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%
111.011914471915691915121915281918851915880.09
211.071928721927571928140.05
单位质量响应值RSD%判断
17401.2717417.710.07数据可信
供试品溶液-24071601批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
40min1107037-10703755.19055.143.8955.1955.143.89
2113469-11346958.50658.51
3107342-10734255.34755.35
4108751-10875156.07456.07
5101873-10187352.52752.53
6103139-10313953.18053.18
5min1133658-13365868.91668.982.9269.0169.082.92
2139611-13961171.98672.08
3134153-13415369.17169.26
4135847-13584770.04570.14
5128206-12820666.10566.19
6131272-13127267.68667.77
10min1147111-14711175.85375.892.1176.0676.102.11
2152067-15206778.40878.63
3147301-14730175.95176.16
4148801-14880176.72476.93
5144017-14401774.25774.46
6143828-14382874.16074.36
15min1154810-15481079.82280.581.7380.1680.921.73
2161245-16124583.14083.49
3155837-15583780.35280.69
4157217-15721781.06481.40
5153871-15387179.33879.66
6154713-15471379.77280.10
20min1168812-16881287.04286.771.1787.5187.241.18
2171926-17192688.64889.13
3167692-16769286.46586.93
4167771-16777186.50586.98
5166288-16628885.74186.19
6167198-16719886.21086.67
30min1178009-17800991.78492.440.6192.4093.050.61
2180282-18028292.95693.59
3178113-17811391.83892.45
4179792-17979292.70493.32
5180539-18053993.08993.69
6178938-17893892.26392.86
45min1185642-18564295.72095.920.7696.4896.690.76
2188209-18820997.04397.83
3184031-18403194.88995.65
4186687-18668796.25997.03
5185354-18535495.57196.32
6186316-18631696.06796.82
60min1190403-19040398.17598.400.7399.1099.320.73
2192767-19276799.394100.34
3188559-18855997.22498.15
4191095-19109598.53299.46
5191444-19144498.71199.62
6190730-19073098.34399.26
极限1-0.0000.00-1.091.091.38
2-0.0001.12
3-0.0001.09
4-0.0001.10
5-0.0001.08
6-0.0001.08
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%
111.011930711929611929981931021928491929960.06
211.071918001919281918640.05
单位质量响应值RSD%判断
17529.1617331.890.81数据可信
供试品溶液-24071601批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
40min1127315-12731565.56861.963.2965.5761.963.29
2120165-12016561.88661.89
3115057-11505759.25559.26
4120505-12050562.06162.06
5119483-11948361.53561.53
6119372-11937261.47861.48
5min1152882-15288278.73675.852.1278.8475.962.12
2147779-14777976.10876.21
3143939-14393974.13074.23
4145092-14509274.72474.83
5146375-14637575.38575.49
6147635-14763576.03376.14
10min1164633-16463384.78882.022.0185.0382.252.01
2160063-16006382.43482.66
3157253-15725380.98781.21
4156710-15671080.70780.94
5156272-15627280.48280.71
6160625-16062582.72382.95
15min1171255-17125588.19886.961.1388.5887.321.14
2169786-16978687.44187.81
3166316-16631685.65486.01
4167127-16712786.07286.43
5168360-16836086.70787.07
6170229-17022987.67088.04
20min1180806-18080693.11792.260.9693.6592.770.97
2180858-18085893.14493.66
3177055-17705591.18591.69
4177593-17759391.46291.97
5178196-17819691.77392.28
6180312-18031292.86293.38
30min1188677-18867797.17096.340.9697.8597.000.96
2188942-18894297.30797.98
3184262-18426294.89795.55
4186005-18600595.79496.45
5186642-18664296.12296.78
6187840-18784096.73997.41
45min1191866-19186698.81398.700.9199.6699.530.91
2193851-19385199.835100.67
3189079-18907997.37898.19
4190875-19087598.30299.12
5190975-19097598.35499.17
6193259-19325999.530100.36
60min1193679-19367999.747100.291.10100.76101.281.10
2196909-196909101.410102.41
3191277-19127798.51099.48
4196513-196513101.206102.19
5194096-19409699.961100.95
6195906-195906100.893101.89
极限1-0.0000.00-1.181.161.28
2-0.0001.17
3-0.0001.14
4-0.0001.15
5-0.0001.15
6-0.0001.16
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