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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.471309471306661308231308471306861307940.09
216.531314851316271315560.08
单位质量响应值RSD%判断
7941.357958.620.16数据可信
加速3月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121113192913211713202399.5498.820.6598.15%~99.49%
213115813125813120898.93
313161213180713171099.30
413075213072013073698.57
513109313120113114798.88
612948712973512961197.72
2024030221113058913048013053498.4299.750.8098.91%~100.58%
2133090132999133044100.31
313173613203613188699.44
413194713214013204499.56
5132990132503132746100.09
6133504133547133526100.67
2024030321113245013231013238099.81100.951.3999.48%~102.41%
2134396134515134456101.38
3135722135486135604102.24
4133383133274133328100.52
513126513155013140899.08
6136239136085136162102.66
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.471313491317251319451318101316851317030.17
216.531329821329031329420.05
单位质量响应值RSD%判断
7996.548042.470.41数据可信
长期3月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121113222413217313219898.8199.320.4198.90%~99.74%
213283313264613274099.21
313221013253313237298.94
413316913307913312499.50
513338713328113333499.66
613350913355713353399.81
20240302211136766136546136656102.1499.731.2698.41%~101.05%
213249513234513242098.98
313259813243413251699.05
413220513219313219998.81
513297513302513300099.41
613379913375413377699.99
20240303211134969134179134574100.59100.491.5898.83%~102.15%
2137830137969137900103.07
313311113318913315099.52
4133844133874133859100.05
513175913169013172498.45
6135179135727135453101.24
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.471332121332921334121332851335361333470.10
216.531337631338461338040.05
单位质量响应值RSD%判断
8096.368094.620.02数据可信
中间条件3月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121113497913489513493799.9196.532.2294.28%~98.78%
212881912865312873695.32
312898812897912898495.50
412683712714712699294.03
513002112998213000296.26
613242413274413258498.17
2024030221113275313290813283098.3598.691.6397.00%~100.38%
213218713191213205097.77
313424413433313428899.43
413101513080813091296.93
5137102137111137106101.52
613252013253913253098.13
2024030321113262013234513248298.0998.810.9797.81%~99.81%
2135534135438135486100.32
313308013306713307498.53
413233813182013207997.79
513440013452513446299.56
613336613286613311698.56
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