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TAAF210008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(%)100.5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%
116.719812898216984349851498380983340.17
216.699942099253993360.12
单位质量响应值RSD%判断
5884.745951.830.81数据可信
供试品溶液-24030101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%
5min132499-3249933.11431.863.7033.1131.863.69
229521-2952130.07930.08
330451-3045131.02731.03
431154-3115431.74331.74
532415-3241533.02833.03
631582-3158232.17932.18
10min155851-5585156.90754.563.0257.0954.743.03
252828-5282853.82753.99
351959-5195952.94253.11
453033-5303354.03654.21
555286-5528656.33156.51
652346-5234653.33653.51
15min164102-6410265.31463.833.2265.8164.313.22
262233-6223363.41063.88
358737-5873759.84860.31
463578-6357864.78065.26
563697-6369764.90165.40
663539-6353964.74065.22
20min169944-6994471.26769.923.3072.1370.753.28
270169-7016971.49672.31
364693-6469365.91666.72
467322-6732268.59569.43
570667-7066772.00372.86
668932-6893270.23571.07
30min175651-7565177.08276.643.3578.3477.863.33
275376-7537676.80178.02
370324-7032471.65472.82
477617-7761779.08580.30
576138-7613877.57878.83
676178-7617877.61878.84
45min183387-8338784.96483.174.4486.6584.824.40
283751-8375185.33586.98
374447-7444775.85577.42
484069-8406985.65987.32
582051-8205183.60385.29
682057-8205783.60985.26
60min187395-8739589.04885.903.8391.2188.013.81
283517-8351785.09687.21
378494-7849479.97881.96
486688-8668888.32790.46
583907-8390785.49487.65
685819-8581987.44289.56
90min190696-9069692.41190.613.4495.0693.203.43
289491-8949191.18393.77
382903-8290384.47186.90
490776-9077692.49395.12
590799-9079992.51695.14
688907-8890790.58893.19
极限188062-8806289.72789.903.1592.8992.993.13
291126-9112692.84995.94
383256-8325684.83087.73
490220-9022091.92695.06
589164-8916490.85093.99
687558-8755889.21492.32
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TAAF210008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(%)100.5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%
116.719834698218982099817598294982480.08
216.699853698726986310.14
单位质量响应值RSD%判断
5879.595909.590.36数据可信
供试品溶液-24030101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%
5min135629-3562936.44835.994.8936.4535.994.89
234243-3424335.03035.03
332116-3211632.85432.85
436215-3621537.04737.05
536294-3629437.12837.13
636584-3658437.42537.42
10min156644-5664457.94657.933.2358.1558.133.24
256568-5656857.86858.06
353168-5316854.39054.57
458240-5824059.57859.78
557163-5716358.47758.68
657994-5799459.32759.53
15min165089-6508966.58566.853.6867.1167.373.67
264948-6494866.44066.96
361757-6175763.17663.66
464305-6430565.78366.32
568556-6855670.13170.66
667425-6742568.97469.51
20min170575-7057572.19771.444.6473.0972.334.63
269696-6969671.29872.18
363549-6354965.00965.84
471067-7106772.70073.60
572746-7274674.41875.34
671365-7136573.00573.93
30min176185-7618577.93676.614.6479.2377.904.62
271714-7171473.36274.64
369431-6943171.02672.22
476664-7666478.42679.73
577895-7789579.68581.02
677425-7742579.20480.53
45min180749-8074982.60481.075.5184.3382.795.48
277363-7736379.14180.83
371394-7139473.03574.63
480808-8080882.66584.41
583785-8378585.71087.49
681411-8141183.28285.05
60min183936-8393685.86586.653.9688.0588.823.95
285136-8513687.09289.22
378921-7892180.73482.73
484724-8472486.67188.87
586527-8652788.51590.77
689002-8900291.04793.28
90min185025-8502586.97986.584.9489.6489.224.91
281035-8103582.89785.51
378297-7829780.09682.54
488175-8817590.20192.88
588958-8895891.00293.75
686310-8631088.29391.03
极限186107-8610788.08685.707.7691.2388.837.62
278274-7827480.07383.15
374115-7411575.81878.71
484817-8481786.76689.95
592036-9203694.15197.40
687329-8732989.33692.56
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