588.22
5169749.4
154195+19443*0.8
-169749.483.32585.53
6173523.2
157644+19849*0.8
-173523.285.17887.36
30min1176650.2
157663+23734*0.8
-176650.286.71388.801.3489.7391.931.35
2180531.4
160941+24488*0.8
-180531.488.61891.77
3180547.4
160833+24643*0.8
-180547.488.62691.81
4183839
163803+25045*0.8
-18383990.24293.43
5182254.4
162544+24638*0.8
-182254.489.46492.59
6181550
161774+24720*0.8
-18155089.11892.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1178520
146020+40625*0.8
-17852087.63189.751.3291.6193.871.33
2183871.2
150380+41864*0.8
-183871.290.25794.40
3183951.2
150072+42349*0.8
-183951.290.29794.47
4183937.6
150468+41837*0.8
-183937.690.29094.48
5181640.2
148645+41244*0.8
-181640.289.16293.29
6185107.8
151851+41571*0.8
-185107.890.86494.99
60min1177954.2
137787+50209*0.8
-177954.287.35389.761.8592.3194.881.82
2181079.4
140217+51078*0.8
-181079.488.88794.03
3183051.8
141231+52276*0.8
-183051.889.85595.03
4187383.8
145203+52726*0.8
-187383.891.98297.18
5185739
144215+51905*0.8
-18573991.17496.29
6181894.8
141378+50646*0.8
-181894.889.28794.42
极限1179985.4
135851+55168*0.8
-179985.488.35089.151.1394.2895.271.12
2180226.8
135894+55416*0.8
-180226.888.46894.60
3183179.2
137808+56714*0.8
-183179.289.91896.09
4183673
138433+56550*0.8
-18367390.16096.38
5179152.8
135484+54586*0.8
-179152.887.94194.07
6183502.8
138850+55816*0.8
-183502.890.07796.20
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%
119.23205227
205227+0
205083
205083+0
205109
205109+0
204982
204982+0
205126
205126+0
2051050.05
219.28206605
206605+0
205976
205976+0
2062900.22
单位质量响应值RSD%判断
10665.8910699.690.23数据可信
长期12月-供试品溶液-2023082621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191498.4
85920+6973*0.8
-91498.444.88244.952.2344.8844.942.23
289726.2
84407+6649*0.8
-89726.244.01344.01
391745
86241+6880*0.8
-9174545.00345.00
489934.4
84668+6583*0.8
-89934.444.11544.11
595392.6
89723+7087*0.8
-95392.646.79246.79
691481.4
86023+6823*0.8
-91481.444.87444.87
10min1141240.2
132673+10709*0.8
-141240.269.28170.032.0369.7870.532.02
2142083.6
133386+10872*0.8
-142083.669.69570.18
3139417
130741+10845*0.8
-13941768.38768.89
4141251.4
132669+10728*0.8
-141251.469.28769.78
5145797.4
136747+11313*0.8
-145797.471.51772.04
6146794.6
137725+11337*0.8
-146794.672.00672.50
15min1168705.8
157253+14316*0.8
-168705.882.75482.261.5584.0283.541.55
2166328.2
155021+14134*0.8
-166328.281.58782.85
3163233.2
152058+13969*0.8
-163233.280.06981.33
4167975.2
156760+14019*0.8
-167975.282.39583.66
5170305.4
158631+14593*0.8
-170305.483.53884.85
6169694.8
158110+14481*0.8
-169694.883.23984.54
20min1179102.2
165395+17134*0.8
-179102.287.85389.132.4090.0491.322.38
2175393.6
161980+16767*0.8
-175393.686.03488.20
3180411.6
166806+17007*0.8
-180411.688.49690.65
4182345.6
168744+17002*0.8
-182345.689.44491.62
5187068.2
172889+17724*0.8
-187068.291.76194.00
6185874.4
171820+17568*0.8
-185874.491.17593.40
30min1184562.8
161402+28951*0.8
-184562.890.53293.121.4793.7096.311.45
2188942
165478+29330*0.8
-18894292.68095.81
3191157.2
167582+29469*0.8
-191157.293.76796.90
4191061
167469+29490*0.8
-19106193.71996.89
5191476
167508+29960*0.8
-19147693.92397.19
6191895
168079+29770*0.8
-19189594.12997.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1189598.2
159263+37919*0.8
-189598.293.00295.002.0297.1799.221.96
2190391.2
160536+37319*0.8
-190391.293.39197.55
3198705.6
167724+38727*0.8
-198705.697.469101.64
4190996.6
161239+37197*0.8
-190996.693.68897.90
5194802.4
164184+38273*0.8
-194802.495.55599.86
6197520
166644+38595*0.8
-19752096.888101.17
60min1180617.8
141257+49201*0.8
-180617.888.59792.772.4393.8098.042.34
2188189.2
147758+50539*0.8
-188189.292.31197.50
3191503.8
150615+51111*0.8
-191503.893.93799.19
4192685
151653+51290*0.8
-19268594.51699.77
5192789.8
151565+51531*0.8
-192789.894.56799.94
6188918.2
148799+50149*0.8
-188918.292.66898.03
极限1181966
138750+54020*0.8
-18196689.25891.751.4295.4598.051.40
2187056.8
142588+55586*0.8
-187056.891.75597.97
3189062.6
144237+56032*0.8
-189062.692.73999.04
4186868.6
142683+55232*0.8
-186868.691.66397.96
5188809.8
144121+55861*0.8
-188809.892.61599.03
6188503.4
143821+55853*0.8
-188503.492.46598.85
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%
119.23204812
204812+0
204712
204712+0
204687
204687+0
204544
204544+0
204577
204577+0
2046660.06
219.28204884
204884+0
205132
205132+0
2050080.09
单位质量响应值RSD%判断
10643.0610633.200.07数据可信
长期12月-供试品溶液-2023082621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191200
85440+7200*0.8
-9120044.92344.912.5744.9244.902.57
289756.4
84198+6948*0.8
-89756.444.21244.21
391051.8
85279+7216*0.8
-91051.844.85044.85
494325.4
88399+7408*0.8
-94325.446.46346.46
592980.2
87141+7299*0.8
-92980.245.80045.80
687691
82259+6790*0.8
-8769143.19543.19
10min1138486.6
129417+11337*0.8
-138486.668.21669.741.9068.7170.241.90
2143525.8
134121+11756*0.8
-143525.870.69871.19
3141238.6
131789+11812*0.8
-141238.669.57170.07
4142471.2
133100+11714*0.8
-142471.270.17870.69
5145195.2
135580+12019*0.8
-145195.271.52072.03
6138624.2
129693+11164*0.8
-138624.268.28368.76
15min1166152.6
154147+15007*0.8
-166152.681.84382.781.4383.1084.061.43
2169129.8
156809+15401*0.8
-169129.883.31084.59
3164643
152647+14995*0.8
-16464381.10082.37
4170161
157817+15430*0.8
-17016183.81885.11
5170791.4
158413+15473*0.8
-170791.484.12885.43
6167505
155657+14810*0.8
-16750582.50983.75
20min1180706.2
166247+18074*0.8
-180706.289.01289.801.7891.1892.001.75
2176835
162607+17785*0.8
-17683587.10589.31
3182830
168198+18290*0.8
-18283090.05892.23
4184020.6
169295+18407*0.8
-184020.690.64592.87
5186313.2
171450+18579*0.8
-186313.291.77494.01
6183188.8
168744+18056*0.8
-183188.890.23592.39
30min1180914
158062+28565*0.8
-18091489.11492.462.4292.2795.652.38
2187597.4
163659+29923*0.8
-187597.492.40795.58
3186593.6
163248+29182*0.8
-186593.691.91295.09
4192524.6
168423+30127*0.8
-192524.694.83498.07
5192988.8
169036+29941*0.8
-192988.895.06298.32
6185595.8
162835+28451*0.8
-185595.891.42194.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1187291.8
157747+36931*0.8
-187291.892.25694.161.4796.4098.381.46
2191779.4
161025+38443*0.8
-191779.494.46798.66
3190880
160724+37695*0.8
-19088094.02498.22
4195664.4
164702+38703*0.8
-195664.496.380100.67
5191880.4
161914+37458*0.8
-191880.494.51698.83
6189438.4
159720+37148*0.8
-189438.493.31397.49
60min1181974.2
142527+49309*0.8
-181974.289.63792.512.0194.8197.781.90
2191842.2
150055+52234*0.8
-191842.294.49799.74
3190218.6
149313+51132*0.8
-190218.693.69898.94
4186103.2
146320+49729*0.8
-186103.291.67197.03
5185998.2
146519+49349*0.8
-185998.291.61996.98
6190747
150127+50775*0.8
-19074793.95899.17
极限1190282.6
145149+56417*0.8
-190282.693.72992.951.3599.9099.241.28
2187955.2
142612+56679*0.8
-187955.292.58398.88
3184867.4
140693+55218*0.8
-184867.491.06297.34
4188339.4
143189+56438*0.8
-188339.492.77299.15
5192472.8
146800+57091*0.8
-192472.894.808101.19
6188312.6
143623+55862*0.8
-188312.692.75999.01
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