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%
116.453997813988963955193993163984443983910.43
216.524016973967633992300.88
单位质量响应值RSD%判断
24218.3024166.460.16数据可信
供试品溶液-3F70SDB1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%
5min137063-370639.19210.136.039.1910.136.05
243930-4393010.89510.90
339718-397189.8519.85
439922-399229.9019.90
541631-4163110.32510.32
642786-4278610.61110.61
10min170394-7039417.45918.583.2317.4718.603.24
276286-7628618.92018.94
374884-7488418.57218.59
477066-7706619.11319.13
576357-7635718.93718.95
674533-7453318.48518.50
15min1104441-10444125.90326.631.8725.9526.681.87
2108406-10840626.88626.94
3107271-10727126.60526.65
4109380-10938027.12827.18
5109204-10920427.08427.13
6105642-10564226.20126.25
20min1135731-13573133.66333.441.0833.7533.531.07
2134345-13434533.31933.41
3135057-13505733.49633.59
4136520-13652033.85933.95
5135020-13502033.48733.58
6132294-13229432.81132.90
30min1171220-17122042.46543.010.8042.6143.160.80
2174694-17469443.32643.48
3173884-17388443.12543.27
4174715-17471543.33143.48
5173591-17359143.05343.20
6172406-17240642.75942.91
45min1214328-21432853.15653.561.0053.3753.781.01
2216496-21649653.69453.92
3216663-21666353.73553.95
4217184-21718453.86454.09
5218480-21848054.18654.41
6212506-21250652.70452.92
60min1244342-24434260.60061.531.2760.9061.841.27
2249954-24995461.99262.30
3247421-24742161.36361.67
4248924-24892461.73662.05
5252757-25275762.68763.00
6245083-24508360.78461.09
90min1285200-28520070.73371.030.7071.1471.440.70
2288815-28881571.63072.04
3285009-28500970.68671.10
4289037-28903771.68572.10
5285525-28552570.81471.23
6284728-28472870.61671.02
120min1315580-31558078.26877.911.0578.7978.441.05
2314395-31439577.97478.51
3310439-31043976.99377.52
4318558-31855879.00679.54
5315708-31570878.29978.83
6310104-31010476.91077.43
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1325315-32531580.68280.741.3381.3381.401.32
2327889-32788981.32081.98
3321894-32189479.83480.49
4333066-33306682.60483.27
5323067-32306780.12580.79
6322169-32216979.90280.55
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%
116.453987793953493985923992833967203977450.42
216.523950883992713971800.75
单位质量响应值RSD%判断
24179.0324042.370.41数据可信
供试品溶液-3F70SDB1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%
5min144756-4475611.13810.287.0911.1410.287.09
241944-4194410.43810.44
340134-401349.9889.99
444076-4407610.96810.97
539959-399599.9449.94
636876-368769.1779.18
10min176624-7662419.06818.652.5719.0918.672.58
276646-7664619.07419.09
374023-7402318.42118.44
476630-7663019.07019.09
572386-7238618.01418.03
673367-7336718.25818.27
15min1108443-10844326.98626.641.3727.0426.691.38
2108181-10818126.92126.97
3106378-10637826.47326.52
4108285-10828526.94727.00
5104888-10488826.10226.15
6106153-10615326.41726.46
20min1136072-13607233.86232.932.4733.9633.022.47
2134321-13432133.42633.52
3128274-12827431.92232.01
4134237-13423733.40533.50
5128449-12844931.96532.06
6132586-13258632.99533.08
30min1174005-17400543.30242.612.3643.4542.762.35
2174295-17429543.37443.52
3164040-16404040.82240.97
4173991-17399143.29843.45
5169122-16912242.08742.23
6171845-17184542.76442.91
45min1218735-21873554.43353.462.4654.6653.682.46
2218645-21864554.41154.63
3205240-20524051.07551.29
4218371-21837154.34354.57
5212710-21271052.93453.15
6215244-21524453.56453.78
60min1248778-24877861.90961.341.8262.2261.651.82
2249435-24943562.07362.39
3239000-23900059.47659.77
4249636-24963662.12362.44
5242930-24293060.45460.76
6249254-24925462.02862.33
90min1293980-29398073.15871.732.2773.5872.142.27
2289911-28991172.14672.56
3276572-27657268.82669.22
4292657-29265772.82973.25
5284824-28482470.88071.28
6291423-29142372.52272.93
120min1318325-31832579.21778.431.7479.7678.961.74
2318486-31848679.25779.79
3304404-30440475.75276.26
4315924-31592478.61979.16
5315322-31532278.46978.99
6318600-31860079.28579.81
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1330710-33071082.29981.062.7982.9781.722.78
2330156-33015682.16182.83
3308365-30836576.73877.38
4327770-32777081.56782.24
5324006-32400680.63081.28
6333343-33334382.95483.62
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%
116.451964531985891968751986761992291979640.62
216.521996212004992000600.32
单位质量响应值RSD%判断
12034.2912110.170.45数据可信
供试品溶液-3E99SDC1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%
5min114010-140106.9637.143.316.967.143.29
214703-147037.3087.31
314421-144217.1677.17
414034-140346.9756.98
515097-150977.5037.50
613875-138756.8966.90
10min125618-2561812.73215.4811.9812.7415.4911.98
233239-3323916.52016.53
336791-3679118.28618.30
430072-3007214.94614.96
531250-3125015.53215.54
629900-2990014.86114.87
15min141892-4189220.82124.208.5420.8524.238.55
253976-5397626.82726.87
351507-5150725.60025.64
448432-4843224.07124.11
549475-4947524.59024.63
646816-4681623.26823.30
20min156594-5659428.12832.147.5428.2032.227.54
270759-7075935.16835.25
368132-6813233.86333.95
463823-6382331.72131.80
565699-6569932.65332.73
663026-6302631.32531.40
30min179341-7934139.43444.398.3739.5544.528.37
2101492-10149250.44350.59
393292-9329246.36746.51
487311-8731143.39543.52
588407-8840743.93944.07
686045-8604542.76642.89
45min1102589-10258950.98856.055.5351.1756.265.54
2119813-11981359.54959.78
3118625-11862558.95859.18
4111800-11180055.56655.77
5113334-11333456.32956.54
6110522-11052254.93155.13
60min1120262-12026259.77265.005.1760.0465.305.18
2139186-13918669.17769.50
3136155-13615567.67167.99
4128400-12840063.81764.11
5132787-13278765.99766.30
6127848-12784863.54263.83
90min1142438-14243870.79476.274.6371.1676.684.64
2162509-16250980.76981.21
3159218-15921879.13379.56
4151058-15105875.07875.48
5154800-15480076.93877.35
6150741-15074174.92075.32
120min1155447-15544777.25983.084.4677.7483.614.47
2175671-17567187.31187.89
3173863-17386386.41286.97
4163597-16359781.31081.84
5169398-16939884.19384.73
6164937-16493781.97682.50
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1164599-16459981.80886.363.4482.4287.033.46
2181782-18178290.34891.07
3177775-17777588.35789.06
4170943-17094384.96185.62
5175406-17540687.17987.86
6172032-17203285.50286.16
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%
116.451985852004811992062003912012321999790.54
216.521992271968721980500.85
单位质量响应值RSD%判断
12156.7811988.500.99数据可信
供试品溶液-3E99SDC1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%
5min116901-169018.4008.123.098.408.123.07
216950-169508.4248.42
315628-156287.7677.77
416104-161048.0048.00
516248-162488.0768.08
616223-162238.0638.06
10min134643-3464317.21816.922.8617.2316.932.85
232625-3262516.21516.23
333507-3350716.65416.67
434275-3427517.03517.05
533723-3372316.76116.77
635430-3543017.60917.62
15min153755-5375526.71725.283.2226.7625.323.22
248858-4885824.28324.32
350250-5025024.97525.02
451241-5124125.46825.51
550202-5020224.95124.99
650896-5089625.29625.34
20min166011-6601132.80932.212.0632.9032.302.06
262745-6274531.18531.27
365282-6528232.44632.53
466167-6616732.88632.97
564917-6491732.26532.35
663772-6377231.69631.78
30min188670-8867044.07043.192.2344.2143.332.23
284117-8411741.80741.94
387472-8747243.47543.61
489259-8925944.36344.50
586285-8628542.88543.02
685636-8563642.56242.70
45min1113213-11321356.26955.712.1956.4855.922.19
2107548-10754853.45353.66
3112996-11299656.16156.37
4113709-11370956.51556.73
5111111-11111155.22455.43
6114015-11401556.66756.88
60min1131372-13137265.29464.282.0665.6064.592.06
2125410-12541062.33162.62
3130540-13054064.88065.18
4132635-13263565.92266.23
5127680-12768063.45963.76
6128412-12841263.82364.13
90min1154310-15431076.69575.401.8277.1175.811.82
2147728-14772873.42373.82
3152684-15268475.88676.30
4153941-15394176.51176.93
5152712-15271275.90076.31
6148834-14883473.97374.38
120min1167256-16725683.12982.451.3883.6782.991.38
2161379-16137980.20880.73
3165918-16591882.46483.00
4167517-16751783.25983.80
5166775-16677582.89083.42
6166529-16652982.76883.30
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1172569-17256985.77085.241.8786.4585.921.87
2165689-16568982.35083.00
3172930-17293085.94986.62
4175226-17522687.09087.77
5170930-17093084.95585.63
6171727-17172785.35186.02
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