托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.459772697775977649773597419976840.16
216.539756797559975630.01
单位质量响应值RSD%判断
5938.245902.180.44数据可信
供试品溶液-25010201-1-2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%
5min19911-991110.04511.478.9110.0411.478.91
211107-1110711.25711.26
311753-1175311.91211.91
411626-1162611.78311.78
510663-1066310.80710.81
612847-1284713.02013.02
10min123743-2374324.06326.004.6424.1226.064.65
225365-2536525.70725.77
326004-2600426.35526.42
425325-2532525.66725.73
526113-2611326.46526.53
627358-2735827.72727.80
15min133905-3390534.36236.784.5234.5536.994.52
235580-3558036.06036.27
338265-3826538.78138.99
435780-3578036.26336.47
536169-3616936.65736.86
638041-3804138.55438.78
20min139816-3981640.35341.524.5240.7341.934.49
241739-4173942.30242.71
337824-3782438.33438.76
441557-4155742.11742.53
541851-4185142.41542.83
643019-4301943.59944.04
30min146690-4669047.32050.984.1947.9251.634.18
250604-5060451.28751.93
351350-5135052.04352.68
451699-5169952.39653.04
549068-4906849.73050.38
652421-5242153.12853.81
45min153455-5345554.17660.195.4355.0461.115.40
259393-5939360.19461.12
359776-5977660.58261.51
459244-5924460.04360.98
561717-6171762.54963.47
662730-6273063.57664.55
60min164290-6429065.15765.893.7566.3367.153.71
267045-6704567.94969.21
361288-6128862.11563.38
465970-6597066.86068.13
563609-6360964.46765.74
667874-6787468.78970.12
90min176205-7620577.23377.272.8578.7678.902.79
274010-7401075.00876.65
375543-7554376.56278.17
474542-7454275.54777.19
580023-8002381.10282.73
677143-7714378.18379.90
120min177066-7706678.10580.992.8580.0683.052.81
278022-7802279.07481.13
382917-8291784.03586.07
479136-7913680.20382.26
581993-8199383.09985.18
680368-8036881.45283.60
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179016-7901680.08283.152.2082.4885.662.21
280999-8099982.09184.59
383717-8371784.84687.35
481977-8197783.08385.59
582942-8294284.06186.60
683597-8359784.72587.32
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