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%
116.63997201000921001399989299940999570.17
216.669973199800997660.05
单位质量响应值RSD%判断
6010.645988.360.27数据可信
供试品溶液-1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%
5min116277-1627716.24616.354.4616.2516.354.45
215944-1594415.91315.91
316173-1617316.14216.14
417368-1736817.33517.33
517113-1711317.08017.08
615431-1543115.40115.40
10min127868-2786827.81529.544.8627.9029.634.86
229993-2999329.93630.02
327918-2791827.86527.95
431101-3110131.04131.14
531039-3103930.98031.07
629673-2967329.61629.70
15min136355-3635536.28537.583.0736.5337.843.06
239161-3916139.08639.34
336262-3626236.19336.44
438101-3810138.02838.30
538401-3840138.32838.59
637627-3762737.55537.81
20min141558-4155841.47843.102.8941.9243.562.89
243767-4376743.68344.16
341734-4173441.65442.10
444319-4431944.23444.71
544338-4433844.25344.73
643356-4335643.27343.73
30min147809-4780947.71849.712.6048.3950.422.60
250552-5055250.45551.17
348607-4860748.51449.19
450374-5037450.27851.00
550409-5040950.31351.04
651103-5110351.00551.70
45min156720-5672056.61158.222.0757.5559.202.08
258455-5845558.34359.34
357464-5746457.35458.30
458935-5893558.82259.83
560213-6021360.09861.10
658214-5821458.10359.09
60min161455-6145561.33763.842.4762.5965.142.47
264488-6448864.36565.68
362911-6291162.79164.06
465687-6568765.56166.89
563907-6390763.78565.12
665308-6530865.18366.49
90min166094-6609465.96869.402.5967.5671.062.58
270856-7085670.72072.40
369893-6989369.75971.37
471088-7108870.95272.65
569786-6978669.65271.35
669473-6947369.34071.01
120min170130-7013069.99672.422.6271.9674.462.59
272734-7273472.59574.66
371008-7100870.87272.87
473108-7310872.96875.06
572772-7277272.63374.71
675606-7560675.46177.51
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172984-7298472.84474.273.0775.2076.723.00
275946-7594675.80178.27
374507-7450774.36476.76
476315-7631576.16978.66
576187-7618776.04178.53
670560-7056070.42572.90
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%
116.639955199747995999978399695996750.10
216.669952699474995000.04
单位质量响应值RSD%判断
5993.695972.390.26数据可信
供试品溶液-2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%
5min116332-1633216.34616.282.6116.3516.282.60
216175-1617516.18816.19
316908-1690816.92216.92
416507-1650716.52116.52
515701-1570115.71415.71
615963-1596315.97615.98
10min127701-2770127.72428.231.6027.8128.321.59
227637-2763727.66027.75
328715-2871528.73928.83
428430-2843028.45428.55
528232-2823228.25628.34
628548-2854828.57228.66
15min137342-3734237.37336.641.1337.6236.891.12
236722-3672236.75337.00
336102-3610236.13236.39
436444-3644436.47436.72
536465-3646536.49536.74
636589-3658936.61936.87
20min142121-4212142.15642.331.2442.6142.781.22
242379-4237942.41442.86
343254-4325443.29043.74
441692-4169241.72742.18
542223-4222342.25842.71
642111-4211142.14642.60
30min149040-4904049.08150.722.5249.7751.402.48
250055-5005550.09750.78
350966-5096651.00851.70
451556-5155651.59952.28
552568-5256852.61253.29
649878-4987849.92050.60
45min156994-5699457.04158.471.4158.0059.441.39
258269-5826958.31859.28
358761-5876158.81059.79
458166-5816658.21459.19
559136-5913659.18560.16
659195-5919559.24460.21
60min161564-6156461.61562.330.9962.8963.620.98
261977-6197762.02963.31
362162-6216262.21463.52
461976-6197662.02863.32
562777-6277762.82964.13
663240-6324063.29364.58
90min169124-6912469.18269.641.4770.8071.281.44
271044-7104471.10372.73
369653-6965369.71171.36
468289-6828968.34669.98
570457-7045770.51672.17
668931-6893168.98870.63
120min173012-7301273.07374.141.0275.0876.161.01
274070-7407074.13276.16
375317-7531775.38077.42
473786-7378673.84775.87
574297-7429774.35976.40
673961-7396174.02376.05
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174938-7493875.00076.131.1377.4178.571.11
277126-7712677.19079.63
375529-7552975.59278.05
475821-7582175.88478.31
575953-7595376.01678.47
677024-7702477.08879.53
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%
116.631013291015761015091016131014501014950.12
216.661028071029711028890.12
单位质量响应值RSD%判断
6103.136175.810.84数据可信
供试品溶液-24102102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%
5min118034-1803417.59018.103.4217.5918.103.42
218654-1865418.19418.19
317598-1759817.16417.16
418944-1894418.47718.48
518759-1875918.29718.30
619340-1934018.86418.86
10min129319-2931928.59729.372.8328.6929.472.83
229817-2981729.08229.18
329120-2912028.40328.50
430762-3076230.00430.11
530316-3031629.56929.67
631313-3131330.54230.65
15min137873-3787336.94037.532.5037.2037.792.50
237727-3772736.79837.06
337430-3743036.50836.76
438674-3867437.72137.99
539804-3980438.82339.09
639356-3935638.38638.66
20min142526-4252641.47843.403.8641.9443.883.85
243695-4369542.61843.09
342727-4272741.67442.13
446123-4612344.98745.47
546205-4620545.06745.55
645725-4572544.59845.09
30min152459-5245951.16751.272.0751.8651.982.07
250968-5096849.71250.42
351636-5163650.36451.05
453513-5351352.19552.92
553082-5308251.77452.51
653708-5370852.38553.12
45min157470-5747056.05457.643.1157.0358.643.10
257411-5741155.99756.98
357416-5741656.00156.97
460541-6054159.04960.07
561127-6112759.62160.64
660607-6060759.11460.14
60min163222-6322261.66463.462.1462.9564.782.15
264524-6452462.93464.23
363982-6398262.40663.68
465506-6550663.89265.24
566705-6670565.06266.41
666454-6645464.81766.17
90min169848-6984868.12769.212.1769.7670.882.18
269384-6938467.67569.32
369666-6966667.95069.57
471460-7146069.69971.40
572881-7288171.08572.80
672537-7253770.75072.46
120min175040-7504073.19173.811.9875.2075.861.99
274361-7436172.52974.55
373723-7372371.90773.91
476832-7683274.93977.03
576779-7677974.88776.99
677309-7730975.40477.51
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175657-7565773.79375.222.1876.2177.692.18
276738-7673874.84777.27
375416-7541673.55875.96
476627-7662774.73977.24
578733-7873376.79379.32
679578-7957877.61780.14
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