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%
116.519559495571954859536195368954760.12
216.439645296435964440.02
单位质量响应值RSD%判断
5782.925869.991.06数据可信
供试品溶液-24110801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%
5min113527-1352713.90313.821.6913.9013.821.71
213619-1361913.99714.00
313405-1340513.77713.78
413196-1319613.56313.56
513178-1317813.54413.54
613735-1373514.11714.12
10min125657-2565726.37027.052.1726.4527.132.16
225789-2578926.50626.58
326048-2604826.77226.85
426567-2656727.30527.38
526994-2699427.74427.82
626878-2687827.62527.70
15min135054-3505436.02836.471.7836.2536.701.78
234576-3457635.53735.76
335640-3564036.63036.86
436030-3603037.03137.26
535328-3532836.31036.54
636277-3627737.28537.52
20min141062-4106242.20342.902.2142.6343.332.21
240787-4078741.92042.34
341022-4102242.16242.59
442970-4297044.16444.60
541980-4198043.14643.58
642634-4263443.81944.26
30min149926-4992651.31351.882.1951.9752.552.18
248825-4882550.18250.84
350958-5095852.37453.04
452074-5207453.52154.20
550154-5015451.54752.22
650913-5091352.32853.01
45min158182-5818259.79860.862.0560.7461.812.04
258263-5826359.88260.82
360499-6049962.18063.13
460267-6026761.94162.92
557900-5790059.50960.47
660155-6015561.82662.80
60min164025-6402565.80466.142.8667.0867.442.82
263908-6390865.68466.95
361540-6154063.25064.55
466980-6698068.84170.16
564055-6405565.83567.12
665625-6562567.44868.76
90min169892-6989271.83472.981.2573.4874.641.26
269998-6999871.94373.57
371780-7178073.77475.43
471747-7174773.74075.44
570911-7091172.88174.53
671722-7172273.71575.41
120min176474-7647478.59979.241.1280.6481.301.12
276890-7689079.02681.06
377243-7724379.38981.45
478394-7839480.57282.68
575959-7595978.06980.13
677608-7760879.76481.87
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176222-7622278.34079.512.2680.8282.012.21
276887-7688779.02381.49
379328-7932881.53284.03
479399-7939981.60584.16
574985-7498577.06879.56
677327-7732779.47582.02
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%
116.514748247519473754744047469474570.12
216.434804548066480560.04
单位质量响应值RSD%判断
2874.442924.891.24数据可信
供试品溶液-24102101-2-1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%
5min17526-752615.54315.161.9915.5415.161.98
27208-720814.88614.89
37322-732215.12215.12
47481-748115.45015.45
57362-736215.20415.20
67157-715714.78114.78
10min112975-1297526.79627.211.4826.8827.301.47
213147-1314727.15127.23
313055-1305526.96127.05
413085-1308527.02327.11
513295-1329527.45727.54
613509-1350927.89927.98
15min117622-1762236.39336.642.2636.6336.882.25
217795-1779536.75136.98
317174-1717435.46835.70
417490-1749036.12136.36
518249-1824937.68837.93
618118-1811837.41837.65
20min120905-2090543.17344.172.0243.6144.612.00
221247-2124743.88044.32
321692-2169244.79945.23
420925-2092543.21543.65
521621-2162144.65245.10
621948-2194845.32745.77
30min125904-2590453.49753.372.1254.1754.062.11
225575-2557552.81853.50
325292-2529252.23452.91
425438-2543852.53553.21
526060-2606053.82054.51
626793-2679355.33356.03
45min131722-3172265.51363.172.4466.4964.152.41
230047-3004762.05463.03
329811-2981161.56662.54
430031-3003162.02162.99
531022-3102264.06765.06
630883-3088363.78064.78
60min133214-3321468.59469.612.2969.9370.942.27
233854-3385469.91671.24
332581-3258167.28768.60
433531-3353169.24970.56
534350-3435070.94072.29
634705-3470571.67473.03
90min136963-3696376.33775.201.3678.0676.921.35
235678-3567873.68375.39
336062-3606274.47676.16
436495-3649575.37077.07
536904-3690476.21577.96
636364-3636475.10076.86
120min140119-4011982.85581.271.5685.0083.401.53
239092-3909280.73482.85
338868-3886880.27182.37
439258-3925881.07683.19
540079-4007982.77284.94
638691-3869179.90582.08
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139372-3937281.31282.232.1183.9284.822.06
238854-3885480.24282.81
339090-3909080.73083.27
440954-4095484.57987.15
540487-4048783.61586.24
640151-4015182.92185.54
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