坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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4000
标示量(mg)4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%
1 16.103825738270384183839038332383330.19
216.123884338861388520.04
单位质量响应值RSD%判断
2380.932410.170.87数据可信
供试品溶液-KF021批-pH6.5(内含0.35%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19002-900221.09620.1617.9421.1020.1717.94
26993-699316.38816.39
310443-1044324.47324.47
46456-645615.13015.13
59361-936121.93721.94
69373-937321.96621.97
10min126565-2656562.25555.0416.1162.2955.0816.11
219748-1974846.27946.31
328119-2811965.89765.94
418528-1852843.42043.45
524862-2486258.26458.30
623096-2309654.12554.16
15min138737-3873790.78082.7112.5490.9282.8412.55
231860-3186074.66474.77
339858-3985893.40793.56
428515-2851566.82566.92
537976-3797688.99689.13
634811-3481181.57981.71
20min142291-4229199.10995.466.1199.4095.736.13
239020-3902091.44391.67
342421-4242199.41399.72
436532-3653285.61285.82
542926-42926100.597100.88
641225-4122596.61096.87
30min142915-42915100.571101.082.19101.03101.502.20
243871-43871102.811103.19
342922-42922100.587101.06
441471-4147197.18797.54
544069-44069103.275103.73
643534-43534102.022102.45
45min143377-43377101.654101.521.43102.28102.111.44
243760-43760102.551103.10
342768-42768100.226100.87
442393-4239399.34899.86
543983-43983103.074103.70
643642-43642102.275102.87
60min142903-42903100.543101.281.30101.34102.041.30
243535-43535102.024102.75
342696-42696100.058100.86
442649-4264999.948100.63
544057-44057103.247104.04
643476-43476101.886102.65
极限142508-4250899.617101.321.27100.58102.251.23
243602-43602102.181103.07
342585-4258599.798100.77
443803-43803102.652103.50
543465-43465101.860102.83
643443-43443101.808102.74
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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4000
标示量(mg)4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%
1 16.103845238484386553847638527385190.21
216.123878039028389040.46
单位质量响应值RSD%判断
2392.482413.400.62数据可信
供试品溶液-KF021批-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13589-35898.3858.8612.998.388.8613.01
24698-469810.97610.98
33660-36608.5518.55
43447-34478.0538.05
53371-33717.8757.88
63979-39799.2969.30
10min112858-1285830.03930.4113.3630.0530.4313.35
215962-1596237.29137.31
312686-1268629.63829.65
411477-1147726.81326.83
511237-1123726.25226.27
613890-1389032.45032.47
15min123303-2330354.44153.4512.9854.5153.5212.99
227594-2759464.46664.55
322291-2229152.07752.14
419774-1977446.19746.25
519852-1985246.37946.44
624470-2447057.16857.24
20min132402-3240275.69972.3611.2675.8572.5211.26
235643-3564383.27183.46
330034-3003470.16770.32
427027-2702763.14263.28
527230-2723063.61663.75
633505-3350578.27678.44
30min141012-4101295.81491.635.3296.0991.905.34
241119-4111996.06496.39
337961-3796188.68688.95
436406-3640685.05385.29
537779-3777988.26188.50
641052-4105295.90796.20
45min143744-43744102.19799.412.27102.6499.842.28
242838-42838100.080100.57
341414-4141496.75397.17
441419-4141996.76597.15
542598-4259899.51999.91
643287-43287101.129101.58
60min143946-43946102.669100.711.94103.28101.311.94
243038-43038100.547101.20
342029-4202998.19098.77
442198-4219898.58599.13
543639-43639101.951102.50
643806-43806102.341102.97
极限143714-43714102.127100.971.12102.91101.731.12
242914-42914100.258101.08
342474-4247499.23099.97
443245-43245101.031101.74
543225-43225100.984101.71
643737-43737102.180102.97
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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4000
标示量(mg)4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%
1 16.103900638921389553912838773389570.34
216.123963839365395020.49
单位质量响应值RSD%判断
2419.692450.500.90数据可信
供试品溶液-KF021批-pH4.5(内含1.0%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13038-30387.0047.066.247.007.066.25
23190-31907.3547.35
33322-33227.6597.66
43000-30006.9166.92
52756-27566.3546.35
63070-30707.0787.08
15min17290-729016.80716.226.7916.8216.236.80
26983-698316.09916.11
37757-775717.88317.90
47074-707416.30916.32
56343-634314.62314.63
66768-676815.60315.62
20min111559-1155926.64926.387.9026.6926.427.91
211343-1134326.15126.19
313067-1306730.12530.17
411154-1115425.71525.75
510305-1030523.75823.79
611237-1123725.90625.94
30min118744-1874443.21342.912.6743.3042.992.67
218227-1822742.02142.10
319183-1918344.22544.32
419177-1917744.21244.29
518062-1806241.64141.72
618275-1827542.13242.21
45min126129-2612960.23959.871.6960.4060.031.70
225462-2546258.70158.85
326610-2661061.34861.51
426133-2613360.24860.40
525482-2548258.74758.89
626006-2600659.95560.11
60min130671-3067170.71070.671.1470.9770.931.15
230697-3069770.77071.02
331229-3122971.99772.27
430612-3061270.57470.83
530582-3058270.50570.75
630138-3013869.48269.73
极限132435-3243574.77776.441.5175.1576.811.52
232898-3289875.84576.21
333791-3379177.90378.29
433656-3365677.59277.97
533050-3305076.19576.55
633110-3311076.33376.70
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