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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233079773078553078863080163081203079710.04
210.343079333077893078610.04
单位质量响应值RSD%判断
30104.6929773.790.79数据可信
供试品溶液-24082101批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min177933-7793325.95827.605.2325.9627.605.22
279605-7960526.51526.52
380300-8030026.74726.75
489340-8934029.75829.76
585788-8578828.57528.57
684164-8416428.03428.03
10min1210274-21027470.03970.481.4370.3370.791.44
2207020-20702068.95569.25
3209922-20992269.92270.22
4214433-21443371.42471.76
5214617-21461771.48671.80
6213304-21330471.04871.36
15min1258842-25884286.21685.590.6887.2886.680.68
2254221-25422184.67785.74
3256114-25611485.30886.38
4256325-25632585.37886.50
5258267-25826786.02587.14
6258027-25802785.94587.05
20min1277332-27733292.37591.260.7494.4093.300.73
2272010-27201090.60292.60
3272794-27279490.86492.89
4272285-27228590.69492.77
5274852-27485291.54993.62
6274602-27460291.46693.52
30min1289067-28906796.28494.730.9599.3397.780.92
2283402-28340294.39797.41
3282451-28245194.08097.11
4281436-28143693.74296.82
5284665-28466594.81897.90
6285353-28535395.04798.12
45min1291275-29127597.01995.570.97101.1499.680.95
2286243-28624395.34399.40
3284674-28467494.82198.90
4283766-28376694.51898.64
5286612-28661295.46699.60
6288956-28895696.247100.38
60min1290418-29041896.73495.421.05101.93100.591.02
2286116-28611695.301100.42
3283454-28345494.41499.54
4283185-28318594.32599.50
5286197-28619795.328100.53
6289481-28948196.422101.62
极限1291413-29141397.06595.451.12103.34101.681.09
2285839-28583995.209101.38
3282699-28269994.163100.34
4284013-28401394.600100.82
5286392-28639295.393101.65
6288972-28897296.252102.52
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233081043080133079263081133079703080250.03
210.343076133077763076940.04
单位质量响应值RSD%判断
30109.9729757.640.84数据可信
供试品溶液-24082102批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169269-6926923.07725.2811.5323.0825.2811.52
282731-8273127.56227.56
375950-7595025.30225.30
483791-8379127.91527.91
581664-8166427.20627.21
661888-6188820.61820.62
10min1206103-20610368.66370.482.4168.9270.762.43
2215896-21589671.92572.23
3216982-21698272.28772.57
4213619-21361971.16671.48
5212043-21204370.64170.94
6204736-20473668.20768.44
15min1259598-25959886.48486.590.7987.5087.650.81
2261335-26133587.06388.17
3263129-26312987.66188.74
4259142-25914286.33287.43
5258846-25884686.23487.32
6257371-25737185.74286.73
20min1274094-27409491.31391.690.5693.2993.720.58
2275506-27550691.78493.86
3278129-27812992.65894.72
4273945-27394591.26493.32
5275063-27506391.63693.68
6274623-27462391.49093.43
30min1284129-28412994.65794.700.3997.6597.750.39
2283990-28399094.61097.70
3285734-28573495.19198.28
4282485-28248594.10997.18
5285073-28507394.97198.03
6284196-28419694.67997.64
45min1285879-28587995.24095.180.4799.2999.280.47
2285563-28556395.13499.28
3286962-28696295.60099.75
4283687-28368794.50998.63
5287248-28724895.69699.81
6284813-28481394.88498.89
60min1284985-28498594.94294.850.49100.05100.010.48
2284430-28443094.75799.96
3285717-28571795.186100.39
4282410-28241094.08499.25
5286437-28643795.426100.61
6284306-28430694.71699.78
极限1284786-28478694.87594.560.45101.04100.770.45
2283619-28361994.487100.74
3285326-28532695.055101.32
4282127-28212793.990100.20
5284571-28457194.804101.05
6282669-28266994.170100.29
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.233078633079733079713077683079113078970.03
210.343080413081893081150.04
单位质量响应值RSD%判断
30097.4629798.360.71数据可信
供试品溶液-24081501批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min177741-7774125.88730.4715.1025.8930.4715.09
2109470-10947036.45236.45
3103231-10323134.37534.37
474204-7420424.70924.71
590763-9076330.22330.22
693697-9369731.20031.20
10min1222463-22246374.07774.451.7274.3674.791.77
2225639-22563975.13575.54
3228042-22804275.93576.32
4216858-21685872.21172.49
5223276-22327674.34874.68
6225218-22521874.99575.34
15min1266046-26604688.59087.271.2789.7088.441.26
2259203-25920386.31187.55
3264026-26402687.91789.14
4257098-25709885.61086.69
5263325-26332587.68488.85
6262809-26280987.51288.69
20min1281585-28158593.76491.891.4795.8694.031.44
2270848-27084890.18992.39
3276656-27665692.12394.33
4271830-27183090.51692.54
5278540-27854092.75094.89
6276291-27629192.00194.15
30min1291890-29189097.19595.061.59100.3398.221.54
2279221-27922192.97796.18
3284813-28481394.83998.06
4282688-28268894.13197.17
5289255-28925596.31899.48
6285045-28504594.91698.09
45min1294742-29474298.14596.241.55102.36100.461.49
2283217-28321794.30798.54
3287496-28749695.732100.01
4287032-28703295.57899.66
5294016-29401697.903102.14
6287662-28766295.788100.02
60min1293958-29395897.88495.981.51103.19101.261.45
2282668-28266894.12599.41
3286325-28632595.342100.69
4286518-28651895.407100.55
5292956-29295697.550102.88
6286989-28698995.563100.86
极限1293124-29312497.60695.661.58104.00102.001.52
2281472-28147293.726100.05
3284066-28406694.590100.99
4284676-28467694.793101.00
5290733-29073396.810103.22
6289537-28953796.412102.77
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