磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.06 3102943104953103653105533105253104460.04
210.093112033109133110580.07
单位质量响应值RSD%判断
30859.4430828.340.08数据可信
供试品溶液-23K520Z批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1324694-32469495.86994.722.7395.8794.722.73
2335389-33538999.02799.03
3320119-32011994.51994.52
4316940-31694093.58093.58
5309342-30934291.33791.34
6318231-31823193.96193.96
10min1340278-340278100.47199.610.76101.00100.130.77
2340986-340986100.680101.23
3335844-33584499.16299.69
4335504-33550499.06199.58
5335733-33573399.12999.64
6335737-33573799.13099.65
15min1338106-33810699.830100.500.96100.92101.580.96
2344773-344773101.798102.91
3341418-341418100.807101.88
4336502-33650299.356100.43
5338277-33827799.880100.94
6343167-343167101.324102.40
20min1338429-33842999.92599.980.63101.57101.620.63
2340920-340920100.660102.34
3341443-341443100.815102.45
4337623-33762399.687101.31
5336388-33638899.322100.94
6336885-33688599.469101.10
极限1326728-32672896.47099.351.7498.67101.551.70
2337910-33791099.772102.01
3340073-340073100.410102.61
4335165-33516598.961101.14
5335034-33503498.922101.09
6344003-344003101.571103.76
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.06 3113293111813109603105233106253109240.12
210.093141593137973139780.09
单位质量响应值RSD%判断
30906.9631117.740.49数据可信
供试品溶液-23K520Z批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312374-31237491.73294.162.4891.7394.162.48
2321921-32192194.53594.54
3325720-32572095.65195.65
4314967-31496792.49392.49
5315548-31554892.66492.66
6333288-33328897.87497.87
10min1334195-33419598.14098.151.6398.6598.671.63
2339533-33953399.707100.23
3340195-34019599.902100.43
4328195-32819596.37896.89
5327460-32746096.16296.68
6335788-33578898.60899.15
15min1337854-33785499.21499.061.21100.27100.121.21
2343649-343649100.916102.00
3339051-33905199.566100.65
4331355-33135597.30698.36
5336217-33621798.73499.78
6335771-33577198.60399.69
20min1332803-33280397.73198.331.7499.3499.951.72
2339884-33988499.811101.45
3335625-33562598.560100.20
4336024-33602498.677100.27
5324484-32448495.28896.89
6340256-34025699.920101.56
极限1332915-33291597.76497.730.8199.9199.900.79
2336867-33686798.925101.12
3329320-32932096.70898.90
4334475-33447598.222100.36
5332685-33268597.69699.82
6330628-33062897.09299.29
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.06 3111213097843106903103923104463104870.16
210.093127353121453124400.14
单位质量响应值RSD%判断
30863.5230965.310.24数据可信
供试品溶液-23K520Z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%
5min1321827-32182794.80697.011.6594.8197.011.65
2327372-32737296.44096.44
3329436-32943697.04897.05
4336682-33668299.18399.18
5334147-33414798.43698.44
6326380-32638096.14896.15
10min1347336-347336102.321101.011.50102.85101.541.49
2344523-344523101.492102.03
3347335-347335102.321102.86
4342776-342776100.978101.53
5341723-341723100.668101.21
6333532-33353298.25598.79
15min1352066-352066103.714101.691.32104.81102.791.31
2345742-345742101.852102.95
3348886-348886102.778103.89
4341770-341770100.681101.79
5341639-341639100.643101.75
6341046-341046100.468101.55
20min1346289-346289102.013100.761.26103.68102.431.25
2342392-342392100.865102.53
3347753-347753102.444104.12
4337115-33711599.310100.98
5340618-340618100.342102.01
6338119-33811999.606101.24
极限1338291-33829199.65799.282.01101.89101.501.99
2344433-344433101.466103.69
3343506-343506101.193103.44
4335115-33511598.721100.94
5334785-33478598.624100.85
6325981-32598196.03098.22
磷酸奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.06 3109363113003113063108323104993109750.11
210.093106463105803106130.02
单位质量响应值RSD%判断
30912.0330784.240.30数据可信
供试品溶液-23K520Z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%
5min1337654-33765499.68395.544.9699.6895.544.96
2295437-29543787.21987.22
3326048-32604896.25696.26
4315118-31511893.03093.03
5331230-33123097.78697.79
6336303-33630399.28499.28
10min1341409-341409100.791100.431.77101.35100.971.79
2328854-32885497.08597.57
3341911-341911100.940101.47
4339066-339066100.100100.62
5345383-345383101.965102.51
6344571-344571101.725102.28
15min1338764-338764100.010100.302.15101.12101.392.15
2334020-33402098.61099.63
3330346-33034697.52598.62
4339487-339487100.224101.30
5350074-350074103.349104.46
6345787-345787102.084103.20
20min1339651-339651100.272100.631.27101.94102.281.25
2341813-341813100.911102.48
3347041-347041102.454104.09
4334285-33428598.688100.32
5343399-343399101.379103.06
6339011-339011100.083101.77
极限1338427-33842799.91199.580.84102.14101.790.86
2334701-33470198.811100.94
3335521-33552199.053101.26
4334445-33444598.735100.91
5339633-339633100.267102.51
6341193-341193100.728102.97
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