盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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 10.722210032208792205132203412203982206270.14
2 10.772202862205902204380.10
单位质量响应值RSD%判断
20580.8820467.780.39数据可信
供试品溶液-2025041521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%
5min1220256-22025696.39192.352.4896.3992.362.48
2210647-21064792.18692.19
3206190-20619090.23590.23
4206744-20674490.47790.48
5213332-21333293.36193.36
6209031-20903191.47891.48
10min1233772-233772102.30699.072.27102.4799.222.27
2225132-22513298.52598.68
3220392-22039296.45096.60
4222257-22225797.26697.42
5231009-231009101.097101.25
6225718-22571898.78198.93
15min1235499-235499103.06199.612.29103.3999.932.29
2226062-22606298.93299.25
3221407-22140796.89497.21
4223795-22379597.93998.25
5231800-231800101.443101.77
6227111-22711199.39199.71
20min1235282-235282102.96799.642.19103.47100.122.19
2226391-22639199.07699.56
3221963-22196397.13897.61
4223851-22385197.96498.44
5231747-231747101.420101.91
6226788-22678899.24999.73
30min1234881-234881102.79199.572.17103.47100.222.17
2226165-22616598.97799.62
3221665-22166597.00797.64
4223653-22365397.87798.52
5231524-231524101.322101.98
6227184-22718499.423100.07
极限1234952-234952102.82299.482.17103.67100.302.17
2225981-22598198.89699.71
3221587-22158796.97397.77
4223793-22379397.93998.74
5231183-231183101.173102.00
6226420-22642099.08899.90
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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 10.722193112195122200682198142196672196740.14
2 10.772196042196692196360.03
单位质量响应值RSD%判断
20491.9820393.310.35数据可信
供试品溶液-2025041521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%
5min1209673-20967392.12692.971.3392.1392.971.33
2213723-21372393.90593.91
3208973-20897391.81891.82
4211269-21126992.82792.83
5216157-21615794.97594.97
6209768-20976892.16792.17
10min1223130-22313098.03898.911.4498.1999.071.44
2226679-22667999.59899.75
3220854-22085497.03897.19
4227121-22712199.79299.95
5229639-229639100.898101.06
6223311-22331198.11898.27
15min1224376-22437698.58699.441.4998.9099.761.50
2227776-227776100.080100.40
3221504-22150497.32497.64
4228621-228621100.451100.77
5230801-230801101.409101.74
6224778-22477898.76399.08
20min1223952-22395298.40099.421.5698.8899.901.56
2227857-227857100.115100.60
3221648-22164897.38797.86
4228935-228935100.589101.08
5230900-230900101.452101.95
6224298-22429898.55299.03
30min1223531-22353198.21599.181.5598.8699.841.54
2227469-22746999.945100.60
3220856-22085697.03997.68
4228884-228884100.567101.22
5229720-229720100.934101.60
6223975-22397598.41099.06
极限1224059-22405998.44799.081.6099.2699.891.60
2227397-22739799.913100.74
3220592-22059296.92397.72
4227719-227719100.055100.88
5230299-230299101.188102.02
6222883-22288397.93098.74
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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 10.722223412218022224652225152220942222430.14
2 10.772220702223102221900.08
单位质量响应值RSD%判断
20731.6220630.450.35数据可信
供试品溶液-2025041621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%
5min1215965-21596593.79792.521.2993.8092.521.28
2207817-20781790.25890.26
3213906-21390692.90292.90
4213415-21341592.68992.69
5213553-21355392.74992.75
6213483-21348392.71992.72
10min1233831-233831101.55699.701.10101.7199.861.10
2226207-22620798.24598.40
3229548-22954899.69699.85
4228612-22861299.28999.44
5228727-22872799.33999.49
6230449-230449100.087100.24
15min1234829-234829101.989100.181.10102.31100.501.10
2227448-22744898.78499.10
3230890-230890100.279100.60
4228926-22892699.42699.75
5230279-230279100.013100.33
6231610-231610100.591100.91
20min1235577-235577102.314100.391.13102.81100.881.13
2228181-22818199.10299.58
3230631-230631100.166100.65
4229486-22948699.669100.15
5230439-230439100.083100.57
6232577-232577101.011101.50
30min1236346-236346102.648100.431.30103.31101.091.30
2227662-22766298.87799.52
3230747-230747100.217100.87
4229515-22951599.681100.33
5230519-230519100.118100.77
6232693-232693101.062101.72
极限1235469-235469102.267100.201.16103.10101.021.16
2228094-22809499.06499.87
3230116-23011699.942100.76
4228793-22879399.368100.19
5229889-22988999.844100.66
6231857-231857100.699101.52
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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 10.722205632210272212562210752201482208140.21
2 10.772215322213542214430.06
单位质量响应值RSD%判断
20598.3220561.100.13数据可信
供试品溶液-2025041621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%
5min1213069-21306992.99491.601.7692.9991.601.75
2207861-20786190.72190.72
3210207-21020791.74591.74
4210259-21025991.76791.77
5213975-21397593.38993.39
6203861-20386188.97588.98
10min1226805-22680598.98998.931.3399.1499.081.33
2224111-22411197.81397.96
3226623-22662398.91099.06
4227157-22715799.14399.30
5231949-231949101.234101.39
6223420-22342097.51297.66
15min1228037-22803799.52799.421.4899.8599.741.48
2224298-22429897.89598.21
3227583-22758399.32999.65
4228463-22846399.713100.03
5233671-233671101.986102.31
6224761-22476198.09798.41
20min1227214-22721499.16799.151.2399.6599.631.23
2225070-22507098.23298.71
3226933-22693399.04599.53
4227580-22758099.32799.81
5232141-232141101.318101.81
6224128-22412897.82198.29
30min1227666-22766699.36599.161.33100.0299.811.33
2223936-22393697.73798.38
3226187-22618798.71999.37
4228063-22806399.538100.19
5232434-232434101.446102.11
6224920-22492098.16698.80
极限1226964-22696499.05898.941.4999.8899.761.49
2224257-22425797.87798.68
3226179-22617998.71699.53
4227379-22737999.239100.06
5232569-232569101.505102.34
6222808-22280897.24498.05
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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 10.722220062208672216612219612216332216260.21
2 10.772214642217292215960.09
单位质量响应值RSD%判断
20674.0720575.300.34数据可信
供试品溶液-2025041821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%
5min1211716-21171692.20292.910.7992.2092.910.79
2215147-21514793.69793.70
3213239-21323992.86692.87
4214474-21447493.40393.40
5211031-21103191.90491.90
6214491-21449193.41193.41
10min1226668-22666898.714100.481.1298.87100.641.12
2233193-233193101.556101.71
3231715-231715100.912101.07
4231625-231625100.873101.03
5228524-22852499.52299.68
6232678-232678101.331101.49
15min1226723-22672398.738100.941.2999.06101.261.29
2234444-234444102.100102.43
3233285-233285101.596101.92
4232133-232133101.094101.42
5229909-229909100.125100.44
6234158-234158101.976102.30
20min1226667-22666798.713100.921.3299.20101.411.32
2234262-234262102.021102.52
3233492-233492101.686102.18
4231989-231989101.031101.52
5229636-229636100.006100.49
6234310-234310102.042102.54
30min1227371-22737199.020100.871.1999.67101.531.19
2233858-233858101.845102.51
3233498-233498101.688102.35
4231934-231934101.007101.67
5229181-22918199.808100.46
6233846-233846101.840102.50
极限1226680-22668098.719100.771.4099.53101.591.39
2233442-233442101.664102.50
3233762-233762101.803102.63
4231561-231561100.845101.67
5228271-22827199.412100.23
6234582-234582102.160102.99
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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 10.722222222219062224152221762220732221580.09
2 10.772217382220372218880.10
单位质量响应值RSD%判断
20723.6920602.410.42数据可信
供试品溶液-2025041821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%
5min1200209-20020987.02990.032.3587.0390.032.35
2203591-20359188.50088.50
3210940-21094091.69491.69
4210631-21063191.56091.56
5212313-21231392.29192.29
6205051-20505189.13489.13
10min1225727-22572798.12299.661.6898.2799.811.68
2225651-22565198.08998.24
3230043-23004399.998100.15
4230358-230358100.135100.29
5235903-235903102.545102.70
6227884-22788499.05999.21
15min1227752-22775299.002100.391.7599.31100.701.75
2228124-22812499.16499.47
3231535-231535100.647100.97
4231682-231682100.710101.03
5238344-238344103.606103.93
6228212-22821299.20299.52
20min1228348-22834899.261100.501.7599.73100.981.75
2227626-22762698.94799.42
3231570-231570100.662101.15
4231947-231947100.826101.31
5238602-238602103.719104.22
6229064-22906499.572100.05
30min1228179-22817999.188100.531.7199.83101.181.71
2228485-22848599.32199.96
3231401-231401100.588101.24
4231422-231422100.597101.25
5238800-238800103.805104.47
6229318-22931899.683100.33
极限1227005-22700598.677100.331.7499.48101.151.74
2228677-22867799.404100.21
3230699-230699100.283101.11
4230964-230964100.398101.22
5238410-238410103.635104.48
6229070-22907099.575100.39
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