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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
1 10.953806133807433804153804993804653805470.04
2 10.963781663782803782230.03
单位质量响应值RSD%判断
34753.1534509.400.50数据可信
供试品溶液-t2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148795-4879512.67111.4023.4612.6711.4023.44
250832-5083213.20013.20
332065-320658.3278.33
10min137060-370609.6248.5822.979.648.6022.97
237773-377739.8099.83
324290-242906.3086.32
15min1132490-13249034.40432.8910.2534.4432.9210.26
2135661-13566135.22835.27
3111781-11178129.02729.05
20min1114881-11488129.83226.1122.4729.9326.2022.45
2112275-11227529.15529.25
374516-7451619.35019.42
30min1176257-17625745.77044.995.6245.9145.125.65
2181123-18112347.03347.18
3162368-16236842.16342.27
45min1169747-16974744.07941.4411.9844.3041.6511.99
2171467-17146744.52644.75
3137533-13753335.71435.89
60min1198629-19862951.57951.164.3351.8751.444.37
2204633-20463353.13853.44
3187828-18782848.77449.01
极限1195967-19596750.88848.988.3551.2749.348.37
2199338-19933851.76352.15
3170550-17055044.28844.60
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
1 10.953781043780783780553780513780663780710.01
2 10.963769193767323768260.04
单位质量响应值RSD%判断
34527.0334381.930.30数据可信
供试品溶液-1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115912-159124.1532.8939.084.152.8939.00
27611-76111.9871.99
39664-96642.5222.52
10min156143-5614314.65413.1112.9814.6613.1112.98
243244-4324411.28711.29
351264-5126413.38013.38
15min144783-4478311.6898.1339.0811.728.1639.01
221341-213415.5705.59
327353-273537.1397.17
20min1188652-18865249.23944.0211.8949.2944.0611.90
2148559-14855938.77538.81
3168794-16879444.05644.09
30min155273-5527314.42710.7430.6514.5610.8630.51
230978-309788.0858.18
337245-372459.7219.83
45min1263439-26343968.75966.684.7368.9266.814.75
2241596-24159663.05863.17
3261384-26138468.22368.35
60min160996-6099615.92012.4225.5016.1912.6725.22
237336-373369.7459.96
344482-4448211.61011.85
极限1288214-28821475.22674.422.3675.5274.682.39
2277399-27739972.40372.63
3289724-28972475.62075.88
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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%
1 10.953764913762213768373766123767243765770.07
2 10.963772213772893772550.02
单位质量响应值RSD%判断
34390.5934421.080.07数据可信
供试品溶液-1批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139751-3975110.39014.2846.1710.3914.2846.19
283732-8373221.88521.89
340366-4036610.55110.55
10min1107801-10780128.17630.5322.5928.1930.5522.62
2146490-14649038.28938.33
396088-9608825.11525.13
15min1147765-14776538.62239.5414.3638.6939.6214.40
2174560-17456045.62645.73
3131552-13155234.38434.44
20min1172708-17270845.14145.3710.1445.2745.5110.18
2191578-19157850.07450.25
3156429-15642940.88741.00
30min1204353-20435353.41353.056.0153.6253.276.06
2214435-21443556.04856.31
3190159-19015949.70349.89
45min1231595-23159560.53360.063.1360.8360.373.18
2235899-23589961.65862.01
3221870-22187057.99158.26
60min1248190-24819064.87064.411.9165.2664.811.96
2249989-24998965.34165.80
3241091-24109163.01563.38
极限1258574-25857467.58567.091.0768.0967.601.11
2257890-25789067.40667.97
3253550-25355066.27166.74
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