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对照品来源中检院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%
111.231990171991021990651991601991751991040.04
211.261987201984161985680.11
单位质量响应值RSD%判断
17729.6517634.810.38数据可信
长期24月-供试品溶液-2022082601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%
5min161918-6191831.43431.504.2231.4331.504.23
263578-6357832.27632.28
358317-5831729.60629.61
465571-6557133.28833.29
559891-5989130.40530.40
663014-6301431.99031.99
10min1120941-12094161.39863.882.3361.4563.932.33
2124871-12487163.39363.45
3124715-12471563.31463.36
4128631-12863165.30265.36
5127506-12750664.73064.78
6128298-12829865.13365.19
15min1145728-14572873.98175.381.1074.1475.541.10
2147572-14757274.91775.08
3148471-14847175.37475.53
4150006-15000676.15376.32
5149861-14986176.07976.24
6149282-14928275.78575.95
20min1159573-15957381.01081.340.5981.2981.620.60
2158885-15888580.66080.94
3160125-16012581.29081.57
4160449-16044981.45481.75
5161625-16162582.05182.34
6160653-16065381.55881.85
30min1173988-17398888.32888.520.4888.7488.940.48
2172899-17289987.77588.19
3174831-17483188.75689.17
4174896-17489688.78989.22
5175136-17513688.91189.33
6174440-17444088.55788.98
45min1185170-18517094.00494.050.4894.5694.620.48
2184003-18400393.41293.98
3185755-18575594.30194.87
4185833-18583394.34194.92
5186324-18632494.59095.16
6184508-18450893.66894.24
60min1190577-19057796.74996.750.3297.4797.480.32
2189559-18955996.23396.95
3191204-19120497.06897.79
4190749-19074996.83797.57
5191052-19105296.99197.72
6190328-19032896.62397.35
极限1195330-19533099.16298.840.44100.0499.720.44
2193617-19361798.29399.17
3193748-19374898.35999.24
4195509-19550999.253100.15
5195354-19535499.175100.06
6194607-19460798.79599.68
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对照品来源中检院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%
111.232001282000751997751992531988401996140.28
211.262020542020702020620.01
单位质量响应值RSD%判断
17775.0717945.120.68数据可信
长期24月-供试品溶液-2022082601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%
5min163255-6325531.79329.357.6531.7929.347.65
251015-5101525.64125.64
355484-5548427.88727.89
461687-6168731.00531.00
559609-5960929.96129.96
659279-5927929.79529.79
10min1130831-13083165.75863.253.1165.8163.303.11
2120457-12045760.54460.59
3123220-12322061.93361.98
4129565-12956565.12265.17
5124630-12463062.64162.69
6126386-12638663.52463.57
15min1153329-15332977.06675.461.1277.2375.611.13
2148759-14875974.76974.91
3149917-14991775.35175.50
4150253-15025375.52075.68
5149699-14969975.24175.40
6148837-14883774.80874.96
20min1165243-16524383.05481.571.0183.3581.851.02
2161365-16136581.10581.37
3162217-16221781.53381.81
4162261-16226181.55581.84
5162324-16232481.58781.87
6160365-16036580.60280.88
30min1177268-17726889.09888.550.6289.5388.970.62
2176387-17638788.65589.06
3176782-17678288.85489.26
4175480-17548088.19988.62
5176857-17685788.89289.31
6174341-17434187.62788.04
45min1186982-18698293.98193.970.7094.5694.530.70
2187428-18742894.20594.76
3187841-18784194.41294.97
4186551-18655193.76494.33
5188294-18829494.64095.20
6184622-18462292.79493.35
60min1191635-19163596.31996.620.8497.0597.340.83
2193812-19381297.41398.12
3192979-19297996.99597.71
4192041-19204196.52397.25
5193530-19353097.27297.99
6189462-18946295.22795.94
极限1194513-19451397.76698.590.8598.6699.470.84
2196975-19697599.00399.87
3196838-19683898.93499.81
4196361-19636198.69599.58
5198336-19833699.687100.57
6193878-19387897.44798.32
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对照品来源中检院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%
111.232001401998421998771998371992621997920.17
211.262012302008402010350.14
单位质量响应值RSD%判断
17790.9217853.910.25数据可信
长期24月-供试品溶液-2022082701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%
5min161916-6191631.18530.1024.7931.1930.1024.78
230310-3031015.26615.27
370270-7027035.39335.39
461707-6170731.08031.08
567481-6748133.98833.99
666914-6691433.70333.70
10min1131560-13156066.26367.258.7666.3167.308.77
2111003-11100355.90955.93
3142380-14238071.71371.77
4135942-13594268.47068.52
5140005-14000570.51670.57
6140254-14025470.64270.70
15min1153357-15335777.24178.505.1477.4078.665.16
2140791-14079170.91271.03
3162087-16208781.63881.82
4157804-15780479.48179.65
5160046-16004680.61080.78
6161033-16103381.10881.28
20min1164643-16464382.92684.343.7583.2284.643.77
2156019-15601978.58278.82
3172919-17291987.09487.41
4169352-16935285.29885.60
5170265-17026585.75886.07
6171496-17149686.37886.69
30min1178470-17847089.89090.812.0890.3291.252.11
2173716-17371687.49687.86
3184271-18427192.81293.27
4181126-18112691.22891.67
5182220-18222091.77992.23
6182030-18203091.68392.14
45min1187501-18750194.43995.230.9295.0295.810.94
2186808-18680894.09094.60
3191170-19117096.28796.90
4190801-19080196.10196.69
5189016-18901695.20295.81
6189081-18908195.23595.84
60min1193342-19334297.38197.210.6598.1297.950.64
2193211-19321197.31597.99
3194599-19459998.01498.79
4193530-19353097.47598.23
5190945-19094596.17396.94
6192338-19233896.87597.64
极限1196770-19677099.10798.800.80100.0199.710.76
2198435-19843599.946100.78
3196204-19620498.82299.76
4196764-19676499.104100.02
5194317-19431797.87298.80
6194502-19450297.96598.89
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对照品来源中检院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%
111.232003992002761999082000441999132001080.12
211.262012942006092009520.25
单位质量响应值RSD%判断
17819.0617846.540.11数据可信
长期24月-供试品溶液-2022082701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%
5min161383-6138330.89931.953.8430.9031.953.84
266408-6640833.42833.43
360228-6022830.31730.32
464502-6450232.46932.47
562723-6272331.57331.57
665597-6559733.02033.02
10min1135834-13583468.37667.503.5068.4367.553.51
2132848-13284866.87366.93
3125898-12589863.37463.42
4134710-13471067.81067.86
5135057-13505767.98468.04
6140179-14017970.56370.62
15min1156807-15680778.93378.822.3179.1078.982.31
2152054-15205476.54076.71
3152379-15237976.70476.86
4158866-15886679.96980.14
5158574-15857479.82279.99
6160772-16077280.92981.10
20min1166591-16659183.85884.512.3984.1584.812.39
2162296-16229681.69681.99
3164602-16460282.85783.14
4170805-17080585.97986.28
5170606-17060685.87986.18
6172446-17244686.80587.11
30min1179031-17903190.12090.471.7890.5690.911.79
2174867-17486788.02488.45
3177360-17736089.27989.70
4182565-18256591.89992.34
5182572-18257291.90292.34
6182020-18202091.62592.08
45min1187822-18782294.54594.721.6295.1395.311.62
2182846-18284692.04092.62
3187969-18796994.61995.19
4190335-19033595.81096.41
5191755-19175596.52597.12
6188270-18827094.77195.38
60min1192491-19249196.89597.011.4897.6497.751.48
2187521-18752194.39495.12
3193111-19311197.20797.94
4195270-19527098.29499.05
5195342-19534298.33199.09
6192537-19253796.91997.68
极限1195019-19501998.16898.461.2999.0799.371.29
2191408-19140896.35097.24
3197442-19744299.388100.28
4196944-19694499.137100.06
5198315-19831599.827100.75
6194446-19444697.87998.80
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