盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.262009412005312002542004382008582006040.15
211.322016532016732016630.01
单位质量响应值RSD%判断
17815.6317814.750.01数据可信
供试品溶液-T0704607DD批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138642-3864219.47121.127.3519.4721.127.37
246077-4607723.21723.22
341328-4132820.82420.82
439483-3948319.89419.89
545302-4530222.82622.83
640625-4062520.47020.47
10min1105388-10538853.10254.934.6353.1354.964.63
2111145-11114556.00356.04
3110034-11003455.44355.48
4104897-10489752.85552.89
5117666-11766659.28959.33
6104965-10496552.88952.92
15min1160185-16018580.71380.441.8180.8380.571.81
2159632-15963280.43480.57
3161718-16171881.48581.61
4155920-15592078.56478.69
5163573-16357382.42082.56
6156888-15688879.05279.17
20min1177660-17766089.51889.420.9789.7789.680.97
2177873-17787389.62589.89
3179447-17944790.41990.68
4174382-17438287.86688.12
5178393-17839389.88790.16
6177024-17702489.19889.45
30min1190066-19006695.76995.730.9196.1796.130.91
2191074-19107496.27796.69
3192329-19232996.90997.32
4187705-18770594.58094.98
5188320-18832094.88995.31
6190384-19038495.92996.33
45min1195511-19551198.51398.510.7999.0899.080.79
2196349-19634998.93599.51
3197673-19767399.602100.18
4193211-19321197.35497.91
5194462-19446297.98498.57
6195852-19585298.68599.25
60min1196154-19615498.83798.920.7699.5799.650.76
2197111-19711199.319100.06
3198743-198743100.141100.88
4194471-19447197.98998.71
5195284-19528498.39899.14
6196147-19614798.83399.56
极限1195704-19570498.61098.790.8299.5099.690.82
2197215-19721599.371100.28
3198159-19815999.847100.76
4194300-19430097.90398.78
5194254-19425497.87998.79
6196788-19678899.156100.05
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.262009432004772004002003282004412005180.13
211.322026282023892025080.09
单位质量响应值RSD%判断
17807.9917889.400.33数据可信
供试品溶液-T0704607DD批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138052-3805219.13720.957.5219.1420.957.51
245675-4567522.97122.97
339559-3955919.89519.90
441894-4189421.07021.07
539680-3968019.95619.96
645042-4504222.65322.65
10min1104873-10487352.74454.003.0252.7854.043.03
2109859-10985955.25155.29
3107985-10798554.30954.34
4109442-10944255.04255.08
5102056-10205651.32751.36
6110051-11005155.34855.39
15min1159480-15948080.20780.041.1780.3380.171.18
2160837-16083780.89081.02
3156284-15628478.60078.72
4160835-16083580.88981.02
5157542-15754279.23379.35
6159938-15993880.43880.57
20min1175909-17590988.47088.681.0788.7288.941.07
2179218-17921890.13490.40
3173371-17337187.19387.45
4176622-17662288.82989.09
5176685-17668588.86089.11
6176153-17615388.59388.86
30min1187646-18764694.37395.001.3794.7795.401.37
2192390-19239096.75997.17
3184797-18479792.94093.34
4188727-18872794.91695.33
5190488-19048895.80296.20
6189295-18929595.20295.61
45min1194208-19420897.67397.831.3498.2398.401.34
2198085-19808599.623100.20
3190448-19044895.78296.34
4193543-19354397.33997.91
5196386-19638698.76899.33
6194467-19446797.80398.37
60min1195027-19502798.08598.201.3898.8198.931.38
2199244-199244100.206100.95
3191509-19150996.31697.03
4193712-19371297.42498.15
5197162-19716299.15999.88
6194915-19491598.02998.76
极限1194707-19470797.92498.481.6198.8199.371.61
2201675-201675101.428102.34
3193018-19301897.07597.95
4193758-19375897.44798.34
5196845-19684598.99999.89
6194852-19485297.99798.89
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