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%
116.643908083907953906773904603906723906820.04
216.483940443936403938420.08
单位质量响应值RSD%判断
23478.4923898.181.26数据可信
影响因素30天-包装高温-供试品溶液-20250302921批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18833-88332.2372.156.532.242.156.54
28477-84772.1472.15
38231-82312.0852.08
47581-75811.9201.92
58528-85282.1602.16
69211-92112.3332.33
10min116990-169904.3044.697.084.314.697.09
218279-182794.6304.63
318441-184414.6714.67
417352-173524.3954.40
519380-193804.9094.91
620536-205365.2025.21
15min125673-256736.5036.965.796.516.975.82
227317-273176.9206.93
327772-277727.0357.05
425625-256256.4916.50
529070-290707.3647.38
629284-292847.4187.43
20min133531-335318.4949.105.478.529.125.45
235937-359379.1039.13
336802-368029.3229.35
433577-335778.5058.53
537694-376949.5489.57
637957-379579.6159.64
30min147229-4722911.96412.624.7212.0012.664.73
250630-5063012.82512.86
349733-4973312.59812.64
446825-4682511.86111.90
552131-5213113.20513.25
652255-5225513.23713.28
45min164785-6478516.41117.8512.1016.4717.9112.06
267869-6786917.19217.25
368340-6834017.31117.37
463882-6388216.18216.24
587086-8708622.06022.12
670857-7085717.94918.01
60min178898-7889819.98621.225.5420.0721.315.55
290076-9007622.81722.91
383648-8364821.18921.28
477976-7797619.75219.83
585748-8574821.72121.82
686326-8632621.86721.96
90min1100268-10026825.39926.483.7825.5226.603.78
2104727-10472726.52826.65
3107340-10734027.19027.31
499136-9913625.11225.23
5107185-10718527.15127.29
6108496-10849627.48327.61
120min1116696-11669629.56030.523.2529.7230.693.26
2121341-12134130.73730.91
3122006-12200630.90531.07
4114910-11491029.10829.26
5122774-12277431.10031.28
6125257-12525731.72931.90
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1136145-13614534.48735.332.8434.6935.552.86
2139871-13987135.43135.65
3141749-14174935.90636.13
4133367-13336733.78333.99
5141944-14194435.95636.19
6143789-14378936.42336.65
240min1148034-14803437.49838.372.5637.7638.642.57
2151796-15179638.45138.73
3154527-15452739.14339.42
4145799-14579936.93237.19
5152704-15270438.68138.97
6155928-15592839.49839.79
极限1151264-15126438.31739.272.7238.6439.612.73
2154218-15421839.06539.41
3158755-15875540.21440.56
4149097-14909737.76838.09
5157250-15725039.83340.19
6159480-15948040.39840.75
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%
116.643926953927373920213927413927983925980.09
216.483952373955043953700.05
单位质量响应值RSD%判断
23593.6323990.901.19数据可信
影响因素30天-裸放高温-供试品溶液-20250302921批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115904-159044.0113.963.294.013.963.26
215073-150733.8013.80
315748-157483.9723.97
416540-165404.1714.17
515571-155713.9273.93
615289-152893.8563.86
10min133339-333398.4088.462.088.418.462.10
232424-324248.1778.18
333594-335948.4728.48
434142-341428.6118.62
533331-333318.4068.41
634392-343928.6748.68
15min150931-5093112.84512.581.2912.8712.601.29
249779-4977912.55412.57
349913-4991312.58812.61
449637-4963712.51812.54
548962-4896212.34812.37
650047-5004712.62212.64
20min166580-6658016.79216.411.6316.8316.451.63
265001-6500116.39316.43
365188-6518816.44016.48
464239-6423916.20116.24
563643-6364316.05116.09
665804-6580416.59616.64
30min193112-9311223.48323.282.7223.5523.342.72
290661-9066122.86522.93
391019-9101922.95523.02
490399-9039922.79922.87
597023-9702324.46924.54
691550-9155023.08923.16
45min1126715-12671531.95831.071.5432.0731.181.54
2123204-12320431.07231.18
3122999-12299931.02031.13
4121995-12199530.76730.87
5121210-12121030.56930.68
6123131-12313131.05431.16
60min1153733-15373338.77238.242.7938.9338.402.77
2150267-15026737.89738.06
3150279-15027937.90038.06
4159136-15913640.13440.29
5147645-14764537.23637.40
6148708-14870837.50437.66
90min1190490-19049048.04247.261.2848.2747.481.28
2189352-18935247.75547.98
3188555-18855547.55447.78
4186080-18608046.92947.15
5184985-18498546.65346.87
6184899-18489946.63246.85
120min1217224-21722454.78454.330.9455.0954.630.94
2217516-21751654.85855.16
3216272-21627254.54454.85
4215537-21553754.35954.66
5212874-21287453.68753.99
6213094-21309453.74254.04
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1254031-25403164.06763.570.8064.4763.960.80
2253245-25324563.86864.26
3253449-25344963.92064.31
4252135-25213563.58963.98
5248620-24862062.70263.09
6250968-25096863.29463.68
240min1277730-27773070.04469.151.5270.5569.651.52
2275977-27597769.60270.10
3277389-27738969.95870.46
4275520-27552069.48669.99
5271554-27155468.48668.98
6266974-26697467.33167.83
极限1285025-28502571.88371.390.6172.5172.010.61
2284689-28468971.79972.41
3283418-28341871.47872.09
4282768-28276871.31471.93
5282222-28222271.17671.78
6280394-28039470.71571.32
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