非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.873805253819643813813816773816763814450.15
210.703733383729483731430.08
单位质量响应值RSD%判断
35091.5434873.180.45数据可信
供试品溶液-24072901批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1139966-13996636.01032.188.1036.0132.188.10
2118781-11878130.55930.56
3133538-13353834.35634.36
4121577-12157731.27931.28
5124516-12451632.03532.03
6112165-11216528.85728.86
10min1209289-20928953.84550.515.6853.9050.565.68
2182344-18234446.91346.96
3206252-20625253.06353.12
4184530-18453047.47547.53
5200495-20049551.58251.64
6194996-19499650.16850.22
15min1235671-23567160.63258.804.9860.7858.944.98
2210468-21046854.14854.28
3234030-23403060.21060.36
4217993-21799356.08456.22
5236121-23612160.74860.89
6236971-23697160.96761.10
20min1249943-24994364.30462.994.5264.5563.224.52
2226761-22676158.34058.56
3248357-24835763.89664.14
4236163-23616360.75960.98
5252021-25202164.83965.08
6255769-25576965.80366.04
30min1264886-26488668.14967.443.2768.5167.783.27
2247895-24789563.77764.09
3261426-26142667.25867.61
4257823-25782366.33166.66
5270151-27015169.50369.85
6270642-27064269.62969.97
45min1273971-27397170.48670.352.7270.9670.802.72
2260599-26059967.04667.47
3270883-27088369.69170.16
4273993-27399370.49270.93
5279895-27989572.01072.47
6281277-28127772.36672.82
60min1280877-28087772.26371.752.6072.8572.322.60
2265906-26590668.41168.95
3275582-27558270.90071.48
4281153-28115372.33472.89
5285482-28548273.44774.03
6284306-28430673.14573.72
极限1290147-29014774.64873.361.1975.3674.051.21
2280184-28018472.08472.73
3285915-28591573.55974.26
4282800-28280072.75773.43
5285792-28579273.52774.23
6285965-28596573.57274.27
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.873784703782113781233781713783763782700.04
210.703706263708843707550.05
单位质量响应值RSD%判断
34799.4534650.000.31数据可信
供试品溶液-24073101批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1110235-11023528.57138.8419.1428.5738.8419.15
2119681-11968131.01931.02
3168304-16830443.62143.62
4183057-18305747.44547.45
5155356-15535640.26640.27
6162471-16247142.11042.11
10min1247230-24723064.07866.985.2464.1367.045.25
2236617-23661761.32761.38
3271424-27142470.34870.42
4266426-26642669.05369.13
5266548-26654869.08569.15
6262207-26220767.95968.03
15min1292723-29272375.86976.382.6476.0276.562.65
2281930-28193073.07173.23
3303513-30351378.66578.86
4296620-29662076.87977.07
5301481-30148178.13978.32
6291859-29185975.64575.83
20min1310979-31097980.60080.661.8680.8880.971.87
2303489-30348978.65978.93
3318749-31874982.61482.94
4308618-30861879.98880.31
5317134-31713482.19682.51
6308346-30834679.91880.23
30min1330242-33024285.59385.551.6086.0185.991.60
2327919-32791984.99185.40
3335136-33513686.86187.32
4323253-32325383.78284.24
5337247-33724787.40987.86
6326745-32674584.68785.13
45min1343430-34343089.01188.841.7889.5789.421.78
2339572-33957288.01188.56
3346632-34663289.84190.44
4334689-33468986.74687.34
5352118-35211891.26391.86
6340081-34008188.14388.73
60min1349704-34970490.63790.521.7691.3491.251.76
2348359-34835990.28990.98
3352870-35287091.45892.21
4341342-34134288.47089.21
5358707-35870792.97193.72
6344540-34454089.29990.03
极限1357293-35729392.60491.991.6793.4692.861.66
2356514-35651492.40293.25
3360025-36002593.31294.22
4346153-34615389.71790.60
5360374-36037493.40394.30
6349083-34908390.47691.36
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