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%
114.151812251814471808901811091806611810660.17
214.181809391810721810060.06
单位质量响应值RSD%判断
12796.1812764.880.18数据可信
供试品溶液-2733947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%
2min16021-60213.3307.5951.063.337.5951.05
210622-106225.8745.87
321590-2159011.94011.94
48225-82254.5494.55
513032-130327.2077.21
622897-2289712.66312.66
5min1131209-13120972.56579.108.1872.5779.108.18
2145811-14581180.64180.64
3151873-15187383.99383.99
4125683-12568369.50969.51
5153071-15307184.65684.66
6150497-15049783.23283.23
10min1175371-17537196.98997.081.9496.9997.081.93
2180806-18080699.99599.99
3175569-17556997.09897.10
4170168-17016894.11194.11
5176247-17624797.47397.47
6175008-17500896.78896.79
15min1182185-182185100.75799.041.18100.7699.041.18
2176424-17642497.57197.57
3177264-17726498.03698.04
4180509-18050999.83199.83
5178996-17899698.99498.99
6179046-17904699.02199.02
20min1182128-182128100.72699.841.86100.7399.841.87
2185454-185454102.565102.57
3176212-17621297.45497.45
4181155-181155100.188100.19
5177307-17730798.06098.06
6180849-180849100.019100.02
30min1181211-181211100.219100.421.43100.22100.421.43
2186322-186322103.045103.05
3179794-17979499.43599.44
4182607-182607100.991100.99
5179785-17978599.43099.43
6179738-17973899.40499.40
45min1183442-183442101.453100.781.37101.45100.781.37
2186184-186184102.969102.97
3179129-17912999.06799.07
4182906-182906101.156101.16
5180766-18076699.97399.97
6180969-180969100.085100.08
60min1183197-183197101.31799.991.20101.3299.991.20
2183674-183674101.581101.58
3178860-17886098.91998.92
4180725-18072599.95099.95
5178916-17891698.95098.95
6179387-17938799.21099.21
极限1182157-182157100.742100.271.16100.74100.271.16
2184888-184888102.252102.25
3179847-17984799.46499.46
4181669-181669100.472100.47
5180139-18013999.62699.63
6179113-17911399.05899.06
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%
114.151811551806731812431812681807861810250.16
214.181813701812861813280.04
单位质量响应值RSD%判断
12793.2912787.590.04数据可信
供试品溶液-2733947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%
2min143860-4386024.23814.3363.4424.2414.3463.43
225010-2501013.82113.82
38577-85774.7404.74
426868-2686814.84814.85
56565-65653.6283.63
644754-4475424.73224.73
5min1161523-16152389.26179.3210.2089.2679.3210.20
2145718-14571880.52780.53
3134413-13441374.27974.28
4128502-12850271.01371.01
5130948-13094872.36572.36
6160083-16008388.46588.47
10min1177622-17762298.15896.541.7198.1696.541.71
2174339-17433996.34396.34
3172141-17214195.12995.13
4171527-17152794.78994.79
5173589-17358995.92995.93
6178900-17890098.86498.86
15min1181602-181602100.35798.511.48100.3698.521.48
2177657-17765798.17798.18
3174659-17465996.52096.52
4176809-17680997.70897.71
5177839-17783998.27898.28
6181043-181043100.048100.05
20min1182696-182696100.96298.711.44100.9698.711.43
2177347-17734798.00698.01
3177059-17705997.84797.85
4176621-17662197.60497.60
5177043-17704397.83897.84
6180959-180959100.002100.00
30min1181482-181482100.29199.130.87100.2999.130.87
2178513-17851398.65098.65
3178846-17884698.83498.83
4177449-17744998.06298.06
5179020-17902098.93098.93
6181025-181025100.038100.04
45min1183095-183095101.18298.831.36101.1898.841.35
2176140-17614097.33997.34
3178184-17818498.46898.47
4177894-17789498.30898.31
5177765-17776598.23798.24
6179989-17998999.46699.47
60min1180081-18008199.51798.821.2999.5298.821.29
2180098-18009899.52699.53
3179232-17923299.04799.05
4174577-17457796.47596.47
5178049-17804998.39498.39
6180918-18091899.97999.98
极限1181910-181910100.52799.130.97100.5399.130.97
2177801-17780198.25798.26
3178220-17822098.48898.49
4178816-17881698.81798.82
5178295-17829598.53098.53
6181217-181217100.144100.14
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