依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113757163784763775373771653779703773730.28
210.933754963758803756880.08
单位质量响应值RSD%判断
34306.6434372.190.14数据可信
供试品溶液-X013576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%
5min110015-100152.6252.3114.412.622.3114.36
29203-92032.4122.41
39929-99292.6022.60
49266-92662.4292.43
57627-76271.9992.00
66911-69111.8111.81
10min124903-249036.5276.484.856.536.484.88
225047-250476.5656.57
326231-262316.8756.88
425365-253656.6486.65
523868-238686.2566.26
622824-228245.9825.98
15min128742-287427.5337.643.367.557.663.37
229544-295447.7437.76
329788-297887.8077.82
430579-305798.0148.03
527947-279477.3257.34
628382-283827.4397.45
20min130327-303277.9487.942.407.987.972.42
230463-304637.9848.01
330861-308618.0888.12
431163-311638.1688.20
529122-291227.6337.66
629892-298927.8347.86
30min128228-282287.3987.783.567.447.823.58
229746-297467.7967.84
330550-305508.0078.05
431146-311468.1638.21
529057-290577.6167.65
629286-292867.6767.71
45min127588-275887.2317.733.607.287.783.61
229546-295467.7447.80
330558-305588.0098.06
430407-304077.9698.03
529316-293167.6837.73
629613-296137.7617.81
60min128837-288377.5587.793.577.627.863.54
229227-292277.6607.73
331690-316908.3068.37
429772-297727.8037.87
528907-289077.5767.64
629961-299617.8527.92
极限128131-281317.3737.733.287.457.803.28
229220-292207.6587.74
330643-306438.0318.11
430506-305067.9958.08
528870-288707.5677.64
629504-295047.7337.81
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1113775063793153810313820793800673800000.46
210.933763713768753766230.10
单位质量响应值RSD%判断
34545.4534457.730.18数据可信
供试品溶液-X013576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%
5min18143-81432.1242.1813.932.122.1813.87
26784-67841.7701.77
39167-91672.3912.39
49869-98692.5742.57
57314-73141.9081.91
68825-88252.3022.30
10min123547-235476.1426.054.236.156.054.24
222287-222875.8145.82
324896-248966.4946.50
422675-226755.9155.92
522369-223695.8355.84
623320-233206.0836.09
15min127119-271197.0747.262.577.097.272.59
228694-286947.4857.50
328641-286417.4717.49
427439-274397.1587.17
527910-279107.2817.29
627138-271387.0797.09
20min129240-292407.6277.432.077.657.462.05
229112-291127.5947.62
328539-285397.4457.47
427738-277387.2367.26
528145-281457.3427.37
628178-281787.3507.38
30min129939-299397.8107.563.727.857.593.70
228927-289277.5467.58
329489-294897.6927.73
427493-274937.1727.21
530071-300717.8447.88
627884-278847.2747.31
45min129203-292037.6187.372.327.677.422.32
228542-285427.4457.50
328690-286907.4847.54
427556-275567.1887.24
527831-278317.2607.31
627711-277117.2297.28
60min129698-296987.7477.413.987.817.483.97
228486-284867.4317.49
329448-294487.6827.75
428609-286097.4637.52
526715-267156.9697.03
627568-275687.1917.25
极限128542-285427.4457.443.647.527.523.64
228127-281277.3377.41
330126-301267.8597.94
427693-276937.2247.30
529326-293267.6507.72
627374-273747.1417.21
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