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800
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%
114.072683522678742686102683532685012683380.11
214.062686942685682686310.04
单位质量响应值RSD%判断
19071.6419106.050.13数据可信
供试品溶液-2023071521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%
5min1296874-29687488.52193.186.9188.5293.186.90
2283210-28321084.44784.45
3304042-30404290.65990.66
4325422-32542297.03497.03
5341821-341821101.924101.92
6323674-32367496.51396.51
10min1330286-33028698.484100.712.8998.98101.232.91
2323409-32340996.43496.90
3336171-336171100.239100.74
4344824-344824102.819103.36
5349665-349665104.262104.83
6342229-342229102.045102.58
15min1328434-32843497.932101.052.3998.97102.122.41
2330337-33033798.49999.50
3339640-339640101.273102.33
4343147-343147102.319103.43
5349551-349551104.228105.37
6342167-342167102.027103.13
20min1334675-33467599.793100.841.37101.38102.481.41
2332018-33201899.001100.55
3336240-336240100.259101.88
4340599-340599101.559103.24
5344219-344219102.639104.36
6341467-341467101.818103.49
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800
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%
114.072686892688022687252684742683852686150.07
214.062687462684902686180.07
单位质量响应值RSD%判断
19091.3319105.120.06数据可信
供试品溶液-2023071521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%
5min1309116-30911692.12693.562.2292.1393.562.22
2322991-32299196.26296.26
3312041-31204192.99893.00
4309040-30904092.10492.10
5307850-30785091.74991.75
6322455-32245596.10296.10
10min1335444-33544499.973100.340.98100.48100.860.97
2331585-33158598.82399.36
3339718-339718101.247101.76
4335841-335841100.091100.60
5336757-336757100.364100.87
6340732-340732101.549102.08
15min1333527-33352799.402100.601.03100.47101.681.03
2337246-337246100.510101.59
3340164-340164101.380102.46
4335504-33550499.991101.06
5335923-335923100.116101.18
6343003-343003102.226103.32
20min1337645-337645100.629100.540.44102.25102.180.45
2338448-338448100.868102.51
3338128-338128100.773102.42
4336618-336618100.323101.95
5334718-33471899.757101.38
6338572-338572100.905102.57
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800
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%
114.072730482733022730402728082728952730190.07
214.062690422689322689870.03
单位质量响应值RSD%判断
19404.3419131.371.01数据可信
供试品溶液-2023071821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%
5min1319735-31973594.45795.011.3494.4695.021.34
2324068-32406895.73795.74
3318369-31836994.05394.05
4328910-32891097.16797.17
5321339-32133994.93194.93
6317307-31730793.74093.74
10min1332098-33209898.109100.221.5898.63100.741.58
2334910-33491098.94099.47
3345956-345956102.203102.73
4344357-344357101.731102.27
5340023-340023100.450100.98
6338071-33807199.874100.39
15min1335776-33577699.196100.591.02100.27101.681.01
2338291-33829199.939101.02
3345278-345278102.003103.09
4343478-343478101.471102.58
5340131-340131100.482101.57
6339999-339999100.443101.52
20min1326927-32692796.58299.392.7598.20101.032.72
2327103-32710396.63498.27
3345851-345851102.172103.83
4347977-347977102.800104.47
5338856-338856100.106101.75
6331856-33185698.03899.67
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800
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%
114.072685772685272687102686282684972685880.04
214.062691632686972689300.13
单位质量响应值RSD%判断
19089.4119127.310.15数据可信
供试品溶液-2023071821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%
5min1324420-32442096.63695.821.0096.6495.821.00
2325499-32549996.95896.96
3317354-31735494.53194.53
4318871-31887194.98394.98
5322894-32289496.18296.18
6320957-32095795.60595.60
10min1336109-336109100.118100.951.00100.65101.480.99
2337511-337511100.536101.07
3342185-342185101.928102.45
4334778-33477899.722100.25
5339615-339615101.162101.70
6343242-343242102.243102.77
15min1340368-340368101.387101.430.76102.48102.520.76
2339040-339040100.991102.09
3343795-343795102.407103.50
4336394-336394100.203101.28
5341286-341286101.660102.76
6342196-342196101.931103.03
20min1338637-338637100.871100.151.61102.53101.811.59
2331441-33144198.728100.39
3343571-343571102.341104.00
4329857-32985798.25699.89
5333652-33365299.386101.05
6340183-340183101.332103.00
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800
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%
114.072704742702462703862702332702502703180.04
214.062704422700152702280.12
单位质量响应值RSD%判断
19212.3719219.630.03数据可信
供试品溶液-2023072021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%
5min1278486-27848682.48988.745.6282.4988.745.62
2318687-31868794.39794.40
3285832-28583284.66584.66
4302036-30203689.46589.46
5293579-29357986.96086.96
6318885-31888594.45594.46
10min1317466-31746694.03595.871.7694.4996.361.77
2332222-33222298.40698.93
3323151-32315195.71996.19
4324664-32466496.16796.66
5317559-31755994.06394.55
6326909-32690996.83297.36
15min1319565-31956594.65796.001.1195.6497.031.13
2329622-32962297.63698.71
3321826-32182695.32696.33
4325983-32598396.55897.59
5322391-32239195.49496.50
6325263-32526396.34497.41
20min1323686-32368695.87796.250.9797.3897.810.98
2328258-32825897.23298.85
3328095-32809597.18398.72
4325342-32534296.36897.94
5319808-31980894.72996.26
6324469-32446996.10997.71
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800
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%
114.072704382705842704102702612697942702970.12
214.062704962702282703620.08
单位质量响应值RSD%判断
19210.8719229.160.07数据可信
供试品溶液-2023072021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%
5min1285137-28513784.44188.193.6984.4488.193.69
2309623-30962391.69391.69
3294464-29446487.20387.20
4294433-29443387.19487.19
5312830-31283092.64292.64
6290376-29037685.99385.99
10min1318284-31828494.25895.681.1394.7396.171.15
2325996-32599696.54197.05
3324472-32447296.09096.57
4322509-32250995.50995.99
5327617-32761797.02197.54
6319595-31959594.64695.12
15min1322698-32269895.56595.910.8796.5696.930.88
2325873-32587396.50597.55
3323164-32316495.70396.72
4322992-32299295.65296.67
5328218-32821897.19998.25
6320201-32020194.82595.83
20min1323717-32371795.86796.140.4497.3997.700.45
2324458-32445896.08697.67
3326437-32643796.67298.22
4323962-32396295.93997.49
5326316-32631696.63698.23
6322991-32299195.65297.18
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