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%
116.679927599313991029900899053991500.14
216.73999261000751000000.11
单位质量响应值RSD%判断
5947.815977.290.35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%
5min117360-1736017.43415.9810.5317.4315.9810.51
214059-1405914.11914.12
313508-1350813.56613.57
416692-1669216.76316.76
516763-1676316.83516.83
617088-1708817.16117.16
10min139233-3923339.40137.424.1639.5037.514.17
235051-3505135.20135.28
336025-3602536.17936.25
437373-3737337.53337.63
538539-3853938.70438.80
637364-3736437.52437.62
15min152423-5242352.64750.122.7752.9650.412.77
248594-4859448.80249.08
349600-4960049.81250.09
449362-4936249.57349.87
550426-5042650.64250.95
649019-4901949.22949.53
20min159596-5959659.85158.452.0660.4659.022.05
259247-5924759.50060.05
357857-5785758.10458.66
457020-5702057.26457.84
558773-5877359.02459.61
656699-5669956.94157.52
30min167099-6709967.38667.032.4068.3367.932.39
264408-6440864.68365.56
366465-6646566.74967.63
465587-6558765.86766.76
568315-6831568.60769.52
668572-6857268.86569.76
45min171619-7161971.92572.181.9773.2473.461.96
270173-7017370.47371.71
371761-7176172.06873.31
470678-7067870.98072.24
573824-7382474.14075.44
673200-7320073.51374.79
60min177346-7734677.67778.081.1479.3979.751.14
277044-7704477.37379.00
377489-7748977.82079.47
477000-7700077.32978.98
578373-7837378.70880.42
679231-7923179.57081.25
90min183177-8317783.53382.481.5985.6884.591.54
281382-8138281.73083.79
383765-8376584.12386.20
482457-8245782.80984.89
581855-8185582.20584.35
680146-8014680.48982.62
120min182774-8277483.12882.213.5485.7484.783.45
279940-7994080.28282.79
383952-8395284.31186.86
483232-8323283.58886.13
584397-8439784.75887.36
676890-7689077.21979.79
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186743-8674387.11485.372.6690.1988.402.60
280527-8052780.87183.83
386198-8619886.56689.58
485798-8579886.16589.17
585401-8540185.76688.84
685399-8539985.76488.77
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%
116.679942699395992359920699223992970.11
216.739928399241992620.03
单位质量响应值RSD%判断
5956.635933.170.28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%
5min120069-2006920.21519.636.7220.2119.626.71
218605-1860518.74018.74
320135-2013520.28120.28
417861-1786117.99117.99
518782-1878218.91818.92
621457-2145721.61321.61
10min138977-3897739.26040.034.3339.3740.144.33
236896-3689637.16437.27
339792-3979240.08140.19
439862-3986240.15140.25
541225-4122541.52441.63
641715-4171542.01842.14
15min148375-4837548.72650.403.8249.0650.733.81
248912-4891249.26749.58
348333-4833348.68449.02
449760-4976050.12150.44
552374-5237452.75453.09
652438-5243852.81853.17
20min157863-5786358.28358.352.1658.8858.962.17
256975-5697557.38857.97
358035-5803558.45659.06
456985-5698557.39858.00
557428-5742857.84558.47
660321-6032160.75961.41
30min164579-6457965.04767.562.5865.9768.492.57
266408-6640866.89067.79
366428-6642866.91067.84
466999-6699967.48568.41
568620-6862069.11870.07
669394-6939469.89770.88
45min172419-7241972.94472.271.9874.2373.581.99
269638-6963870.14371.42
371786-7178672.30773.61
470905-7090571.41972.71
571904-7190472.42673.76
673847-7384774.38375.76
60min175200-7520075.74577.681.7877.4479.391.78
277041-7704177.60079.26
376781-7678177.33879.04
477007-7700777.56679.26
577224-7722477.78479.52
679469-7946980.04581.83
90min181207-8120781.79682.301.8983.9184.441.89
280042-8004280.62382.72
380098-8009880.67982.81
483069-8306983.67285.79
582031-8203182.62684.79
683787-8378784.39586.63
120min180992-8099281.57983.642.2384.1586.242.22
281587-8158782.17984.72
381902-8190282.49685.08
483453-8345384.05886.65
584673-8467385.28787.91
685625-8562586.24688.95
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183561-8356184.16784.981.9587.1988.041.95
283319-8331983.92386.92
383434-8343484.03987.08
485069-8506985.68688.74
583388-8338883.99387.09
687433-8743388.06791.25
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%
116.679979399670993749932199386995090.22
216.739962599800997120.13
单位质量响应值RSD%判断
5969.355960.070.12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%
5min123514-2351423.60624.653.4323.6124.653.43
223829-2382923.92223.92
325436-2543625.53525.54
424167-2416724.26124.26
524883-2488324.98024.98
625502-2550225.60225.60
10min140584-4058440.74241.311.7940.8741.441.80
240420-4042040.57840.71
341839-4183942.00242.14
440447-4044740.60540.74
541645-4164541.80841.95
641946-4194642.11042.25
15min151679-5167951.88152.132.6052.2452.502.58
250693-5069350.89151.25
350417-5041750.61450.99
452123-5212352.32752.69
552555-5255552.76053.13
654107-5410754.31854.69
20min158596-5859658.82559.381.4659.4760.041.46
258841-5884159.07159.71
357846-5784658.07258.73
459743-5974359.97660.63
559998-5999860.23260.90
659874-5987460.10860.79
30min167644-6764467.90867.761.4968.8868.751.47
266012-6601266.27067.24
368580-6858068.84869.83
467612-6761267.87668.86
568475-6847568.74269.74
666677-6667766.93767.95
45min174142-7414274.43274.201.9975.7875.561.97
271963-7196372.24473.58
373171-7317173.45774.82
473318-7331873.60474.97
576263-7626376.56177.94
674603-7460374.89476.28
60min177104-7710477.40578.142.4479.1779.912.41
277671-7767177.97479.71
374603-7460374.89476.66
478415-7841578.72180.49
580025-8002580.33882.14
679203-7920379.51281.31
90min180080-8008080.39382.013.7382.5984.223.67
277108-7710877.40979.58
381181-8118181.49883.68
481837-8183782.15784.36
585637-8563785.97188.22
684323-8432384.65286.89
120min185292-8529285.62583.583.2688.2786.243.19
282478-8247882.80085.40
378101-7810178.40681.04
484054-8405484.38287.05
584539-8453984.86987.60
685050-8505085.38288.09
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186488-8648886.82686.671.6789.9489.801.65
283878-8387884.20687.27
387526-8752687.86890.94
485412-8541285.74688.88
587332-8733287.67390.87
687354-8735487.69590.88
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