托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.511976081980641976491980791980741978950.13
216.492002572007112004840.17
单位质量响应值RSD%判断
11986.3712157.911.01数据可信
供试品溶液-2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%
5min116623-166238.26210.5213.768.2610.5213.75
222219-2221911.04411.04
320319-2031910.09910.10
420519-2051910.19910.20
521796-2179610.83310.83
625540-2554012.69412.69
10min149658-4965824.68224.394.8424.7024.414.85
249451-4945124.57924.60
348890-4889024.30024.32
447826-4782623.77123.79
545671-4567122.70022.72
652883-5288326.28526.31
15min169316-6931634.45334.073.7734.5134.133.76
269553-6955334.57034.63
368601-6860134.09734.15
465969-6596932.78932.85
565391-6539132.50232.56
672427-7242735.99936.06
20min185013-8501342.25541.633.3542.3741.753.36
284521-8452142.01042.13
382606-8260641.05841.17
482879-8287941.19441.31
579599-7959939.56439.67
687963-8796343.72143.85
30min1107950-10795053.65552.553.0853.8452.743.09
2107173-10717353.26953.46
3104146-10414651.76451.95
4105054-10505452.21652.40
5100447-10044749.92650.10
6109611-10961154.48154.68
45min1131296-13129665.25963.832.3265.5364.112.32
2128697-12869763.96764.24
3127834-12783463.53863.81
4126768-12676863.00863.28
5123969-12396961.61761.88
6132009-13200965.61365.90
60min1147766-14776673.44571.912.0373.8372.282.04
2145769-14576972.45372.83
3143147-14314771.14971.52
4143978-14397871.56271.93
5139980-13998069.57569.94
6147396-14739673.26173.66
90min1167847-16784783.42681.411.6883.9381.911.69
2164322-16432281.67482.18
3162171-16217180.60581.10
4162767-16276780.90181.39
5160058-16005879.55580.03
6165629-16562982.32482.84
120min1179416-17941689.17686.621.9389.8287.261.93
2175731-17573187.34587.98
3169831-16983184.41285.04
4173810-17381086.39087.02
5171635-17163585.30985.92
6175254-17525487.10887.77
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1193212-19321296.03493.011.8196.8293.791.80
2188053-18805393.46994.25
3184639-18463991.77292.54
4185415-18541592.15892.93
5184026-18402691.46892.22
6187482-18748293.18693.99
240min1198732-19873298.77795.231.9499.7396.161.93
2191718-19171895.29196.23
3189113-18911393.99694.92
4189411-18941194.14495.07
5189050-18905093.96594.87
6191509-19150995.18796.14
极限1200447-20044799.63095.542.31100.7596.632.31
2192692-19269295.77596.87
3189795-18979594.33595.41
4190996-19099694.93296.01
5187425-18742593.15794.22
6191988-19198895.42596.54
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