氢溴酸伏硫西汀口崩片项目信息
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%
113.891786251790991785171784791782111785860.19
213.891788471795581792020.29
单位质量响应值RSD%判断
12857.1612901.510.25数据可信
供试品溶液-BY批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min146340-4634025.43236.2141.0725.4336.2141.08
2103947-10394757.04757.05
330618-3061816.80316.80
472836-7283639.97339.97
555350-5535030.37730.38
686813-8681347.64447.64
5min1156606-15660685.94786.092.9685.9586.092.96
2162237-16223789.03789.04
3162668-16266889.27489.27
4153401-15340184.18884.19
5151509-15150983.14983.15
6154760-15476084.93484.93
10min1172723-17272394.79292.351.9694.7992.361.96
2169038-16903892.76992.77
3171318-17131894.02194.02
4166389-16638991.31691.32
5164447-16444790.25090.25
6165777-16577790.98090.98
15min1173673-17367395.31393.182.0895.3193.182.08
2170914-17091493.79993.80
3173617-17361795.28295.28
4167023-16702391.66491.66
5168393-16839392.41592.42
6165141-16514190.63190.63
20min1174823-17482395.94493.841.6395.9493.841.63
2168459-16845992.45292.45
3174149-17414995.57495.57
4169042-16904292.77292.77
5169221-16922192.87092.87
6170198-17019893.40693.41
30min1171299-17129994.01093.531.5094.0193.531.50
2170831-17083193.75393.75
3173967-17396795.47495.47
4168140-16814092.27792.28
5166843-16684391.56591.56
6171495-17149594.11894.12
45min1174425-17442595.72694.791.5695.7394.791.56
2169845-16984593.21293.21
3176595-17659596.91796.92
4169654-16965493.10793.11
5172530-17253094.68694.69
6173278-17327895.09695.10
60min1178475-17847597.94995.251.9797.9595.251.97
2173304-17330495.11195.11
3174571-17457195.80695.81
4173991-17399195.48895.49
5167839-16783992.11192.11
6173144-17314495.02395.02
极限1178135-17813597.76295.002.5697.7694.992.56
2172270-17227094.54394.54
3178976-17897698.22398.22
4170613-17061393.63493.63
5168248-16824892.33692.34
6170320-17032093.47393.47
氢溴酸伏硫西汀口崩片项目信息
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%
113.891785241788851785011787611786121786570.10
213.891787821792881790350.20
单位质量响应值RSD%判断
12862.2812889.490.15数据可信
供试品溶液-BY批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min124327-2432713.35413.6328.3413.3513.6328.32
227154-2715414.90614.91
333246-3324618.25118.25
414003-140037.6877.69
519959-1995910.95710.96
630318-3031816.64316.64
5min1114928-11492863.09065.714.2663.0965.724.26
2125782-12578269.04969.05
3126000-12600069.16869.17
4115361-11536163.32863.33
5116297-11629763.84263.84
6119874-11987465.80565.81
10min1154434-15443484.77784.205.7184.7884.205.71
2154526-15452684.82884.83
3157790-15779086.62086.62
4165024-16502490.59190.59
5149621-14962182.13582.14
6138849-13884976.22276.22
15min1163270-16327089.62888.794.8389.6388.794.83
2166386-16638691.33891.34
3163875-16387589.96089.96
4169904-16990493.27093.27
5159605-15960587.61687.62
6147434-14743480.93580.93
20min1178366-17836697.91592.824.1397.9192.824.13
2171431-17143194.10894.11
3172588-17258894.74394.74
4169904-16990493.27093.27
5163633-16363389.82789.83
6158636-15863687.08487.08
30min1190566-190566104.61296.635.34104.6196.635.34
2176852-17685297.08497.08
3180454-18045499.06199.06
4176045-17604596.64196.64
5168601-16860192.55492.55
6163627-16362789.82489.82
45min1190985-190985104.84296.784.64104.8496.784.64
2178061-17806197.74797.75
3177065-17706597.20197.20
4173404-17340495.19195.19
5170603-17060393.65393.65
6167723-16772392.07292.07
60min1190733-190733104.70497.274.92104.7097.274.91
2181767-18176799.78299.78
3178096-17809697.76797.77
4176703-17670397.00297.00
5168706-16870692.61292.61
6167127-16712791.74591.75
极限1191388-191388105.06395.985.82105.0695.985.82
2180039-18003998.83398.83
3177413-17741397.39297.39
4164665-16466590.39490.39
5169517-16951793.05793.06
6166035-16603591.14691.15
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