坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231936381937621939481935481940191937830.11
216.231945841943441944640.09
单位质量响应值RSD%判断
11939.8011981.760.25数据可信
供试品溶液-24112901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%
5min117571-175718.29310.0311.468.2910.0311.48
223833-2383311.24911.25
322682-2268210.70510.71
423351-2335111.02111.02
519876-198769.3819.38
620219-202199.5439.54
10min153264-5326425.13929.628.9025.2329.738.90
266441-6644131.35931.48
362120-6212029.31929.44
469866-6986632.97533.10
561782-6178229.16029.26
663047-6304729.75729.86
15min187814-8781441.44646.396.6041.8246.836.61
298346-9834646.41746.89
395358-9535845.00745.45
4107348-10734850.66651.15
599808-9980847.10747.54
6101015-10101547.67748.11
20min1115887-11588754.69657.984.6355.5358.944.66
2124216-12421658.62759.62
3117433-11743355.42656.37
4130923-13092361.79362.84
5121803-12180357.48858.44
6126812-12681259.85260.82
30min1138194-13819465.22568.823.2566.6670.423.31
2145936-14593668.87970.52
3143420-14342067.69169.25
4151209-15120971.36773.11
5146002-14600268.91070.50
6150152-15015270.86872.50
45min1157979-15797974.56376.571.4876.7378.941.56
2161645-16164576.29378.70
3162501-16250176.69779.01
4163447-16344777.14379.67
5162723-16272376.80279.16
6165113-16511377.93080.35
60min1164587-16458777.68178.190.9980.6781.401.06
2163707-16370777.26680.52
3164475-16447577.62980.79
4167012-16701278.82682.21
5166358-16635878.51781.73
6167839-16783979.21682.50
极限1167331-16733178.97779.541.3182.8383.621.33
2165878-16587878.29182.40
3170223-17022380.34284.37
4171984-17198481.17385.44
5167983-16798379.28483.37
6167732-16773279.16683.33
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231951971947061950291951941947551949760.13
216.231990341989301989820.04
单位质量响应值RSD%判断
12013.3112260.141.44数据可信
供试品溶液-24112901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%
5min137561-3756117.47316.254.7317.4716.254.72
233257-3325715.47115.47
335842-3584216.67316.67
433196-3319615.44215.44
534754-3475416.16716.17
634955-3495516.26016.26
10min194869-9486944.13142.024.3244.3342.204.32
288353-8835341.10041.27
395743-9574344.53844.72
486894-8689440.42240.59
588390-8839041.11841.30
687743-8774340.81741.00
15min1133328-13332862.02261.042.5062.7161.692.51
2131040-13104060.95861.59
3136722-13672263.60164.28
4128245-12824559.65760.28
5128721-12872159.87960.52
6129261-12926160.13060.76
20min1150004-15000469.77970.641.7671.1571.971.75
2151376-15137670.41871.72
3155798-15579872.47573.86
4153798-15379871.54472.83
5148302-14830268.98870.29
6151873-15187370.64971.95
30min1162073-16207375.39475.891.4277.5478.001.40
2162364-16236475.52977.62
3164557-16455776.54978.74
4165683-16568377.07379.15
5159425-15942574.16276.23
6164758-16475876.64378.73
45min1166563-16656377.48278.621.2880.4781.581.21
2168289-16828978.28581.21
3168120-16812078.20781.25
4171815-17181579.92582.86
5167755-16775578.03780.93
6171529-17152979.79282.73
60min1168425-16842578.34878.630.8782.2082.460.82
2166651-16665177.52381.32
3168724-16872478.48882.40
4169352-16935278.78082.60
5170678-17067879.39683.16
6170388-17038879.26283.09
极限1172227-17222780.11779.721.4784.8484.421.41
2167144-16714477.75382.41
3171815-17181579.92584.71
4171674-17167479.86084.56
5170546-17054679.33583.98
6174805-17480581.31686.02
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205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(%)0.14对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.232012082002402023202009372026512014710.50
216.232036771969852003312.37
单位质量响应值RSD%判断
12413.4912343.250.41数据可信
供试品溶液-24112901批
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min14075-40751.8581.8413.591.861.8413.72
23294-32941.5021.50
34141-41411.8891.89
44838-48382.2062.21
53556-35561.6221.62
64288-42881.9561.96
20min16347-63472.8952.856.082.922.876.07
26262-62622.8562.87
36298-62982.8722.89
46792-67923.0983.12
55614-56142.5602.58
66158-61582.8082.83
30min18395-83953.8293.705.113.883.755.15
28167-81673.7253.77
37433-74333.3903.44
48570-85703.9083.97
57821-78213.5673.61
68250-82503.7623.82
45min19715-97154.4314.374.194.534.464.19
29990-99904.5564.65
39231-92314.2104.30
49589-95894.3734.48
58981-89814.0964.18
69951-99514.5384.63
60min110926-109264.9834.814.455.134.954.40
210443-104434.7634.90
310786-107864.9195.06
411059-110595.0445.19
59815-98154.4764.61
610253-102534.6764.82
极限110840-108404.9444.963.065.145.163.08
211017-110175.0245.22
311070-110705.0495.24
411270-112705.1405.35
510295-102954.6954.88
610824-108244.9365.13
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