贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053004423003853003753002123001653003160.05
210.123002223006033004120.09
单位质量响应值RSD%判断
29882.1929684.980.47数据可信
供试品溶液-2010685批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19368-93686.2737.9619.066.277.9619.09
215452-1545210.34710.35
311046-110467.3977.40
413597-135979.1059.11
510191-101916.8246.82
611639-116397.7947.79
10min144223-4422329.61333.557.2429.6833.647.25
249821-4982133.36233.48
349514-4951433.15633.24
455555-5555537.20237.30
551059-5105934.19134.27
650446-5044633.78133.87
15min181099-8109954.30755.872.0654.7156.332.08
285244-8524457.08357.57
382522-8252255.26055.71
483997-8399756.24856.76
585341-8534157.14857.60
682352-8235255.14655.61
20min1100447-10044767.26368.152.2268.2769.232.21
2105707-10570770.78571.91
3100469-10046967.27868.34
4100133-10013367.05368.19
5103280-10328069.16070.25
6100571-10057167.34668.42
30min1119714-11971480.16580.743.1181.9182.583.06
2124921-12492183.65285.56
3121958-12195881.66883.48
4116817-11681778.22580.11
5124115-12411583.11284.97
6115912-11591277.61979.44
45min1131879-13187988.31188.290.9690.9591.020.98
2133817-13381789.60992.44
3131585-13158588.11490.83
4130612-13061287.46390.22
5132655-13265588.83191.61
6130518-13051887.40090.09
60min1135281-13528190.58990.980.5694.2194.700.57
2135448-13544890.70194.53
3136967-13696791.71895.42
4135924-13592491.02094.75
5136547-13654791.43795.21
6135053-13505390.43794.09
极限1140356-14035693.98892.420.9998.6297.150.91
2137843-13784392.30597.14
3136741-13674191.56796.28
4136663-13666391.51596.25
5138496-13849692.74297.53
6138023-13802392.42597.09
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053002883003963003123003293002083003070.03
210.123000293004223002260.10
单位质量响应值RSD%判断
29881.2929666.600.51数据可信
供试品溶液-2010685批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110066-100666.7437.8713.556.747.8713.55
212301-123018.2408.24
312164-121648.1488.15
414409-144099.6529.65
510317-103176.9116.91
611268-112687.5487.55
10min147965-4796532.13033.055.1232.2033.145.14
247306-4730631.68831.78
349524-4952433.17433.26
453624-5362435.92036.03
550685-5068533.95234.03
646959-4695931.45631.54
15min182887-8288755.52255.142.3955.9555.602.37
282239-8223955.08855.53
383262-8326255.77456.23
481588-8158854.65255.16
584904-8490456.87357.33
679038-7903852.94453.38
20min1100053-10005367.02166.783.6368.0767.853.58
2102413-10241368.60269.66
3103051-10305169.02970.11
496028-9602864.32565.44
5102127-10212768.41069.50
694497-9449763.29964.32
30min1119492-11949280.04279.193.3581.8481.003.32
2120997-12099781.05182.87
3121560-12156081.42883.27
4113367-11336775.94077.77
5120903-12090380.98882.83
6113008-11300875.69977.42
45min1128746-12874686.24187.333.2288.9290.023.20
2134787-13478790.28893.01
3133451-13345189.39392.14
4127979-12797985.72888.40
5133338-13333889.31792.06
6123905-12390582.99985.56
60min1134372-13437290.01089.811.0293.6593.470.96
2135927-13592791.05294.77
3131977-13197788.40692.15
4133152-13315289.19392.82
5134379-13437990.01593.75
6134646-13464690.19393.68
极限1132074-13207488.47191.241.9793.1195.901.87
2133813-13381389.63594.37
3139068-13906893.15697.88
4137138-13713891.86396.48
5137540-13754092.13296.87
6137646-13764692.20396.69
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