盐酸鲁拉西酮片项目信息
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%
111.021979091976471975801974791971311975490.15
211.141948421950541949480.08
单位质量响应值RSD%判断
17926.4117499.821.71数据可信
供试品溶液-24052101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%
5min1133134-13313467.47967.394.7467.4867.394.74
2136663-13666369.26869.27
3133072-13307267.44867.45
4123564-12356462.62862.63
5142031-14203171.98871.99
6129239-12923965.50565.50
10min1157417-15741779.78779.903.3979.9080.023.39
2161152-16115281.68081.80
3158391-15839180.28180.39
4148577-14857775.30675.41
5164300-16430083.27683.40
6156033-15603379.08579.19
15min1167741-16774185.02085.123.2085.2785.373.20
2171360-17136086.85487.11
3169558-16955885.94186.19
4157861-15786180.01280.24
5173212-17321287.79388.05
6167902-16790285.10185.34
20min1172539-17253987.45188.402.0587.8488.792.05
2177380-17738089.90590.30
3175069-17506988.73489.12
4168291-16829185.29885.66
5177934-17793490.18690.59
6175269-17526988.83589.22
30min1181284-18128491.88492.481.2292.4293.021.23
2184063-18406393.29293.84
3183327-18332792.91993.46
4178630-17863090.53991.04
5184734-18473493.63394.19
6182741-18274192.62293.15
45min1186372-18637294.46395.922.2495.1596.612.23
2189567-18956796.08296.78
3189344-18934495.96996.66
4184072-18407293.29793.95
5189564-18956496.08196.79
6196604-19660499.649100.33
60min1189487-18948796.04296.830.9696.8997.680.97
2191757-19175797.19298.05
3192459-19245997.54898.40
4188126-18812695.35296.16
5191732-19173297.17998.05
6192666-19266697.65398.50
极限1191987-19198797.30998.470.8798.3199.480.87
2194933-19493398.80299.83
3195503-19550399.091100.11
4192971-19297197.80798.78
5193799-19379998.22799.26
6196485-19648599.589100.60
盐酸鲁拉西酮片项目信息
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%
111.021961821961761962461960351959791961240.06
211.141965411970301967860.18
单位质量响应值RSD%判断
17797.1017664.810.53数据可信
供试品溶液-24052102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%
5min1114966-11496658.20466.677.1058.2066.677.10
2130859-13085966.25166.25
3142983-14298372.38972.39
4130861-13086166.25266.25
5136385-13638569.04869.05
6134034-13403467.85867.86
10min1151609-15160976.75679.753.1176.8579.863.11
2156046-15604679.00279.11
3165840-16584083.96184.08
4155056-15505678.50178.61
5160029-16002981.01981.13
6156599-15659979.28279.40
15min1164615-16461583.34085.432.3083.5785.682.30
2167111-16711184.60484.85
3175589-17558988.89689.16
4166464-16646484.27684.52
5170394-17039486.26686.52
6168299-16829985.20585.45
20min1174416-17441688.30288.771.7488.6789.161.75
2173719-17371987.94988.33
3180866-18086691.56891.98
4173559-17355987.86888.25
5176836-17683689.52889.92
6172681-17268187.42487.81
30min1182564-18256492.42792.641.1192.9493.171.12
2182071-18207192.17892.71
3186632-18663294.48795.05
4181274-18127491.77492.30
5183887-18388793.09793.64
6181445-18144591.86192.39
45min1189386-18938695.88195.881.0296.5596.571.02
2192057-19205797.23497.92
3191040-19104096.71997.44
4187313-18731394.83295.51
5189197-18919795.78696.48
6187336-18733694.84395.53
60min1192306-19230697.36097.440.3698.1898.290.37
2192462-19246297.43998.28
3193249-19324997.83798.72
4193255-19325597.84098.68
5192035-19203597.22298.08
6191509-19150996.95697.80
极限1195865-19586599.16198.840.37100.1599.860.37
2195485-19548598.96999.98
3195100-19510098.77499.82
4193929-19392998.18199.18
5195864-19586499.161100.18
6195182-19518298.81699.82
盐酸鲁拉西酮片项目信息
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%
111.021984741986011985491985311984351985180.04
211.141946871945201946040.07
单位质量响应值RSD%判断
18014.3417468.942.18数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-1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%
5min1130061-13006165.82267.852.5365.8267.852.53
2134969-13496968.30568.31
3131015-13101566.30466.30
4133998-13399867.81467.81
5139603-13960370.65170.65
6134783-13478368.21168.21
10min1152698-15269877.27879.211.6977.3979.321.69
2157169-15716979.54079.65
3154564-15456478.22278.33
4156851-15685179.37979.49
5160399-16039981.17581.29
6157370-15737079.64279.76
15min1162905-16290582.44383.401.1082.6883.651.11
2166340-16634084.18284.43
3162854-16285482.41782.66
4164484-16448483.24283.49
5167359-16735984.69784.95
6164887-16488783.44683.69
20min1169144-16914485.60186.030.8985.9886.410.89
2170260-17026086.16586.55
3167912-16791284.97785.36
4170298-17029886.18586.57
5172468-17246887.28387.68
6169840-16984085.95386.34
30min1174386-17438688.25488.800.8088.7789.330.81
2175826-17582688.98289.51
3173897-17389788.00688.53
4175913-17591389.02689.55
5177835-17783589.99990.54
6174952-17495288.54089.07
45min1179707-17970790.94690.930.7891.6191.600.78
2180052-18005291.12191.80
3178160-17816090.16490.83
4178318-17831890.24490.92
5182006-18200692.11092.80
6179808-17980890.99891.67
60min1182130-18213092.17392.240.7092.9993.070.70
2181848-18184892.03092.86
3180744-18074491.47192.29
4183614-18361492.92493.75
5183935-18393593.08693.93
6181311-18131191.75892.59
极限1184577-18457793.41193.660.6894.3894.640.68
2186306-18630694.28695.27
3183043-18304392.63593.60
4185308-18530893.78194.76
5186388-18638894.32895.33
6184772-18477293.51094.49
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