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%
110.853736853728663733733739333721883732090.19
210.863693793718943706360.48
单位质量响应值RSD%判断
34397.1434128.550.56数据可信
供试品溶液-24072301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%
5min1147631-14763138.74936.4711.0738.7536.4711.07
2121192-12119231.80931.81
3148004-14800438.84638.85
10min1146900-14690038.55742.1413.8838.6242.2013.84
2186272-18627248.89148.94
3148537-14853738.98639.05
15min1227742-22774259.77558.005.6059.9058.135.57
2206707-20670754.25454.39
3228460-22846059.96460.09
20min1232445-23244561.01063.717.2361.2463.947.20
2262965-26296569.02069.25
3232774-23277461.09661.33
30min1264186-26418669.34167.694.1969.6768.034.16
2245453-24545364.42464.76
3264100-26410069.31869.65
45min1268860-26886070.56772.644.6871.0173.084.65
2291663-29166376.55377.00
3269688-26968870.78571.23
60min1287188-28718875.37873.942.8675.9474.512.83
2272476-27247671.51772.09
3285510-28551074.93875.50
极限1287317-28731775.41277.453.4776.1078.143.44
2306651-30665180.48681.18
3291228-29122876.43877.13
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%
110.853682943708943699413715303689713699260.36
210.863704923716623710770.23
单位质量响应值RSD%判断
34094.5634169.150.16数据可信
供试品溶液-24072301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%
5min1148467-14846739.11726.8140.2839.1226.8140.30
271715-7171518.89518.89
385133-8513322.43022.43
10min174111-7411119.52628.7727.8719.5928.8227.77
2128381-12838133.82533.86
3125102-12510232.96133.00
15min1239099-23909962.99656.7015.6463.0956.7915.62
2176725-17672546.56246.65
3229760-22976060.53560.63
20min1169622-16962244.69151.2711.2744.8951.4611.21
2210686-21068655.51055.68
3203477-20347753.61153.80
30min1271662-27166271.57667.1211.1271.8567.3911.10
2222052-22205258.50558.76
3270543-27054371.28171.56
45min1215583-21558356.80061.596.8857.2061.976.81
2246117-24611764.84565.20
3239562-23956263.11863.52
60min1287730-28773075.80972.579.2476.3073.059.21
2246158-24615864.85665.32
3292371-29237177.03277.54
极限1243421-24342164.13567.624.5264.7568.224.46
2265006-26500669.82270.39
3261492-26149268.89669.53
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%
110.853690573704343710053691733691743697690.25
210.863704103680603692350.46
单位质量响应值RSD%判断
34080.0933999.540.17数据可信
供试品溶液-24072301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%
5min155101-5510114.55727.3950.6314.5627.3950.62
2159334-15933442.09442.09
396572-9657225.51325.51
10min194478-9447824.96030.9021.6724.9830.9421.66
2111961-11196129.57829.65
3144397-14439738.14838.19
15min1153680-15368040.60053.5821.1340.6753.6821.14
2232439-23243961.40761.53
3222297-22229758.72858.83
20min1180371-18037147.65152.8410.8547.7853.0210.87
2196373-19637351.87952.10
3223284-22328458.98859.19
30min1246499-24649965.12167.913.5765.3368.183.63
2262741-26274169.41269.72
3261936-26193669.20069.50
45min1222085-22208558.67262.867.2258.9963.257.24
2235575-23557562.23562.66
3256166-25616667.67568.09
60min1277596-27759673.33773.981.0673.7674.471.12
2279157-27915773.74974.28
3283306-28330674.84575.38
极限1247443-24744365.37168.805.2665.9169.425.29
2259147-25914768.46369.11
3274702-27470272.57273.23
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%
110.853699563680213691543707053683253692320.31
210.863675313690473682890.30
单位质量响应值RSD%判断
34030.6033912.430.25数据可信
供试品溶液-24072301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%
5min188459-8845923.41728.7416.9723.4228.7416.96
2112572-11257229.80029.80
3124628-12462832.99132.99
10min1125672-12567233.26736.1016.5733.3136.1516.56
2121143-12114332.06932.12
3162352-16235242.97743.03
15min1185502-18550249.10553.366.9949.2053.476.99
2211613-21161356.01756.12
3207650-20765054.96855.10
20min1208630-20863055.22855.927.8355.4056.117.83
2196166-19616651.92852.12
3228925-22892560.60060.82
30min1234903-23490362.18365.725.2862.4566.015.27
2261078-26107869.11269.39
3248840-24884065.87266.19
45min1246839-24683965.34264.715.1165.7165.115.10
2230954-23095461.13761.54
3255587-25558767.65868.09
60min1266033-26603370.42373.043.6870.9073.553.67
2286313-28631375.79276.29
3275409-27540972.90573.45
极限1270245-27024571.53869.704.4672.1470.334.42
2249777-24977766.12066.75
3269907-26990771.44972.11
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