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%
114.321717841721961721141717271722871720220.15
214.401720681721341721010.03
单位质量响应值RSD%判断
12012.7111951.460.37数据可信
供试品溶液-2024051221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%
2min1105780-10578062.40065.222.3862.4065.222.38
2111410-11141065.72165.72
3113688-11368867.06567.07
4111179-11117965.58565.59
5111247-11124765.62565.63
6110022-11002264.90364.90
5min1165728-16572897.76496.750.9897.7696.750.98
2164588-16458897.09297.09
3162197-16219795.68195.68
4165877-16587797.85297.85
5162849-16284996.06696.07
6162853-16285396.06896.07
10min1172853-172853101.967100.731.00101.97100.731.00
2171280-171280101.039101.04
3167857-16785799.02099.02
4171772-171772101.329101.33
5170137-170137100.365100.36
6170645-170645100.665100.66
15min1175140-175140103.316101.471.47103.32101.471.47
2170793-170793100.752100.75
3167791-16779198.98198.98
4173103-173103102.115102.11
5173249-173249102.201102.20
6171998-171998101.463101.46
20min1173763-173763102.504101.031.21102.50101.041.21
2170884-170884100.806100.81
3168126-16812699.17999.18
4173346-173346102.258102.26
5170444-170444100.546100.55
6171068-171068100.914100.91
30min1173051-173051102.084101.081.13102.08101.081.13
2171515-171515101.178101.18
3168107-16810799.16799.17
4173520-173520102.361102.36
5171032-171032100.893100.89
6170853-170853100.787100.79
45min1175688-175688103.640101.331.48103.64101.331.48
2171442-171442101.135101.13
3168311-16831199.28899.29
4173456-173456102.323102.32
5170467-170467100.560100.56
6171281-171281101.040101.04
60min1173483-173483102.339101.191.14102.34101.201.14
2171047-171047100.902100.90
3168411-16841199.34799.35
4173240-173240102.195102.20
5170453-170453100.551100.55
6172617-172617101.828101.83
极限1173907-173907102.589101.001.20102.59101.001.20
2171486-171486101.161101.16
3168245-16824599.24999.25
4172971-172971102.037102.04
5170604-170604100.640100.64
6170046-170046100.311100.31
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%
114.321734031735181728681735121735961733790.17
214.401736461738261737360.08
单位质量响应值RSD%判断
12107.4712065.000.25数据可信
供试品溶液-2024051221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%
2min1109214-10921463.87167.796.5463.8767.806.54
2112027-11202765.51665.52
3114117-11411766.73866.74
4124639-12463972.89272.89
5126159-12615973.78073.78
6109388-10938863.97263.97
5min1164843-16484396.40495.851.3796.4095.841.37
2166024-16602497.09497.09
3161317-16131794.34294.34
4166638-16663897.45397.45
5162337-16233794.93894.94
6162170-16217094.84094.84
10min1170896-17089699.944100.210.7299.94100.210.72
2172700-172700100.999101.00
3171092-171092100.058100.06
4172762-172762101.035101.03
5169517-16951799.13799.14
6171118-171118100.073100.07
15min1170865-17086599.925100.331.0199.93100.331.01
2173940-173940101.724101.72
3170792-17079299.88399.88
4173501-173501101.467101.47
5169735-16973599.26599.26
6170503-17050399.71499.71
20min1170776-17077699.873100.450.8599.87100.460.85
2173158-173158101.266101.27
3171396-171396100.236100.24
4173772-173772101.626101.63
5169951-16995199.39199.39
6171555-171555100.329100.33
30min1169671-16967199.227100.320.8599.23100.320.85
2173083-173083101.223101.22
3172319-172319100.776100.78
4173009-173009101.179101.18
5170575-17057599.75699.76
6170581-17058199.75999.76
45min1170497-17049799.710100.150.9499.71100.150.94
2174029-174029101.776101.78
3172222-172222100.719100.72
4170393-17039399.64999.65
5170646-17064699.79799.80
6169678-16967899.23199.23
60min1170676-17067699.815100.190.6499.81100.190.64
2171213-171213100.129100.13
3171805-171805100.475100.48
4173229-173229101.308101.31
5170244-17024499.56299.56
6170716-17071699.83899.84
极限1171011-171011100.011100.261.52100.01100.261.52
2174611-174611102.116102.12
3171695-171695100.411100.41
4172725-172725101.013101.01
5166781-16678197.53797.54
6171771-171771100.455100.46
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