多替诺雷片项目信息
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D241101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(%)99.69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%
110.196536365325654826546065499654260.12
210.206657266620665960.06
单位质量响应值RSD%判断
6420.616529.021.19数据可信
供试品溶液-25041501批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17398-739810.25210.1417.6010.2510.1417.61
26959-69599.6449.64
35776-57768.0048.00
49056-905612.55012.55
56193-61938.5828.58
68539-853911.83311.83
10min114509-1450920.10619.929.0420.1219.939.05
214091-1409119.52719.54
312794-1279417.73017.74
416187-1618722.43222.45
513198-1319818.29018.30
615451-1545121.41221.43
15min119186-1918626.58826.305.7626.6426.355.77
218875-1887526.15726.21
317484-1748424.22924.27
420344-2034428.19328.25
518031-1803124.98725.03
619931-1993127.62027.68
20min122591-2259131.30631.294.2131.4031.394.22
222661-2266131.40331.50
321184-2118429.35729.44
423704-2370432.84932.95
521876-2187630.31630.40
623472-2347232.52732.63
30min127014-2701437.43637.653.0837.5837.803.09
227337-2733737.88338.03
326026-2602636.06736.20
428322-2832239.24839.41
526529-2652936.76436.90
627793-2779338.51538.67
45min131699-3169943.92843.902.5344.1444.122.55
231775-3177544.03344.24
330441-3044142.18542.38
432814-3281445.47345.70
531244-3124443.29843.50
632116-3211644.50644.73
60min134702-3470248.09048.131.8048.3748.411.83
234862-3486248.31148.59
333878-3387846.94847.21
435659-3565949.41649.72
534233-3423347.44047.71
635043-3504348.56248.86
90min138382-3838253.18953.661.6053.5554.021.62
238905-3890553.91454.28
337986-3798652.64152.98
439764-3976455.10555.49
538406-3840653.22353.57
638870-3887053.86654.24
120min141389-4138957.35657.301.6857.8157.751.70
241607-4160757.65958.11
340363-4036355.93556.36
442347-4234758.68459.16
540801-4080156.54256.98
641588-4158857.63258.10
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142463-4246358.84558.731.0259.3959.281.03
242680-4268059.14559.69
341733-4173357.83358.35
442733-4273359.21959.79
541972-4197258.16458.70
642714-4271459.19359.75
多替诺雷片项目信息
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D241101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(%)99.69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%
110.196549165631655036558065306655020.19
210.206569765729657130.04
单位质量响应值RSD%判断
6428.076442.450.16数据可信
供试品溶液-25041801批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18390-839011.69711.0312.4011.7011.0312.42
28885-888512.38812.39
38446-844611.77611.78
48320-832011.60011.60
56343-63438.8438.84
67066-70669.8519.85
10min114841-1484120.69120.417.2420.7120.427.26
215571-1557121.70921.73
315176-1517621.15921.18
415555-1555521.68721.71
513025-1302518.16018.17
613652-1365219.03419.05
15min119345-1934526.97126.764.0327.0226.814.04
219709-1970927.47927.54
319535-1953527.23627.29
420050-2005027.95428.01
518032-1803225.14025.19
618485-1848525.77225.82
20min122354-2235431.16631.303.2931.2731.393.30
222999-2299932.06532.17
323091-2309132.19432.29
423060-2306032.15132.25
521314-2131429.71629.80
621868-2186830.48930.58
30min126646-2664637.15037.422.3637.3037.572.37
227393-2739338.19238.35
327406-2740638.21038.36
427278-2727838.03138.19
525830-2583036.01236.15
626503-2650336.95137.09
45min130703-3070342.80643.361.6043.0243.571.61
231569-3156944.01444.23
331482-3148243.89344.11
431549-3154943.98644.21
530444-3044442.44542.64
630834-3083442.98943.19
60min133807-3380747.13447.761.4347.4248.051.45
234701-3470148.38148.67
334692-3469248.36848.66
434539-3453948.15548.45
533529-3352946.74747.01
634286-3428647.80248.08
90min137234-3723451.91253.041.4552.2753.411.45
238509-3850953.69054.06
338308-3830853.40953.78
438427-3842753.57553.95
537466-3746652.23652.58
638332-3833253.44353.80
120min140312-4031256.20356.781.0956.6557.241.10
241152-4115257.37557.84
341169-4116957.39857.86
440864-4086456.97357.43
540085-4008555.88756.32
640785-4078556.86357.31
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141275-4127557.54658.370.9658.0958.910.96
242223-4222358.86859.43
341986-4198658.53759.09
442165-4216558.78759.34
541454-4145457.79658.32
642083-4208358.67359.21
多替诺雷片项目信息
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D241101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(%)99.69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%
110.196610366118660366597966056660580.09
210.206681166767667890.05
单位质量响应值RSD%判断
6482.636547.940.71数据可信
供试品溶液-25041802批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18019-801911.0439.5516.5711.049.5516.55
28107-810711.16411.16
35692-56927.8397.84
47123-71239.8099.81
57284-728410.03110.03
65400-54007.4367.44
10min115118-1511820.81919.149.2420.8419.169.25
214644-1464420.16720.19
312519-1251917.24017.25
414466-1446619.92119.94
514596-1459620.10020.12
612035-1203516.57416.59
15min119612-1961227.00825.565.2627.0625.615.27
219271-1927126.53826.59
317710-1771024.38924.43
418786-1878625.87125.92
518913-1891326.04526.10
617063-1706323.49823.54
20min122569-2256931.08030.103.1131.1830.183.13
222385-2238530.82730.92
321342-2134229.39029.47
421839-2183930.07530.17
522198-2219830.56930.66
620791-2079128.63228.71
30min127483-2748337.84736.472.3938.0036.622.40
226713-2671336.78736.93
325843-2584335.58935.72
426606-2660636.64036.78
526506-2650636.50236.65
625765-2576535.48135.61
45min131449-3144943.30942.671.1843.5242.871.20
230897-3089742.54942.76
330803-3080342.41942.61
431278-3127843.07443.28
531062-3106242.77642.98
630419-3041941.89142.08
60min134208-3420847.10846.740.9847.3947.010.99
233643-3364346.33046.61
333963-3396346.77147.03
434185-3418547.07747.35
534199-3419947.09647.37
633427-3342746.03346.29
90min138963-3896353.65752.481.3154.0252.831.31
237654-3765451.85452.21
337848-3784852.12152.46
437765-3776552.00752.36
538434-3843452.92853.28
638001-3800152.33252.66
120min141130-4113056.64156.051.0957.0956.491.08
239861-3986154.89355.34
340890-4089056.31056.74
440716-4071656.07156.51
540937-4093756.37556.82
640669-4066956.00656.43
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142069-4206957.93457.390.8158.4857.920.81
241116-4111656.62257.16
341790-4179057.55058.07
441652-4165257.36057.89
541902-4190257.70458.24
641505-4150557.15757.67
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