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%
116.129671596891968369690596910968510.09
216.179752897581975540.04
单位质量响应值RSD%判断
6008.136033.020.30数据可信
供试品溶液-2K72SDB2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%
5min15165-51655.1475.426.545.155.426.50
25910-59105.8905.89
35339-53395.3215.32
45367-53675.3495.35
55834-58345.8145.81
65033-50335.0165.02
10min114633-1463314.58314.663.4914.6114.693.50
215492-1549215.43915.47
315009-1500914.95814.99
414531-1453114.48114.51
514664-1466414.61414.65
613953-1395313.90513.93
15min122880-2288022.80223.122.5522.9123.232.55
224259-2425924.17624.29
323377-2337723.29723.41
423067-2306722.98823.10
523098-2309823.01923.13
622522-2252222.44522.55
20min130976-3097630.87030.292.2031.1130.532.19
231104-3110430.99831.25
330796-3079630.69130.93
430185-3018530.08230.32
529435-2943529.33529.58
629886-2988629.78430.01
30min140863-4086340.72440.892.0441.1341.302.04
242215-4221542.07142.50
341839-4183941.69642.11
440481-4048140.34340.75
540793-4079340.65441.06
640014-4001439.87740.27
45min152902-5290252.72151.992.0853.3652.632.07
253933-5393353.74954.41
352141-5214151.96352.61
451142-5114250.96751.60
551234-5123451.05951.69
651664-5166451.48852.10
60min160006-6000659.80159.901.6160.7360.821.61
261678-6167861.46762.42
360649-6064960.44261.37
459043-5904358.84159.75
559971-5997159.76660.68
659263-5926359.06159.96
90min169808-6980869.57070.251.0370.8371.511.04
271535-7153571.29172.59
370754-7075470.51271.78
470011-7001169.77271.01
571049-7104970.80672.05
669808-6980869.57070.80
120min176495-7649576.23476.621.3877.8878.271.38
278868-7886878.59980.29
377245-7724576.98178.64
476024-7602475.76577.39
576286-7628676.02677.66
676384-7638476.12377.74
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182490-8249082.20879.482.4684.2881.552.42
281183-8118380.90683.04
380160-8016079.88681.97
476946-7694676.68378.73
578866-7886678.59780.66
678869-7886978.60080.64
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%
116.129786697996980109793098009979620.07
216.179803798184981100.11
单位质量响应值RSD%判断
6077.056067.410.12数据可信
供试品溶液-3A75SDB1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%
5min15989-59895.9185.317.995.925.318.00
25626-56265.5595.56
35257-52575.1945.19
45344-53445.2805.28
55323-53235.2605.26
64695-46954.6394.64
10min115744-1574415.55714.624.2615.5914.644.26
215311-1531115.12915.16
314383-1438314.21214.24
414430-1443014.25814.29
514078-1407813.91113.94
614805-1480514.62914.65
15min123910-2391023.62623.703.3323.7423.813.33
225174-2517424.87524.99
323753-2375323.47023.58
424629-2462924.33624.44
522960-2296022.68722.79
623493-2349323.21423.32
20min132925-3292532.53331.252.9932.7831.492.98
231701-3170131.32431.58
330944-3094430.57630.81
431672-3167231.29531.54
530249-3024929.88930.12
632256-3225631.87232.11
30min142311-4231141.80841.542.1142.2441.962.09
241990-4199041.49141.92
343490-4349042.97343.38
442202-4220241.70042.12
541203-4120340.71341.11
641041-4104140.55340.97
45min152459-5245951.83552.814.1552.5053.464.11
253600-5360052.96253.62
357476-5747656.79257.44
454004-5400453.36254.01
551576-5157650.96351.59
651573-5157350.96051.60
60min166388-6638865.59861.513.3766.5562.453.34
261461-6146160.73061.68
361434-6143460.70361.67
462368-6236861.62662.57
560879-6087960.15561.06
660957-6095760.23261.15
90min175796-7579674.89470.513.4276.2171.793.39
271143-7114370.29771.59
371785-7178570.93172.23
470916-7091670.07371.36
568698-6869867.88169.12
669790-6979068.96070.22
120min176451-7645175.54276.972.3777.2778.642.33
278826-7882677.88879.57
380302-8030279.34781.04
477376-7737676.45678.13
575336-7533674.44076.06
679082-7908278.14179.78
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184430-8443083.42680.872.6285.5882.972.58
280106-8010679.15381.27
380492-8049279.53581.67
484547-8454783.54185.64
579849-7984978.89980.93
681619-8161980.64882.72
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