盐酸鲁拉西酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
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500
标示量(mg)20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%
111.091913831916551914791913551917901915320.10
211.081929501927621928560.07
单位质量响应值RSD%判断
17270.6917405.780.56数据可信
加速6月-供试品溶液-2025011721批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min179286-7928641.05041.442.2241.0541.442.22
281914-8191442.41042.41
376856-7685639.79239.79
480510-8051041.68341.68
581039-8103941.95741.96
680583-8058341.72141.72
10min1107845-10784555.83655.071.9556.2955.531.95
2109010-10901056.43956.91
3103215-10321553.43953.88
4104934-10493454.32954.79
5106424-10642455.10055.57
6106797-10679755.29355.76
15min1120416-12041662.34461.911.3863.4262.981.38
2120734-12073462.50963.61
3117534-11753460.85261.89
4118514-11851461.36062.43
5118478-11847861.34162.42
6121809-12180963.06664.14
20min1131224-13122467.94067.681.1669.7169.441.16
2132120-13212068.40470.20
3129020-12902066.79968.51
4129158-12915866.87168.62
5130191-13019167.40569.17
6132592-13259268.64870.43
30min1145869-14586975.52374.871.2578.0577.381.25
2145834-14583475.50478.06
3142919-14291973.99576.45
4142134-14213473.58976.08
5144237-14423774.67877.19
6146615-14661575.90978.45
45min1157568-15756881.58081.611.4684.9484.951.45
2159778-15977882.72486.12
3155888-15588880.71083.99
4154771-15477180.13183.44
5156916-15691681.24284.58
6160788-16078883.24786.63
60min1166072-16607285.98286.041.0190.2590.291.02
2167723-16772386.83791.15
3165593-16559385.73489.91
4163457-16345784.62988.83
5166097-16609785.99590.24
6168144-16814487.05591.37
极限1173096-17309689.61989.451.3394.8494.661.32
2175192-17519290.70495.98
3171605-17160588.84793.97
4169319-16931987.66492.80
5172090-17209089.09894.30
6175326-17532690.77496.05
盐酸鲁拉西酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
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500
标示量(mg)20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%
111.091924331931141933131929661924351928520.21
211.081932251932011932130.01
单位质量响应值RSD%判断
17389.7217438.000.20数据可信
中间条件6月-供试品溶液-2025011721批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min181479-8147942.00142.413.9042.0042.413.90
282770-8277042.66742.67
385852-8585244.25644.26
484625-8462543.62343.62
576599-7659939.48639.49
682294-8229442.42142.42
10min1107584-10758455.45856.022.7155.9256.482.72
2109779-10977956.59057.06
3111802-11180257.63258.12
4111099-11109957.27057.75
5103696-10369653.45453.89
6108050-10805055.69856.17
15min1125468-12546864.67764.132.3965.7665.222.39
2125053-12505364.46365.57
3127584-12758465.76866.90
4126642-12664265.28266.40
5119857-11985761.78562.82
6121838-12183862.80663.90
20min1135254-13525469.72269.662.0571.5271.472.07
2135797-13579770.00271.82
3137372-13737270.81372.68
4138511-13851171.40173.25
5131177-13117767.62069.34
6132744-13274468.42870.22
30min1149655-14965577.14577.561.1179.7280.141.15
2151417-15141778.05380.65
3152437-15243778.57981.23
4151857-15185778.28080.92
5148627-14862776.61579.09
6148733-14873376.67079.22
45min1162768-16276883.90584.091.0687.3487.531.08
2163797-16379784.43587.90
3164644-16464484.87288.39
4165034-16503485.07388.58
5162075-16207583.54886.87
6160458-16045882.71486.11
60min1170989-17098988.14388.341.0292.5192.721.01
2174149-17414989.77294.17
3170168-17016887.71992.19
4172818-17281889.08593.54
5170453-17045387.86692.12
6169667-16966787.46191.78
极限1177626-17762691.56492.100.8696.9197.460.81
2179846-17984692.70898.11
3176940-17694091.21096.65
4180258-18025892.92198.37
5180004-18000492.79098.02
6177338-17733891.41596.71
盐酸鲁拉西酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
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500
标示量(mg)20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%
111.091927761928171927031926001929131927620.07
211.081928131935031931580.26
单位质量响应值RSD%判断
17381.6117433.030.21数据可信
长期6月-供试品溶液-2025011721批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min183721-8372143.17343.024.4443.1743.024.44
276037-7603739.21139.21
385947-8594744.32144.32
484570-8457043.61143.61
585358-8535844.01744.02
684918-8491843.79143.79
10min1109899-10989956.67356.024.3157.1556.504.30
2102449-10244952.83153.27
3111109-11110957.29757.79
4103087-10308753.16053.64
5112288-11228857.90558.39
6113022-11302258.28358.77
15min1124530-12453064.21864.473.1865.3365.563.18
2117413-11741360.54861.57
3125488-12548864.71265.84
4127936-12793665.97467.05
5126591-12659165.28166.41
6128103-12810366.06067.19
20min1133909-13390969.05469.832.6870.8871.652.69
2128792-12879266.41668.11
3137177-13717770.74072.59
4138310-13831071.32473.13
5138124-13812471.22873.09
6136187-13618770.22972.10
30min1147500-14750076.06377.051.9978.6579.642.01
2145015-14501574.78177.21
3148588-14858876.62479.26
4151794-15179478.27780.88
5153042-15304278.92181.57
6150568-15056877.64580.29
45min1160415-16041582.72383.510.9386.1686.960.98
2159970-15997082.49385.76
3162219-16221983.65387.14
4163215-16321584.16787.64
5163774-16377484.45587.98
6162042-16204283.56287.07
60min1166305-16630585.76087.321.4790.1191.701.47
2166711-16671185.97090.15
3169729-16972987.52691.94
4172952-17295289.18893.59
5170010-17001087.67192.14
6170291-17029187.81692.26
极限1173810-17381089.63090.271.0294.9495.611.05
2172810-17281089.11594.25
3176673-17667391.10796.49
4177394-17739491.47996.88
5175477-17547790.49095.93
6174084-17408489.77295.19
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