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%
110.063085033075333083973085213081063082120.14
210.093094983085053090020.23
单位质量响应值RSD%判断
30637.3830624.580.03数据可信
供试品溶液-23K520Z批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1321533-32153395.59694.771.3995.6094.781.39
2319531-31953195.00195.00
3324077-32407796.35296.35
4320642-32064295.33195.33
5312889-31288993.02693.03
6313939-31393993.33893.34
10min1349217-349217103.827101.931.99104.36102.461.98
2345025-345025102.581103.11
3348324-348324103.561104.10
4342865-342865101.938102.47
5340984-340984101.379101.90
6330535-33053598.27298.79
15min1352428-352428104.782102.951.93105.89104.041.93
2347300-347300103.257104.35
3350698-350698104.267105.38
4350367-350367104.169105.26
5341681-341681101.586102.67
6335059-33505999.617100.68
20min1352590-352590104.830102.851.58106.52104.521.58
2348353-348353103.570105.24
3345253-345253102.648104.34
4349882-349882104.025105.70
5341584-341584101.557103.20
6337997-337997100.491102.11
极限1343997-343997102.275102.281.31104.55104.511.31
2347886-347886103.431105.68
3348334-348334103.564105.82
4345920-345920102.847105.10
5341402-341402101.503103.71
6336488-336488100.042102.22
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%
110.063074313079723088393078693073713078960.20
210.093090203087243088720.07
单位质量响应值RSD%判断
30605.9630611.690.02数据可信
供试品溶液-23K520Z批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1330226-33022698.25296.023.2398.2596.023.23
2330257-33025798.26198.26
3330073-33007398.20698.21
4304560-30456090.61590.62
5316409-31640994.14194.14
6324798-32479896.63796.64
10min1349457-349457103.973103.170.84104.52103.710.85
2343429-343429102.180102.73
3349703-349703104.047104.59
4343402-343402102.172102.68
5346005-346005102.946103.47
6348578-348578103.712104.25
15min1347378-347378103.355104.040.72104.48105.140.70
2348524-348524103.696104.81
3351780-351780104.665105.79
4353279-353279105.111106.18
5347069-347069103.263104.36
6349983-349983104.130105.24
20min1342478-342478101.897103.141.07103.59104.821.04
2345320-345320102.743104.43
3347937-347937103.521105.23
4353092-353092105.055106.71
5346869-346869103.203104.87
6344150-344150102.394104.09
极限1355561-355561105.790103.691.61108.05105.941.57
2338953-338953100.848103.11
3346134-346134102.985105.26
4350389-350389104.251106.49
5349180-349180103.891106.13
6350798-350798104.372106.63
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%
110.063083073077773083583080273077323080400.10
210.093072483071623072050.02
单位质量响应值RSD%判断
30620.2830446.480.41数据可信
供试品溶液-23K520Z批-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%
5min1327080-32708097.55796.003.1297.5696.003.12
2319502-31950295.29795.30
3326231-32623197.30497.30
4304064-30406490.69290.69
5333428-33342899.45099.45
6320814-32081495.68895.69
10min1342599-342599102.186100.911.60102.73101.451.61
2334126-33412699.658100.19
3342372-342372102.118102.66
4329385-32938598.24498.75
5341629-341629101.896102.45
6339856-339856101.368101.90
15min1339914-339914101.385101.650.99102.49102.750.98
2347453-347453103.633104.72
3339469-339469101.252102.36
4339394-339394101.230102.28
5340548-340548101.574102.69
6338110-338110100.847101.94
20min1341644-341644101.901101.140.86103.57102.790.86
2339244-339244101.185102.84
3334783-33478399.854101.52
4336933-336933100.496102.11
5342628-342628102.194103.88
6339254-339254101.188102.84
极限1339991-339991101.408100.341.62103.65102.561.59
2342702-342702102.216104.44
3329735-32973598.349100.57
4339058-339058101.129103.30
5337179-337179100.569102.82
6329856-32985698.385100.60
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%
110.063068193074353067493065623067533068640.11
210.093070893067213069050.09
单位质量响应值RSD%判断
30503.3830416.750.21数据可信
供试品溶液-23K520Z批-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%
5min1323104-32310496.60294.613.1396.6094.623.13
2317296-31729694.86694.87
3326735-32673597.68897.69
4322693-32269396.47996.48
5302076-30207690.31590.32
6306823-30682391.73591.73
10min1343706-343706102.762100.152.80103.30100.682.80
2337238-337238100.828101.36
3329992-32999298.66299.20
4347179-347179103.800104.34
5323008-32300896.57497.08
6328654-32865498.26298.77
15min1335986-335986100.454100.971.66101.56102.061.65
2333821-33382199.807100.89
3340612-340612101.837102.93
4346607-346607103.629104.74
5338627-338627101.243102.28
6330715-33071598.87899.93
20min1341411-341411102.076100.231.21103.74101.871.21
2332360-33236099.370101.01
3332939-33293999.543101.20
4338504-338504101.207102.90
5330882-33088298.928100.53
6335241-335241100.231101.84
极限1349538-349538104.50699.932.36106.74102.142.32
2332742-33274299.484101.68
3328774-32877498.298100.51
4329873-32987398.626100.88
5329469-32946998.505100.66
6335059-335059100.177102.34
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