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D69223050102 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%
119.26205452
205452+0
205404
205404+0
205318
205318+0
205484
205484+0
205342
205342+0
2054000.04
219.29204206
204206+0
203895
203895+0
2040500.11
单位质量响应值RSD%判断
10664.5910578.020.58数据可信
供试品溶液-23031401批-80mg规格-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126271.2
123864+3009*0.8
-126271.262.29860.3314.6562.3060.3214.66
2138582.8
135990+3241*0.8
-138582.868.37268.37
3114000.4
111834+2708*0.8
-114000.456.24456.24
4105244.8
103308+2421*0.8
-105244.851.92451.92
5102969
101049+2400*0.8
-10296950.80250.80
6146581.6
143800+3477*0.8
-146581.672.31972.32
10min1177263.6
174126+3922*0.8
-177263.687.45688.236.2388.1588.906.29
2187174.8
183582+4491*0.8
-187174.892.34693.11
3177785
174593+3990*0.8
-17778587.71388.34
4167236.2
164205+3789*0.8
-167236.282.50983.09
5167740.2
164581+3949*0.8
-167740.282.75883.32
6195820.8
192364+4321*0.8
-195820.896.61297.42
15min1196328.8
192812+4396*0.8
-196328.896.86294.314.0798.5395.964.15
2195923.4
192409+4393*0.8
-195923.496.66298.45
3189471.2
186052+4274*0.8
-189471.293.47995.08
4184154
180678+4345*0.8
-18415490.85692.35
5180544.8
177172+4216*0.8
-180544.889.07590.56
6200497.8
196889+4511*0.8
-200497.898.919100.80
20min1192227
188731+4370*0.8
-19222794.83994.782.4097.5897.482.53
2193951.4
190505+4308*0.8
-193951.495.68998.55
3192263.4
188653+4513*0.8
-192263.494.85797.49
4186777.2
183270+4384*0.8
-186777.292.15094.65
5187854
184358+4370*0.8
-18785492.68195.15
6199576.2
196085+4364*0.8
-199576.298.464101.44
30min1184351.4
180825+4408*0.8
-184351.490.95392.691.2094.7596.441.25
2189950.8
186322+4536*0.8
-189950.893.71697.64
3189181.8
185521+4576*0.8
-189181.893.33697.03
4185854
182210+4555*0.8
-18585491.69495.22
5188483.2
184756+4659*0.8
-188483.292.99196.49
6189361.4
185819+4428*0.8
-189361.493.42597.49
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1185383
181819+4455*0.8
-18538391.46292.040.7796.2796.820.93
2186835.8
183291+4431*0.8
-186835.892.17997.14
3187552
183832+4650*0.8
-18755292.53297.26
4185132
181324+4760*0.8
-18513291.33895.88
5185686.8
181766+4901*0.8
-185686.891.61296.15
6188787.4
185149+4548*0.8
-188787.493.14298.25
60min1184588.4
180926+4578*0.8
-184588.491.07091.881.2896.8997.681.38
2186694.6
183061+4542*0.8
-186694.692.10998.10
3185808.6
181971+4797*0.8
-185808.691.67297.43
4183123.6
179406+4647*0.8
-183123.690.34795.91
5187024.4
183142+4853*0.8
-187024.492.27297.83
6190105
186437+4585*0.8
-19010593.79299.93
极限1186402.2
181591+6014*0.8
-186402.291.96591.851.1598.8098.681.30
2188150.6
184045+5132*0.8
-188150.692.82799.84
3184494.6
180773+4652*0.8
-184494.691.02497.80
4185180.2
181369+4764*0.8
-185180.291.36297.93
5183679
179835+4805*0.8
-18367990.62197.20
6189129.2
185354+4719*0.8
-189129.293.310100.50
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D69223050102 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%
119.26205024
205024+0
205307
205307+0
204457
204457+0
204683
204683+0
205072
205072+0
2049090.17
219.29204401
204401+0
204342
204342+0
2043720.03
单位质量响应值RSD%判断
10639.1010594.710.30数据可信
供试品溶液-2303140-1批-80mg规格-pH6.8(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141885.2
139954+2414*0.8
-141885.270.03066.358.1270.0366.358.12
2119697.2
117990+2134*0.8
-119697.259.07859.08
3150397.4
148311+2608*0.8
-150397.474.23174.23
4127480
125732+2185*0.8
-12748062.92062.92
5136511.6
134446+2582*0.8
-136511.667.37767.38
6130574.8
128654+2401*0.8
-130574.864.44764.45
10min1184710
182218+3115*0.8
-18471091.16786.683.8091.9487.413.82
2166630
164278+2940*0.8
-16663082.24382.90
3181413.6
178964+3062*0.8
-181413.689.54090.36
4170827.8
168519+2886*0.8
-170827.884.31585.01
5175708.6
173339+2962*0.8
-175708.686.72487.47
6174385.4
171951+3043*0.8
-174385.486.07186.79
15min1196623
194055+3210*0.8
-19662397.04691.273.5098.8492.973.51
2180848.8
178324+3156*0.8
-180848.889.26190.83
3186133.6
183720+3017*0.8
-186133.691.86993.69
4179293.6
176844+3062*0.8
-179293.688.49390.13
5186223.2
183684+3174*0.8
-186223.291.91393.63
6180416
177896+3150*0.8
-18041689.04790.72
20min1198839.8
196223+3271*0.8
-198839.898.14194.032.19101.0196.742.19
2189203.4
186469+3418*0.8
-189203.493.38495.95
3187382.4
184808+3218*0.8
-187382.492.48695.33
4189387.8
186643+3431*0.8
-189387.893.47596.09
5188681.2
185958+3404*0.8
-188681.293.12795.86
6189519.8
186795+3406*0.8
-189519.893.54196.20
30min1191857.2
189070+3484*0.8
-191857.294.69492.451.9198.6596.211.94
2187460.6
184599+3577*0.8
-187460.692.52496.12
3190369.2
187610+3449*0.8
-190369.293.96097.83
4184632.4
181946+3358*0.8
-184632.491.12894.79
5187331.4
184609+3403*0.8
-187331.492.46096.23
6182188.2
179405+3479*0.8
-182188.289.92293.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1190219.4
187413+3508*0.8
-190219.493.88692.711.3098.9097.501.32
2188708.8
185616+3866*0.8
-188708.893.14097.77
3187527.2
184660+3584*0.8
-187527.292.55797.47
4185358.8
182334+3781*0.8
-185358.891.48796.16
5190509
187661+3560*0.8
-19050994.02998.82
6184728.6
181843+3607*0.8
-184728.691.17695.88
60min1192810.4
189708+3878*0.8
-192810.495.16591.941.93101.2297.751.92
2187493
184181+4140*0.8
-18749392.54098.20
3184803.8
181935+3586*0.8
-184803.891.21397.15
4184688.4
181702+3733*0.8
-184688.491.15696.84
5185420.8
182596+3531*0.8
-185420.891.51797.36
6182413.4
179391+3778*0.8
-182413.490.03395.75
极限1187748.2
184729+3774*0.8
-187748.292.66691.591.7399.7898.441.67
2181507.6
178318+3987*0.8
-181507.689.58696.28
3186202.4
183136+3833*0.8
-186202.491.90398.86
4184675.4
181465+4013*0.8
-184675.491.14997.85
5183040.6
180175+3582*0.8
-183040.690.34397.20
6190291.4
187093+3998*0.8
-190291.493.921100.64
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D69223050102 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%
119.26204889
204889+0
204344
204344+0
204500
204500+0
204234
204234+0
203843
203843+0
2043620.19
219.29204215
204215+0
205112
205112+0
2046640.31
单位质量响应值RSD%判断
10610.7010609.850.01数据可信
供试品溶液-23031401批-80mg规格-pH4.5(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194302.4
92524+2223*0.8
-94302.446.57350.245.2646.5750.245.26
2107134.4
105188+2433*0.8
-107134.452.91152.91
396441
94673+2210*0.8
-9644147.63047.63
4101336.6
99399+2422*0.8
-101336.650.04750.05
5106358.8
104334+2531*0.8
-106358.852.52852.53
6104752.8
102764+2486*0.8
-104752.851.73551.73
10min1165312.4
162490+3528*0.8
-165312.481.64382.302.9682.1682.862.96
2165393
162361+3790*0.8
-16539381.68382.27
3160158.4
157376+3478*0.8
-160158.479.09879.63
4165756.6
162903+3567*0.8
-165756.681.86382.42
5175212.8
172236+3721*0.8
-175212.886.53387.12
6167979.6
165094+3607*0.8
-167979.682.96083.54
15min1193205.4
189867+4173*0.8
-193205.495.41992.992.1296.8494.462.11
2189861.2
186534+4159*0.8
-189861.293.76795.26
3183796.2
180341+4319*0.8
-183796.290.77292.18
4185967.6
182834+3917*0.8
-185967.691.84493.31
5192167
188895+4090*0.8
-19216794.90696.45
6184777
181709+3835*0.8
-18477791.25692.75
20min1200339
196895+4305*0.8
-20033998.94295.893.23101.4398.403.10
2191961.6
188924+3797*0.8
-191961.694.80597.34
3203438.8
199646+4741*0.8
-203438.8100.473102.89
4192148.8
188908+4051*0.8
-192148.894.89797.38
5188329.2
185246+3854*0.8
-188329.293.01195.61
6188770.2
185703+3834*0.8
-188770.293.22895.74
30min1207056.6
203599+4322*0.8
-207056.6102.26095.124.62105.8498.694.46
2196415
193131+4105*0.8
-19641597.004100.59
3191993
188917+3845*0.8
-19199394.82098.35
4191654.2
188563+3864*0.8
-191654.294.65398.19
5188152.8
184960+3991*0.8
-188152.892.92396.56
6180349.2
177442+3634*0.8
-180349.289.06992.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1201589.8
198289+4126*0.8
-201589.899.56094.992.86104.2899.622.78
2193245.8
190089+3946*0.8
-193245.895.439100.11
3191199.8
188127+3841*0.8
-191199.894.42899.01
4194224.2
191105+3899*0.8
-194224.295.922100.51
5187536.2
184509+3784*0.8
-187536.292.61997.28
6186269.6
183340+3662*0.8
-186269.691.99396.53
60min1196817.6
193648+3962*0.8
-196817.697.20393.232.43103.0398.912.36
2187087.8
184119+3711*0.8
-187087.892.39798.13
3191664.2
188617+3809*0.8
-191664.294.658100.29
4185978
183018+3700*0.8
-18597891.84997.51
5185955.4
183005+3688*0.8
-185955.491.83897.53
6185124.6
182163+3702*0.8
-185124.691.42896.99
极限1191502.4
188412+3863*0.8
-191502.494.57893.551.74101.48100.271.70
2193757.8
190565+3991*0.8
-193757.895.692102.45
3188802.2
185791+3764*0.8
-188802.293.24499.93
4190412.4
187318+3868*0.8
-190412.494.039100.72
5187871.6
184846+3782*0.8
-187871.692.78599.50
6184228.6
181359+3587*0.8
-184228.690.98597.56
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D69223050102 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%
119.26199173
199173+0
202047
202047+0
202195
202195+0
201802
201802+0
201815
201815+0
2014060.63
219.29200603
200603+0
200874
200874+0
2007380.10
单位质量响应值RSD%判断
10457.2210406.320.35数据可信
供试品溶液-2303140-1批-80mg规格-pH4.5(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194753.6
93332+1777*0.8
-94753.647.59749.824.1547.6049.824.15
2102274.8
100774+1876*0.8
-102274.851.37551.38
396367
94891+1845*0.8
-9636748.40848.41
4100848
99344+1880*0.8
-10084850.65950.66
595825.2
94398+1784*0.8
-95825.248.13548.14
6104969.2
103258+2139*0.8
-104969.252.72952.73
10min1156522.8
154466+2571*0.8
-156522.878.62582.133.2879.1582.693.27
2162076.2
159869+2759*0.8
-162076.281.41581.99
3167595.8
165375+2776*0.8
-167595.884.18884.73
4167983.8
165731+2816*0.8
-167983.884.38384.95
5158156.8
156060+2621*0.8
-158156.879.44679.98
6168692.8
166244+3061*0.8
-168692.884.73985.32
15min1178210.6
175961+2812*0.8
-178210.689.52091.752.2890.9293.222.29
2180652
178268+2980*0.8
-18065290.74692.22
3187571
185179+2990*0.8
-18757194.22295.70
4185414.2
183023+2989*0.8
-185414.293.13894.64
5178183.6
175930+2817*0.8
-178183.689.50690.92
6185891.2
183412+3099*0.8
-185891.293.37894.91
20min1188127
185671+3070*0.8
-18812794.50195.832.6296.9098.322.61
2191644.6
189231+3017*0.8
-191644.696.26898.75
3192770.2
190295+3094*0.8
-192770.296.83499.35
4188252.8
185888+2956*0.8
-188252.894.56497.10
5184730.2
182395+2919*0.8
-184730.292.79595.21
6199142.2
196471+3339*0.8
-199142.2100.034102.60
30min1188994.4
186760+2793*0.8
-188994.494.93795.061.7598.3898.611.66
2189331.4
186997+2918*0.8
-189331.495.10698.66
3190804.2
188477+2909*0.8
-190804.295.84699.44
4193558.8
191146+3016*0.8
-193558.897.230100.82
5189295.8
187023+2841*0.8
-189295.895.08898.53
6183454.2
181055+2999*0.8
-183454.292.15495.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
45min1186469.8
184193+2846*0.8
-186469.893.66994.771.9998.1799.381.92
2187889.4
185639+2813*0.8
-187889.494.38298.99
3188874
186638+2795*0.8
-18887494.87699.54
4195647.2
193188+3074*0.8
-195647.298.279102.95
5188388.6
186139+2812*0.8
-188388.694.63399.13
6184728
182280+3060*0.8
-18472892.79497.49
60min1184586.4
182384+2753*0.8
-184586.492.72394.422.6198.27100.082.44
2195686.6
193337+2937*0.8
-195686.698.298103.96
3190575.8
188307+2836*0.8
-190575.895.731101.45
4183401
181065+2920*0.8
-18340192.12797.89
5189785.4
187451+2918*0.8
-189785.495.334100.89
6183777.4
181335+3053*0.8
-183777.492.31698.05
极限1183775.2
181508+2834*0.8
-183775.292.31593.511.6898.89100.211.58
2189217.6
186880+2922*0.8
-189217.695.049101.80
3188989.8
186733+2821*0.8
-188989.894.935101.71
4184875
182599+2845*0.8
-18487592.86899.65
5188292.4
186078+2768*0.8
-188292.494.584101.19
6181727.6
179426+2877*0.8
-181727.691.28798.04
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