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TAAF230001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(%)99.8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%
115.869493494992949739514595363950810.19
215.819593595913959240.02
单位质量响应值RSD%判断
5995.026067.300.85数据可信
供试品溶液-24043001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%
5min110370-1037010.29610.484.0310.3010.484.04
210549-1054910.47410.47
310284-1028410.21110.21
410675-1067510.59910.60
511336-1133611.25511.26
610141-1014110.06910.07
10min121114-2111420.96420.850.3421.0220.910.33
220918-2091820.76920.83
321013-2101320.86320.92
420934-2093420.78520.84
520996-2099620.84720.91
621010-2101020.86020.92
15min128295-2829528.09429.012.2328.2729.192.22
229147-2914728.93929.11
329403-2940329.19429.37
428784-2878428.57928.75
530194-3019429.97930.16
629512-2951229.30229.47
20min134317-3431734.07334.931.3534.4035.261.35
235087-3508734.83735.17
335115-3511534.86535.20
435613-3561335.35935.69
535527-3552735.27435.62
635422-3542235.17035.50
30min141961-4196141.66242.001.2142.1842.531.21
242671-4267142.36742.90
341716-4171641.41941.95
442374-4237442.07242.60
543076-4307642.76943.31
641994-4199441.69542.22
45min148179-4817947.83648.311.9848.5949.081.95
250190-5019049.83350.60
348854-4885448.50649.26
447674-4767447.33548.10
549230-4923048.87949.66
647828-4782847.48748.25
60min152699-5269952.32453.461.6053.3454.491.59
253722-5372253.33954.38
353598-5359853.21654.24
454458-5445854.07055.10
555171-5517154.77855.83
653411-5341153.03154.06
90min159824-5982459.39859.221.4760.7060.541.45
260547-6054760.11661.45
358860-5886058.44159.76
459155-5915558.73460.06
560760-6076060.32761.68
658719-5871958.30159.62
120min162543-6254362.09862.590.4663.7364.240.48
263317-6331762.86664.54
363102-6310262.65364.30
462853-6285362.40564.06
563248-6324862.79864.49
663144-6314462.69464.34
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166486-6648666.01365.611.1167.9967.621.09
266288-6628865.81667.84
366294-6629465.82267.82
465642-6564265.17567.17
566940-6694066.46368.50
664855-6485564.39366.39
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TAAF230001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(%)99.8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%
115.869551195976958249584095608957520.20
215.819747097370974200.08
单位质量响应值RSD%判断
6037.336161.921.45数据可信
供试品溶液-24043002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%
5min111149-1114910.94611.733.8510.9511.723.83
212104-1210411.88411.88
312069-1206911.84911.85
412509-1250912.28112.28
512084-1208411.86411.86
611742-1174211.52811.53
10min121664-2166421.27021.491.2921.3321.561.29
221778-2177821.38221.45
321929-2192921.53021.60
422428-2242822.02022.09
521846-2184621.44821.51
621697-2169721.30221.37
15min130276-3027629.72529.151.3229.9029.341.30
229829-2982929.28629.47
329366-2936628.83229.02
429868-2986829.32429.52
529618-2961829.07929.26
629184-2918428.65328.84
20min135017-3501734.38028.5549.0334.7228.9048.44
235335-3533534.69235.04
334253-3425333.63033.98
435650-3565035.00135.35
5-0.0000.35
634221-3422133.59833.94
30min141717-4171740.95840.003.5841.4940.513.56
241594-4159440.83741.38
337937-3793737.24737.78
440953-4095340.20840.76
540538-4053839.80040.15
641738-4173840.97841.51
45min148429-4842947.54847.882.2948.3148.602.16
250002-5000249.09249.86
348439-4843947.55848.30
448039-4803947.16547.94
550233-5023349.31949.89
647435-4743546.57247.33
60min149977-4997749.06851.252.2550.0952.252.22
252699-5269951.74052.78
353225-5322552.25653.26
452617-5261751.65952.69
551912-5191250.96751.81
652794-5279451.83352.85
90min158971-5897157.89857.191.2159.2058.471.29
258689-5868957.62158.95
358603-5860357.53758.83
458322-5832257.26158.58
557041-5704156.00357.13
657868-5786856.81558.12
120min163032-6303261.88561.280.8863.5162.870.82
262442-6244261.30662.95
361518-6151860.39962.01
462388-6238861.25362.89
562908-6290861.76363.20
662176-6217661.04562.66
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166471-6647165.26164.071.1767.2366.001.22
264915-6491563.73465.72
365330-6533064.14166.09
465259-6525964.07166.05
564140-6414062.97364.75
665415-6541564.22566.18
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TAAF230001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(%)99.8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%
115.869580395602960219569195260956750.30
215.819675496370965620.29
单位质量响应值RSD%判断
6032.476107.650.88数据可信
供试品溶液-24043003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%
5min136044-3604435.55836.012.0835.5636.012.08
237893-3789337.38237.38
336818-3681836.32236.32
436238-3623835.74935.75
536194-3619435.70635.71
635824-3582435.34135.34
10min148528-4852847.87448.622.5048.0748.822.49
250996-5099650.30950.52
347526-4752646.88547.09
450165-5016549.48949.69
549525-4952548.85749.06
648950-4895048.29048.49
15min155910-5591055.15655.721.5555.6256.191.54
257288-5728856.51657.00
357038-5703856.26956.73
455066-5506654.32454.80
557198-5719856.42756.90
656361-5636155.60156.07
20min157703-5770356.92559.603.2157.7060.383.17
261592-6159260.76261.56
358276-5827657.49058.27
462353-6235361.51262.29
561585-6158560.75561.54
660949-6094960.12760.90
30min165603-6560364.71965.981.8965.8067.091.88
267197-6719766.29167.43
365171-6517164.29265.39
467917-6791767.00168.12
568365-6836567.44368.56
667030-6703066.12667.23
45min171315-7131570.35470.310.8571.8071.790.83
270932-7093269.97671.48
371216-7121670.25671.71
472266-7226671.29272.78
571442-7144270.47971.97
670456-7045669.50670.98
60min175652-7565274.63274.621.8676.4776.491.84
276407-7640775.37777.27
373143-7314372.15774.00
477072-7707276.03377.92
576483-7648375.45277.34
675091-7509174.07975.94
90min178404-7840477.34778.142.4079.6080.422.34
280575-8057579.48981.80
380458-8045879.37381.62
479983-7998378.90581.21
580131-8013179.05181.36
675686-7568674.66676.94
120min180252-8025279.17079.971.3281.8582.681.31
282781-8278181.66584.42
380855-8085579.76582.45
480917-8091779.82682.57
581735-8173580.63383.38
679822-7982278.74681.43
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184375-8437583.23881.371.3986.3684.531.33
282961-8296181.84385.05
382897-8289781.77984.91
481492-8149280.39383.58
581691-8169180.59083.78
681496-8149680.39783.52
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