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%
110.063114643114123113913114723113103114100.03
210.093116693122073119380.13
单位质量响应值RSD%判断
30955.2730915.560.10数据可信
供试品溶液-2024051621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%
5min1328527-32852796.71496.366.2396.7196.366.24
2330880-33088097.40797.41
3329378-32937896.96596.96
4308514-30851490.82390.82
5361931-361931106.548106.55
6304783-30478389.72489.72
10min1344939-344939101.546101.994.30102.08102.524.31
2345389-345389101.678102.22
3351630-351630103.515104.05
4337125-33712599.24599.75
5371766-371766109.443110.04
6327744-32774496.48496.98
15min1344497-344497101.416101.744.92102.52102.844.93
2346543-346543102.018103.12
3352086-352086103.650104.76
4334657-33465798.51999.57
5373106-373106109.838111.04
6322717-32271795.00496.04
20min1344059-344059101.287101.573.29102.95103.243.31
2344643-344643101.459103.13
3343422-343422101.099102.79
4345296-345296101.651103.25
5364175-364175107.209109.02
6328567-32856796.72698.29
极限1336079-33607998.93799.253.42101.17101.483.45
2335232-33523298.688100.92
3341902-341902100.652102.90
4331946-33194697.72199.89
5356229-356229104.869107.28
6321471-32147194.63796.74
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%
110.063136843138723138253138013136203137600.04
210.093141593140093140840.04
单位质量响应值RSD%判断
31188.8731128.250.14数据可信
供试品溶液-2024051621批-pH1.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1324281-32428194.78196.162.8994.7896.162.89
2315166-31516692.11792.12
3339359-33935999.18899.19
4330095-33009596.48096.48
5325357-32535795.09595.10
6339755-33975599.30399.30
10min1338718-33871899.000100.851.9499.53101.391.94
2340659-34065999.568100.08
3340311-34031199.466100.02
4350968-350968102.581103.12
5344353-344353100.647101.18
6355362-355362103.865104.42
15min1343552-343552100.413100.961.11101.49102.051.11
2346214-346214101.191102.26
3341531-34153199.822100.93
4344492-344492100.688101.79
5344080-344080100.568101.65
6352593-352593103.056104.18
20min1340023-34002399.382100.381.74101.02102.041.73
2338462-33846298.925100.55
3343079-343079100.275101.93
4338306-33830698.880100.55
5347450-347450101.552103.20
6353345-353345103.275104.98
极限1326514-32651495.433100.333.0897.62102.543.04
2344527-344527100.698102.87
3343865-343865100.505102.72
4344741-344741100.761102.98
5340471-34047199.513101.72
6359548-359548105.088107.36
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%
110.063128703126663127403123033112173123590.22
210.093137153132273134710.12
单位质量响应值RSD%判断
31049.6031067.490.05数据可信
供试品溶液-2024051621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%
5min1317926-31792693.22296.733.3993.2296.723.39
2325203-32520395.35695.36
3328211-32821196.23896.24
4346231-346231101.522101.52
5321162-32116294.17194.17
6340504-34050499.84399.84
10min1332777-33277797.577100.181.3298.09100.711.33
2342408-342408100.401100.93
3342994-342994100.573101.11
4344998-344998101.160101.72
5344673-344673101.065101.59
6342011-342011100.285100.84
15min1331368-33136897.164100.212.3998.22101.302.38
2341426-341426100.113101.20
3339940-33994099.677100.77
4350407-350407102.746103.87
5352038-352038103.225104.31
6335410-33541098.34999.46
20min1335771-33577198.455100.031.14100.05101.681.14
2344998-344998101.160102.80
3340070-34007099.715101.36
4343511-343511100.724102.42
5344758-344758101.090102.75
6337719-33771999.026100.68
极限1334360-33436098.04199.352.03100.19101.562.01
2342509-342509100.431102.64
3331069-33106997.07699.28
4347869-347869102.002104.26
5344026-344026100.875103.10
6333078-33307897.66599.87
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%
110.063137163136733135643134333143483137470.12
210.093149363149153149260.01
单位质量响应值RSD%判断
31187.5731211.690.06数据可信
供试品溶液-2024051621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%
5min1331396-33139696.73398.022.9496.7398.022.94
2343234-343234100.188100.19
3350421-350421102.286102.29
4337312-33731298.45998.46
5323734-32373494.49694.50
6328814-32881495.97995.98
10min1338975-33897598.945100.291.6799.48100.841.68
2351138-351138102.495103.05
3350665-350665102.357102.93
4341276-34127699.617100.16
5338902-33890298.92499.45
6340632-34063299.42999.96
15min1338857-33885798.91099.591.63100.00100.691.64
2345948-345948100.980102.11
3348965-348965101.861103.00
4334103-33410397.52398.62
5341933-34193399.808100.88
6337285-33728598.45299.54
20min1331889-33188996.87798.792.0498.51100.452.04
2345117-345117100.738102.42
3348888-348888101.838103.54
4333349-33334997.30398.94
5336503-33650398.22399.85
6335009-33500997.78799.42
极限1329313-32931396.12598.122.2998.30100.322.28
2343307-343307100.209102.46
3347866-347866101.540103.81
4329478-32947896.17398.36
5332547-33254797.06999.24
6334363-33436397.59999.77
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