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%
116.599890798989987539873498835988440.11
216.689923499357992960.09
单位质量响应值RSD%判断
5958.055953.000.06数据可信
供试品溶液-2批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181182-8118281.62583.452.2981.6283.452.29
284763-8476385.22585.23
380486-8048680.92580.92
482885-8288583.33783.34
585233-8523385.69885.70
683433-8343383.88883.89
10min188340-8834088.82291.132.5189.2891.592.50
290125-9012590.61791.09
393960-9396094.47294.92
489798-8979890.28890.75
592844-9284493.35093.83
688722-8872289.20689.67
15min192061-9206192.56392.271.7693.5193.241.74
289416-8941689.90490.88
393193-9319393.70194.68
492022-9202292.52493.49
593566-9356694.07695.07
690362-9036290.85591.82
20min192267-9226792.77092.911.7794.2394.391.76
291598-9159892.09893.57
393035-9303593.54295.04
493610-9361094.12195.60
594237-9423794.75196.27
689672-8967290.16191.63
30min192424-9242492.92892.541.7894.9094.541.76
289894-8989490.38492.37
393382-9338293.89195.91
491357-9135791.85593.86
594270-9427094.78496.83
690903-9090391.39993.37
45min187485-8748587.96290.782.1090.4593.302.08
289126-8912689.61292.10
392168-9216892.67195.21
490156-9015690.64893.16
592550-9255093.05595.63
690269-9026990.76193.24
60min191192-9119291.68991.882.5594.6794.892.51
289648-8964890.13793.12
395296-9529695.81698.87
490957-9095791.45394.47
592504-9250493.00896.10
688672-8867289.15692.13
90min190996-9099691.49291.551.9194.9895.071.89
289711-8971190.20093.69
393996-9399694.50998.09
490092-9009290.58394.11
592070-9207092.57296.18
689428-8942889.91693.39
120min1-0.0000.00-4.004.041.58
2-0.0003.99
3-0.0004.11
4-0.0004.03
5-0.0004.12
6-0.0003.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1-0.0000.00-4.004.041.58
2-0.0003.99
3-0.0004.11
4-0.0004.03
5-0.0004.12
6-0.0003.97
240min1-0.0000.00-4.004.041.58
2-0.0003.99
3-0.0004.11
4-0.0004.03
5-0.0004.12
6-0.0003.97
极限1-0.0000.00-4.004.041.58
2-0.0003.99
3-0.0004.11
4-0.0004.03
5-0.0004.12
6-0.0003.97
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%
116.599889798979989209888598835989030.06
216.689945199401994260.04
单位质量响应值RSD%判断
5961.605960.790.01数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114062-1406214.12514.984.6514.1314.984.63
215184-1518415.25215.25
314811-1481114.87814.88
414155-1415514.21914.22
515540-1554015.61015.61
615699-1569915.77015.77
10min129284-2928429.41629.901.5229.4929.981.53
229507-2950729.64029.72
329769-2976929.90329.99
429444-2944429.57629.66
530454-3045430.59130.68
630136-3013630.27130.36
15min138372-3837238.54538.751.7738.7939.001.77
238530-3853038.70338.95
339073-3907339.24939.50
437346-3734637.51437.76
539188-3918839.36439.62
638948-3894839.12339.38
20min145772-4577245.97845.371.9146.4345.831.90
245549-4554945.75446.22
345470-4547045.67446.14
443441-4344143.63644.09
545481-4548145.68546.16
645261-4526145.46545.94
30min152299-5229952.53452.371.0653.2553.091.07
252223-5222352.45853.18
352448-5244852.68453.40
451136-5113651.36652.06
552738-5273852.97553.70
651984-5198452.21852.94
45min159981-5998160.25160.561.5661.2561.561.56
260765-6076561.03862.05
361042-6104261.31662.33
458526-5852658.78959.77
560884-6088461.15862.18
660507-6050760.77961.79
60min165481-6548165.77565.601.1367.1166.941.12
264509-6450964.79966.15
365600-6560065.89567.25
464443-6444364.73366.04
566391-6639166.69068.05
665417-6541765.71167.06
90min172251-7225172.57672.092.0474.2873.802.01
271285-7128571.60673.31
371151-7115171.47173.19
469463-6946369.77571.44
572931-7293173.25974.99
673534-7353473.86575.58
120min173648-7364873.97974.402.0876.0976.512.05
273200-7320073.52975.64
374277-7427774.61176.73
472603-7260372.92974.98
576989-7698977.33579.48
673696-7369674.02776.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min178246-7824678.59878.921.4581.1281.441.45
277980-7798078.33180.85
379507-7950779.86482.40
476729-7672977.07479.53
579216-7921679.57282.14
679718-7971880.07682.62
240min182669-8266983.04183.542.0686.0086.502.03
281584-8158481.95184.90
384656-8465685.03788.01
481094-8109481.45984.35
585440-8544085.82488.84
683567-8356783.94386.93
极限182505-8250582.87684.231.9686.2987.651.94
283639-8363984.01587.42
385063-8506385.44588.89
481366-8136681.73285.07
585188-8518885.57189.06
685328-8532885.71289.16
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%
116.599915399429993919905099001992050.20
216.681009581011471010520.14
单位质量响应值RSD%判断
5979.816058.270.93数据可信
供试品溶液-2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%
5min116052-1605215.97015.811.1315.9715.811.14
215881-1588115.80015.80
315621-1562115.54115.54
415743-1574315.66215.66
516050-1605015.96815.97
616013-1601315.93115.93
10min129965-2996529.81229.810.7529.9029.900.75
229590-2959029.43929.53
329905-2990529.75229.84
429948-2994829.79529.88
530121-3012129.96730.06
630251-3025130.09630.18
15min137099-3709936.90937.551.6937.1637.801.68
237287-3728737.09637.35
337819-3781937.62637.88
437596-3759637.40437.66
537749-3774937.55637.81
638910-3891038.71138.97
20min142013-4201341.79842.491.0842.2642.951.07
242533-4253342.31542.77
342890-4289042.67143.13
442446-4244642.22942.69
543208-4320842.98743.45
643134-4313442.91343.38
30min150865-5086550.60550.280.8851.3050.980.87
250562-5056250.30351.00
350378-5037850.12050.82
449825-4982549.57050.27
550461-5046150.20350.91
651112-5111250.85151.56
45min158179-5817957.88157.650.6058.8558.630.59
257410-5741057.11658.09
358203-5820357.90558.88
458216-5821657.91858.89
557636-5763657.34158.32
658061-5806157.76458.76
60min161520-6152061.20561.502.3362.5062.792.30
261005-6100560.69361.98
361157-6115760.84462.14
462110-6211061.79263.08
560536-6053660.22661.53
664545-6454564.21565.53
90min167968-6796867.62068.351.3669.2569.981.34
269559-6955969.20370.83
367345-6734567.00168.64
468682-6868268.33169.97
568822-6882268.47070.10
669811-6981169.45471.12
120min173004-7300472.63173.040.8774.6475.060.85
272585-7258572.21474.22
373405-7340573.03075.04
473847-7384773.46975.48
574391-7439174.01176.03
673259-7325972.88474.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min178632-7863278.23078.170.6080.6480.590.60
277991-7799177.59280.00
378601-7860178.19980.61
478104-7810477.70580.13
578850-7885078.44780.87
679242-7924278.83781.30
240min183062-8306282.63780.951.2085.4983.811.17
281365-8136580.94983.79
380362-8036279.95182.80
480713-8071380.30083.16
580887-8088780.47383.34
681817-8181781.39984.30
极限180691-8069180.27880.300.7983.5983.610.77
281342-8134280.92684.22
379561-7956179.15482.45
480602-8060280.19083.49
580894-8089480.48083.79
681194-8119480.77984.13
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