贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.179653119650309650339654139653179652210.02
211.079629089630519629800.02
单位质量响应值RSD%判断
86411.9186990.060.48数据可信
供试品溶液-24053101s批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1452454-45245446.81340.7510.6646.8140.7510.66
2343178-34317835.50635.51
3351107-35110736.32736.33
4418591-41859143.30943.31
5386318-38631839.97039.97
6411622-41162242.58842.59
10min1824125-82412585.26775.6611.9985.7976.1211.97
2633158-63315865.50965.90
3630275-63027565.21165.61
4802256-80225683.00483.49
5795226-79522682.27782.72
6702816-70281672.71673.19
15min1902337-90233793.35986.187.0994.8387.487.15
2774132-77413280.09581.22
3760664-76066478.70179.83
4877703-87770390.81092.21
5871268-87126890.14591.50
6811793-81179383.99185.27
20min1911393-91139394.29689.595.1896.8091.845.27
2843065-84306587.22789.24
3793026-79302682.04984.05
4903912-90391293.52295.93
5889741-88974192.05694.42
6854440-85444088.40390.62
30min1904451-90445193.57890.623.8697.1393.873.98
2863409-86340989.33192.31
3817925-81792584.62587.54
4897558-89755892.86596.32
5904548-90454893.58896.97
6867441-86744189.74992.95
45min1913095-91309594.47292.464.8599.0696.714.91
2867764-86776489.78293.76
3825784-82578485.43989.29
4948643-94864398.150102.63
5919140-91914095.09899.52
6887481-88748191.82296.02
60min1907990-90799093.94491.313.7899.5996.593.92
2860022-86002288.98193.95
3833231-83323186.20991.01
4917309-91730994.908100.48
5907077-90707793.84999.33
6869695-86969589.98295.20
极限1937381-93738196.98595.292.05103.67101.592.24
2924506-92450695.653101.61
3890012-89001292.08497.85
4927293-92729395.941102.57
5939042-93904297.157103.68
6907796-90779693.924100.14
贝派度酸依折麦布片项目信息
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对照品来源中检院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100
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%
110.072561732559862558972560962560612560430.05
210.032553322556302554810.09
单位质量响应值RSD%判断
25426.3225471.680.13数据可信
供试品溶液-24053101s批-贝派度酸-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min151500-5150020.18017.629.2420.1817.629.24
240491-4049115.86615.87
342057-4205716.48016.48
447209-4720918.49918.50
542141-4214116.51316.51
646412-4641218.18618.19
10min1104897-10489741.10336.538.9141.3336.728.91
283597-8359732.75732.93
385754-8575433.60233.79
499454-9945438.97039.18
596038-9603837.63237.82
689577-8957735.10035.30
15min1128487-12848750.34746.395.1051.0347.005.14
2111644-11164443.74744.29
3115456-11545645.24145.80
4121192-12119247.48848.13
5119358-11935846.77047.37
6114239-11423944.76445.36
20min1142144-14214455.69852.383.5856.9453.503.65
2130591-13059151.17152.20
3129477-12947750.73551.79
4135894-13589453.24954.42
5133475-13347552.30153.42
6130433-13043351.10952.20
30min1157842-15784261.84959.182.4363.7160.882.50
2148656-14865658.25059.84
3149204-14920458.46560.09
4150237-15023758.86960.63
5152310-15231059.68261.38
6147971-14797157.98159.64
45min1176086-17608668.99867.112.6371.5469.462.69
2166675-16667565.31067.55
3167256-16725665.53867.81
4176433-17643369.13471.55
5173140-17314067.84470.21
6167977-16797765.82168.12
60min1186427-18642773.05070.772.3176.3673.872.36
2176861-17686169.30272.27
3180116-18011670.57773.58
4182773-18277371.61874.80
5182364-18236471.45874.58
6175087-17508768.60771.64
极限1195983-19598376.79576.532.1080.9280.421.98
2197727-19772777.47881.22
3199583-19958378.20581.99
4191475-19147575.02879.00
5197860-19786077.53081.44
6189175-18917574.12777.92
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