多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.313324933152330373294733261331290.42
210.253294532741328430.44
单位质量响应值RSD%判断
3213.293204.200.21数据可信
加速6月-供试品溶液-2025072421批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14544-454412.70610.8214.3312.7110.8214.35
23494-34949.7709.77
33545-35459.9129.91
43542-35429.9049.90
54621-462112.92112.92
63466-34669.6919.69
10min19123-912325.50922.617.5925.5322.627.59
27458-745820.85420.87
38232-823223.01823.03
47701-770121.53321.55
58332-833223.29823.32
67662-766221.42421.44
15min111848-1184833.12931.076.5633.1931.126.56
210390-1039029.05229.10
312176-1217634.04634.10
410643-1064329.75929.81
510966-1096630.66330.72
610647-1064729.77129.82
20min113490-1349037.72036.133.2337.8436.243.24
212722-1272235.57335.67
313223-1322336.97337.09
412338-1233834.49934.60
513062-1306236.52336.63
612690-1269035.48335.58
30min115910-1591044.48744.021.6844.6744.191.68
215548-1554843.47543.63
316090-1609044.99045.16
415450-1545043.20043.36
515539-1553943.44943.62
615922-1592244.52044.68
45min118948-1894852.98152.191.2453.2452.441.25
218497-1849751.72051.95
318770-1877052.48452.73
418849-1884952.70552.94
518334-1833451.26551.51
618599-1859952.00652.24
60min120722-2072257.94257.260.8158.2957.580.82
220550-2055057.46157.78
320499-2049957.31857.65
420380-2038056.98657.30
520230-2023056.56656.90
620477-2047757.25757.58
90min121959-2195961.40163.121.8261.8463.551.80
222950-2295064.17264.58
322935-2293564.13064.56
422863-2286363.92864.34
522257-2225762.23462.66
622489-2248962.88363.30
120min124115-2411567.42967.921.3667.9768.441.35
224591-2459168.76069.28
324629-2462968.86669.40
424092-2409267.36567.89
523813-2381366.58567.11
624496-2449668.49469.02
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124849-2484969.48170.011.5470.1470.651.53
224966-2496669.80970.44
325470-2547071.21871.87
425212-2521270.49671.13
524406-2440668.24368.88
625325-2532570.81271.45
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.313264532465325683222932384324580.50
210.253293832652327950.62
单位质量响应值RSD%判断
3148.213199.511.15数据可信
加速6月-供试品溶液-2025072521批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14763-476313.46511.0922.1913.4711.0922.21
23870-387010.94110.94
34447-444712.57212.57
42667-26677.5407.54
53110-31108.7928.79
64675-467513.21713.22
10min18321-832123.52421.9412.5923.5521.9612.60
27580-758021.42921.45
38579-857924.25324.27
46318-631817.86117.87
56981-698119.73619.75
68793-879324.85824.88
15min111666-1166632.98030.558.7233.0430.618.73
210579-1057929.90729.96
311806-1180633.37633.44
49468-946826.76726.81
510024-1002428.33828.39
611298-1129831.94032.00
20min113418-1341837.93336.006.3638.0536.116.38
212814-1281436.22636.33
313453-1345338.03238.15
411586-1158632.75432.84
511891-1189133.61733.71
613244-1324437.44237.56
30min116252-1625245.94544.674.4146.1344.844.43
215954-1595445.10345.27
316553-1655346.79646.98
414737-1473741.66241.80
515177-1517742.90643.06
616131-1613145.60345.78
45min119010-1901053.74252.942.7054.0053.182.72
218796-1879653.13753.38
319186-1918654.24054.50
418754-1875453.01953.23
517746-1774650.16950.39
618856-1885653.30753.56
60min120922-2092259.14857.693.6459.4958.023.65
221160-2116059.82160.15
320785-2078558.76059.11
419600-1960055.41055.71
519367-1936754.75255.06
620604-2060458.24958.59
90min122467-2246763.51663.863.7563.9664.283.75
223661-2366166.89167.32
323411-2341166.18466.63
421672-2167261.26861.66
521648-2164861.20061.60
622671-2267164.09264.53
120min124697-2469769.82068.793.5170.3769.323.52
224952-2495270.54171.08
325095-2509570.94571.50
423021-2302165.08265.58
523513-2351366.47366.97
624714-2471469.86870.42
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125503-2550372.09870.882.1472.7771.532.16
225105-2510570.97371.63
325549-2554972.22972.90
424266-2426668.60169.20
524588-2458869.51270.12
625430-2543071.89272.56
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