盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.912421712422122420392421962415742420380.12
29.992424432423692424060.03
单位质量响应值RSD%判断
24423.6124264.860.47数据可信
供试品溶液-2095120批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1119502-11950287.91889.521.8687.9289.521.86
2121984-12198489.74489.74
3120160-12016088.40288.40
4124280-12428091.43391.43
5124462-12446291.56791.57
6119719-11971988.07888.08
10min1124830-12483091.83893.131.5591.9893.281.56
2126683-12668393.20193.35
3125479-12547992.31692.46
4128987-12898794.89695.05
5128895-12889594.82994.98
6124628-12462891.69091.84
15min1126297-12629792.91794.111.7093.2294.421.70
2127622-12762293.89294.20
3126962-12696293.40793.71
4130519-13051996.02496.33
5130627-13062796.10396.41
6125495-12549592.32792.63
20min1127297-12729793.65394.471.6094.1194.941.60
2128365-12836594.43994.90
3127295-12729593.65294.11
4130867-13086796.28096.75
5130816-13081696.24296.71
6125835-12583592.57893.03
30min1127237-12723793.60994.411.5594.2295.031.55
2127894-12789494.09294.71
3127148-12714893.54394.16
4130790-13079096.22396.85
5130781-13078196.21696.85
6126146-12614692.80693.41
45min1126998-12699893.43394.662.0194.2095.442.00
2128045-12804594.20394.98
3127410-12741093.73694.51
4131585-13158596.80897.60
5132136-13213697.21398.00
6125852-12585292.59093.35
60min1128146-12814694.27894.901.7495.2095.841.74
2128566-12856694.58795.52
3127551-12755193.84094.77
4131430-13143096.69497.65
5131978-13197897.09798.05
6126289-12628992.91293.83
极限1127747-12774793.98494.911.6895.0696.001.68
2128397-12839794.46295.55
3128063-12806394.21795.30
4131412-13141296.68197.79
5131900-13190097.04098.16
6126493-12649393.06294.13
盐酸司来吉兰片项目信息
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101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.912423462421262421832420382421962421780.05
29.992415622415972415800.02
单位质量响应值RSD%判断
24437.7424182.180.75数据可信
供试品溶液-2180621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1128210-12821094.45992.881.1794.4692.881.17
2125751-12575192.64892.65
3125535-12553592.48992.49
4125988-12598892.82292.82
5127057-12705793.61093.61
6123859-12385991.25491.25
10min1133007-13300797.99496.011.5298.1596.171.52
2130393-13039396.06896.22
3128271-12827194.50494.66
4129643-12964395.51595.67
5132245-13224597.43297.59
6128352-12835294.56494.72
15min1133558-13355898.40096.701.4798.7297.011.47
2131937-13193797.20597.52
3129041-12904195.07295.38
4130438-13043896.10196.41
5133170-13317098.11498.43
6129365-12936595.31095.62
20min1133552-13355298.39596.741.4698.8897.221.46
2131966-13196697.22797.70
3129116-12911695.12795.60
4130886-13088696.43196.91
5133135-13313598.08898.57
6129207-12920795.19495.66
30min1133394-13339498.27996.581.4598.9397.221.45
2131711-13171197.03997.68
3128877-12887794.95195.58
4130751-13075196.33296.97
5132807-13280797.84698.49
6129013-12901395.05195.68
45min1133110-13311098.07096.471.4398.8897.271.43
2131646-13164696.99197.79
3128457-12845794.64195.43
4130664-13066496.26797.06
5132633-13263397.71898.53
6129160-12916095.15995.94
60min1133385-13338598.27296.401.5299.2597.361.52
2131498-13149896.88297.84
3128187-12818794.44295.39
4130484-13048496.13597.09
5132424-13242497.56498.54
6129089-12908995.10796.05
极限1132773-13277397.82196.151.4998.9697.271.49
2131299-13129996.73597.86
3127977-12797794.28895.39
4130162-13016295.89897.01
5132195-13219597.39598.53
6128595-12859594.74395.85
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