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%
19.923030633029383030383031453032683030900.05
29.943027203040023033610.30
单位质量响应值RSD%判断
30553.4330519.220.08数据可信
加速6月-供试品溶液-2024051421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%
5min1293561-29356187.55090.584.9587.5590.584.95
2313148-31314893.39293.39
3324102-32410296.65996.66
4311040-31104092.76392.76
5297489-29748988.72288.72
6282996-28299684.39984.40
10min1313221-31322193.41395.681.8893.9096.181.89
2329039-32903998.13198.65
3321618-32161895.91896.45
4326343-32634397.32797.84
5317550-31755094.70595.20
6317069-31706994.56195.03
15min1314538-31453893.80695.711.5594.8196.751.56
2327174-32717497.57598.64
3324641-32464196.81997.89
4320130-32013095.47496.53
5323039-32303996.34297.36
6316076-31607694.26595.26
20min1311947-31194793.03495.481.7394.5697.041.73
2323434-32343496.45998.07
3328505-32850597.97299.58
4319005-31900595.13896.72
5319145-31914595.18096.73
6318842-31884295.09096.61
极限1316874-31687494.50395.010.9696.5597.100.99
2321607-32160795.91498.06
3322258-32225896.10998.26
4318955-31895595.12497.24
5317539-31753994.70196.78
6314131-31413193.68595.73
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%
19.923039863040703045723029153022213035530.32
29.943034523035243034880.02
单位质量响应值RSD%判断
30600.1030531.990.16数据可信
加速6月-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%
5min1299025-29902589.09390.172.1089.0990.172.10
2300140-30014089.42589.43
3305001-30500190.87490.87
4314440-31444093.68693.69
5297206-29720688.55188.55
6300042-30004289.39689.40
10min1321502-32150295.79096.081.0796.2896.581.07
2317717-31771794.66295.16
3323533-32353396.39596.90
4327920-32792097.70298.22
5320588-32058895.51896.01
6323579-32357996.40996.91
15min1324663-32466396.73296.451.3697.7697.481.35
2318862-31886295.00396.03
3318078-31807894.77095.81
4328511-32851197.87898.94
5324409-32440996.65697.68
6327728-32772897.64598.68
20min1320585-32058595.51796.212.0397.0897.782.01
2318490-31849094.89396.44
3318019-31801994.75296.32
4335651-335651100.006101.61
5321539-32153995.80197.36
6323247-32324796.31097.88
极限1311441-31144192.79294.641.5594.8996.751.54
2314895-31489593.82195.90
3315751-31575194.07796.17
4325589-32558997.00899.17
5320264-32026495.42197.51
6317933-31793394.72796.84
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%
19.923033333037833019783039633038433033800.28
29.943043273033093038180.24
单位质量响应值RSD%判断
30582.6630565.190.05数据可信
加速6月-供试品溶液-2024051721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%
5min1298146-29814688.80891.115.7288.8191.115.72
2317976-31797694.71594.71
3283517-28351784.45184.45
4290192-29019286.43986.44
5324674-32467496.71096.71
6320759-32075995.54495.54
10min1316433-31643394.25597.323.4994.7597.823.49
2327991-32799197.69898.22
3321200-32120095.67596.14
4322097-32209795.94296.42
5348658-348658103.854104.39
6323939-32393996.49197.02
15min1330608-33060898.47896.782.4999.4997.822.49
2322164-32216495.96297.03
3312514-31251493.08894.09
4323118-32311896.24797.26
5336234-336234100.153101.27
6324788-32478896.74497.81
20min1325945-32594597.08997.202.9598.6598.782.95
2322076-32207695.93697.54
3316146-31614694.17095.69
4318131-31813194.76196.31
5340122-340122101.311102.98
6335441-33544199.917101.52
极限1320344-32034495.42096.201.8997.5298.321.91
2325212-32521296.87099.01
3316297-31629794.21596.26
4322248-32224895.98798.06
5333838-33383899.440101.67
6319765-31976595.24897.41
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%
19.923037603040423047113035223034363038940.17
29.943051943052193052060.01
单位质量响应值RSD%判断
30634.4830704.830.17数据可信
长期6月-供试品溶液-2024051421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%
5min1296389-29638988.00992.765.1488.0192.765.14
2321294-32129495.40595.40
3319414-31941494.84694.85
4321369-32136995.42795.43
5327688-32768897.30397.30
6288120-28812085.55485.55
10min1323413-32341396.03498.532.8496.5299.042.85
2339140-339140100.704101.23
3335293-33529399.561100.09
4335083-33508399.499100.03
5340785-340785101.192101.73
6317110-31711094.16294.64
15min1322796-32279695.85198.833.1196.8799.893.11
2335830-33583099.721100.81
3333786-33378699.114100.19
4334031-33403199.187100.27
5349532-349532103.790104.89
6320913-32091395.29296.29
20min1319221-31922194.78997.682.4196.3499.292.43
2331617-33161798.470100.11
3329347-32934797.79699.43
4332817-33281798.826100.46
5340157-340157101.006102.69
6320624-32062495.20696.73
极限1320041-32004195.03396.901.1597.1199.061.19
2327220-32722097.16499.35
3329732-32973297.910100.08
4328873-32887397.65599.84
5328487-32848797.54199.78
6323668-32366896.11098.17
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%
19.923041633036513036893034653045443039020.15
29.943055903058343057120.06
单位质量响应值RSD%判断
30635.2830755.730.28数据可信
长期6月-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%
5min1279972-27997283.06591.616.3783.0691.616.37
2313287-31328792.94992.95
3335317-33531799.48599.48
4297080-29708088.14088.14
5303605-30360590.07690.08
6323326-32332695.92795.93
10min1309321-30932191.77298.004.1192.2398.514.12
2330978-33097898.19898.71
3348082-348082103.272103.82
4320941-32094195.22095.71
5335221-33522199.45799.96
6337415-337415100.107100.64
15min1310601-31060192.15298.023.5793.1299.083.58
2335208-33520899.453100.51
3340463-340463101.012102.14
4323536-32353695.99097.01
5330764-33076498.13499.19
6341783-341783101.403102.49
20min1307743-30774391.30496.203.4392.7997.793.44
2324038-32403896.13997.75
3341964-341964101.457103.14
4321880-32188095.49897.05
5321492-32149295.38396.98
6328277-32827797.39699.05
极限1312938-31293892.84597.503.3794.8499.633.39
2323783-32378396.06398.21
3344056-344056102.078104.33
4323501-32350195.97998.06
5330160-33016097.955100.08
6337331-337331100.083102.28
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%
19.923037403042553036553029733040303037310.16
29.943083663086253084960.06
单位质量响应值RSD%判断
30618.0431035.810.96数据可信
长期6月-供试品溶液-2024051721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%
5min1302587-30258789.39595.254.2189.4095.254.21
2330811-33081197.73497.73
3320175-32017594.59294.59
4316217-31621793.42293.42
5342752-342752101.262101.26
6321887-32188795.09795.10
10min1320806-32080694.77899.663.0195.27100.193.02
2337733-33773399.779100.32
3337341-33734199.663100.19
4334807-33480798.91499.43
5352134-352134104.033104.60
6341267-341267100.823101.35
15min1320950-32095094.82099.803.2195.84100.883.21
2338002-33800299.858100.96
3339718-339718100.365101.44
4331274-33127497.87198.94
5352384-352384104.107105.25
6344412-344412101.752102.84
20min1320895-32089594.80498.933.1196.35100.563.11
2338139-33813999.899101.55
3329073-32907397.22098.86
4330325-33032597.59099.20
5350813-350813103.643105.36
6339897-339897100.418102.07
极限1318601-31860194.12798.292.8596.20100.472.85
2328944-32894497.18299.39
3334656-33465698.870101.05
4329673-32967397.39899.55
5346807-346807102.460104.75
6337393-33739399.678101.89
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