氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能对照品使用方法直接使用
对照品含量(%)100.4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%
114.221801961805361805861804771805001804590.09
214.201817621812241814930.21
单位质量响应值RSD%判断
12690.5112781.200.51数据可信
供试品溶液-24022602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%
5min176898-7689842.92243.543.3842.9243.543.38
278392-7839243.75643.76
375468-7546842.12442.12
478669-7866943.91043.91
582681-8268146.15046.15
675881-7588142.35442.35
10min1111563-11156362.27162.072.9162.3462.142.91
2112677-11267762.89262.97
3108070-10807060.32160.39
4116767-11676765.17565.25
5108893-10889360.78060.86
6109249-10924960.97961.05
15min1125367-12536769.97669.012.5070.1569.192.50
2125444-12544470.01870.20
3121387-12138767.75467.92
4127481-12748171.15571.34
5123149-12314968.73868.92
6119042-11904266.44566.62
20min1131766-13176673.54772.641.7473.8472.931.73
2130757-13075772.98473.28
3128218-12821871.56771.85
4133115-13311574.30074.60
5127014-12701470.89571.19
6129982-12998272.55172.83
30min1139826-13982678.04675.733.3578.4676.143.34
2138827-13882777.48877.90
3135497-13549775.63076.03
4138538-13853877.32777.75
5127696-12769671.27571.69
6133634-13363474.59074.99
45min1144665-14466580.74780.001.3781.2980.541.37
2144843-14484380.84681.39
3140516-14051678.43178.96
4145084-14508480.98181.53
5143494-14349480.09380.62
6141351-14135178.89779.43
60min1146493-14649381.76780.892.2782.4581.562.27
2149410-14941083.39584.08
3141638-14163879.05779.72
4147440-14744082.29682.98
5142558-14255879.57180.23
6142002-14200279.26179.92
90min1147127-14712782.12181.692.3282.9482.502.31
2149306-14930683.33784.16
3140923-14092378.65879.45
4150299-15029983.89284.72
5144816-14481680.83181.63
6145685-14568581.31682.11
120min1150148-15014883.80781.763.0484.7682.703.01
2145612-14561281.27682.23
3146681-14668181.87282.79
4151102-15110284.34085.30
5138546-13854677.33278.26
6146792-14679281.93482.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1151554-15155484.59284.081.5185.6885.151.51
2154185-15418586.06187.15
3148105-14810582.66783.73
4151640-15164084.64085.75
5149614-14961483.50984.57
6148667-14866782.98184.04
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能对照品使用方法直接使用
对照品含量(%)100.4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%
114.221810131806701804581810971805861807650.16
214.201803921804951804440.05
单位质量响应值RSD%判断
12712.0312707.320.03数据可信
供试品溶液-24022901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%
5min184912-8491247.49250.383.0847.4950.383.08
290605-9060550.67650.68
391580-9158051.22151.22
489545-8954550.08350.08
592950-9295051.98851.99
690884-9088450.83250.83
10min1115401-11540164.54566.992.3864.6267.082.39
2119226-11922666.68466.77
3121334-12133467.86367.95
4120010-12001067.12367.21
5123955-12395569.32969.42
6118727-11872766.40566.49
15min1129621-12962172.49874.212.1572.6874.402.15
2130342-13034272.90173.10
3132178-13217873.92874.13
4133655-13365574.75474.95
5137610-13761076.96677.17
6132665-13266574.20174.40
20min1139708-13970878.14079.251.8878.4579.561.88
2139669-13966978.11878.44
3142517-14251779.71180.03
4142447-14244779.67279.99
5146292-14629281.82282.15
6139474-13947478.00978.33
30min1153187-15318785.67984.821.8086.1285.271.80
2148009-14800982.78383.23
3152902-15290285.51985.97
4151745-15174584.87285.32
5155181-15518186.79487.26
6148924-14892483.29483.74
45min1161713-16171390.44789.151.8091.0389.741.79
2158476-15847688.63789.22
3159147-15914789.01289.61
4158541-15854188.67389.27
5163361-16336191.36991.98
6155150-15515086.77787.36
60min1159456-15945689.18591.161.3689.9291.901.35
2165295-16529592.45193.18
3163209-16320991.28492.03
4161925-16192590.56691.31
5162716-16271691.00891.77
6165301-16530192.45493.19
90min1169025-16902594.53792.081.9695.4292.981.94
2162385-16238590.82391.71
3163682-16368291.54992.45
4166262-16626292.99293.88
5166367-16636793.05093.97
6160090-16009089.54090.43
120min1168645-16864594.32492.851.9295.3693.901.91
2166410-16641093.07494.11
3166188-16618892.95094.00
4167227-16722793.53194.58
5167790-16779093.84694.92
6159782-15978289.36790.40
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1168886-16888694.45992.931.4395.6594.131.42
2165674-16567492.66393.86
3165016-16501692.29593.50
4167883-16788393.89895.10
5167202-16720293.51794.74
6162286-16228690.76891.95
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