氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.161802681804081800651796111801421800990.17
214.071806891809151808020.09
单位质量响应值RSD%判断
12718.8612850.180.73数据可信
供试品溶液-24050602批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1127096-12709670.27069.795.8870.2769.795.88
2121644-12164467.25667.26
3140692-14069277.78777.79
4120753-12075366.76366.76
5123434-12343468.24668.25
6123768-12376868.43068.43
5min1173816-17381696.10196.110.9696.1096.100.96
2172425-17242595.33295.33
3174282-17428296.35996.36
4174345-17434596.39496.39
5176405-17640597.53397.53
6171679-17167994.92094.92
10min1175403-17540396.97997.491.2496.9897.491.24
2174284-17428496.36096.36
3177658-17765898.22698.23
4178444-17844498.66098.66
5178571-17857198.73098.73
6173622-17362295.99495.99
15min1175206-17520696.87097.421.2696.8797.421.25
2173754-17375496.06796.07
3177750-17775098.27698.28
4178452-17845298.66598.66
5178214-17821498.53398.53
6173798-17379896.09196.09
20min1174766-17476696.62797.421.3096.6397.421.30
2174360-17436096.40296.40
3177645-17764598.21898.22
4178820-17882098.86898.87
5178210-17821098.53198.53
6173458-17345895.90395.90
30min1175106-17510696.81597.391.3596.8197.391.35
2173652-17365296.01196.01
3178046-17804698.44098.44
4178632-17863298.76498.76
5178038-17803898.43698.44
6173427-17342795.88695.89
45min1175514-17551497.04097.611.3597.0497.611.34
2174119-17411996.26996.27
3178238-17823898.54698.55
4179337-17933799.15499.15
5178248-17824898.55298.55
6173810-17381096.09896.10
60min1175932-17593297.27197.721.4197.2797.721.41
2173796-17379696.09096.09
3178341-17834198.60398.60
4179921-17992199.47799.48
5178296-17829698.57898.58
6174219-17421996.32496.32
极限1177836-17783698.32498.541.3298.3298.531.32
2175029-17502996.77296.77
3179171-17917199.06299.06
4180836-18083699.98399.98
5180387-18038799.73499.73
6176065-17606597.34597.34
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.161802521802931801651799271799131801100.10
214.071800031800511800270.02
单位质量响应值RSD%判断
12719.6312795.100.42数据可信
供试品溶液-24050603批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1133337-13333773.87672.313.2473.8872.313.24
2136382-13638275.56475.56
3125343-12534369.44769.45
4132576-13257673.45573.45
5128185-12818571.02271.02
6127275-12727570.51870.52
5min1176513-17651397.79995.992.2497.8095.992.24
2179330-17933099.35999.36
3170339-17033994.37894.38
4172274-17227495.45095.45
5169354-16935493.83293.83
6171674-17167495.11795.12
10min1183242-183242101.52799.432.28101.5399.432.28
2185473-185473102.763102.76
3175921-17592197.47197.47
4178319-17831998.79998.80
5175180-17518097.06097.06
6178639-17863998.97698.98
15min1184024-184024101.96099.822.29101.9699.822.29
2186133-186133103.129103.13
3176552-17655297.82097.82
4179347-17934799.36999.37
5175732-17573297.36697.37
6179160-17916099.26599.27
20min1184152-184152102.03199.912.29102.0399.912.29
2186312-186312103.228103.23
3176582-17658297.83797.84
4179378-17937899.38699.39
5175980-17598097.50397.50
6179538-17953899.47599.47
30min1183779-183779101.82499.942.09101.8299.942.09
2185882-185882102.989102.99
3176274-17627497.66697.67
4179751-17975199.59399.59
5177071-17707198.10898.11
6179503-17950399.45599.46
45min1184706-184706102.338100.222.23102.34100.222.23
2186704-186704103.445103.44
3176423-17642397.74997.75
4179738-17973899.58599.59
5177606-17760698.40498.40
6180123-18012399.79999.80
60min1184588-184588102.273100.242.27102.27100.232.27
2186971-186971103.593103.59
3176413-17641397.74397.74
4179424-17942499.41199.41
5177532-17753298.36398.36
6180541-180541100.030100.03
极限1184435-184435102.188100.182.22102.19100.182.22
2186862-186862103.532103.53
3176535-17653597.81197.81
4179116-17911699.24199.24
5177898-17789898.56698.57
6179982-17998299.72199.72
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.161810651807691807201807911808191808330.08
214.071801411801011801210.02
单位质量响应值RSD%判断
12770.6912801.780.18数据可信
供试品溶液-24050603批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1131651-13165172.77771.222.1372.7871.232.14
2129325-12932571.49171.49
3125465-12546569.35769.36
4125421-12542169.33369.33
5130927-13092772.37772.38
6130273-13027372.01572.02
5min1173678-17367896.01096.090.5696.0196.090.56
2172606-17260695.41795.42
3174819-17481996.64196.64
4172768-17276895.50795.51
5174797-17479796.62896.63
6174242-17424296.32296.32
10min1180733-18073399.91099.830.6499.9199.830.63
2178638-17863898.75298.75
3181842-181842100.523100.52
4180305-18030599.67399.67
5181574-181574100.375100.37
6180417-18041799.73599.74
15min1181411-181411100.285100.501.27100.28100.501.27
2179164-17916499.04299.04
3182323-182323100.789100.79
4181160-181160100.146100.15
5185996-185996102.819102.82
6180739-18073999.91399.91
20min1181356-181356100.254100.420.86100.25100.420.86
2179258-17925899.09499.09
3183666-183666101.531101.53
4181516-181516100.343100.34
5183032-183032101.181101.18
6181086-181086100.105100.10
30min1181412-181412100.285100.430.82100.29100.430.82
2179672-17967299.32399.32
3182958-182958101.140101.14
4181681-181681100.434100.43
5183710-183710101.556101.56
6180649-18064999.86399.86
45min1180989-180989100.051100.480.70100.05100.480.70
2180582-18058299.82699.83
3182444-182444100.856100.86
4181345-181345100.248100.25
5184027-184027101.731101.73
6181243-181243100.192100.19
60min1181209-181209100.173100.640.85100.17100.640.85
2181478-181478100.322100.32
3183137-183137101.239101.24
4181546-181546100.359100.36
5184582-184582102.038102.04
6180368-18036899.70899.71
极限1182492-182492100.882100.730.57100.88100.730.57
2181064-181064100.093100.09
3182550-182550100.914100.91
4181670-181670100.428100.43
5183948-183948101.687101.69
6181571-181571100.373100.37
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