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%
113.592711652711522712452712462711732711960.02
213.672729002724422726710.12
单位质量响应值RSD%判断
19955.5619946.670.04数据可信
供试品溶液-B24060751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%
5min1319026-31902691.01593.284.0491.0293.284.04
2336545-33654596.01396.01
3320285-32028591.37491.37
4329542-32954294.01594.02
5309987-30998788.43788.44
6346355-34635598.81298.81
10min1330681-33068194.34096.411.6694.8596.931.66
2338081-33808196.45196.98
3344201-34420198.19798.71
4342938-34293897.83798.36
5331891-33189194.68695.18
6339791-33979196.93997.49
15min1329468-32946893.99496.362.0195.0297.422.00
2335146-33514695.61496.68
3342971-34297197.84798.90
4347916-34791699.257100.32
5332920-33292094.97996.00
6338244-33824496.49897.59
20min1329045-32904593.87496.571.8395.4398.161.83
2335508-33550895.71797.32
3343440-34344097.98099.58
4344693-34469398.33899.96
5335360-33536095.67597.22
6342887-34288797.82399.45
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%
113.592714192711002713052712892715182713260.06
213.672723182721762722470.04
单位质量响应值RSD%判断
19965.1219915.650.18数据可信
供试品溶液-B24060751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%
5min1322405-32240592.02992.011.7992.0392.011.79
2323372-32337292.30592.30
3318352-31835290.87290.87
4324662-32466292.67392.67
5331108-33110894.51394.51
6314176-31417689.68089.68
10min1334597-33459795.50995.441.6396.0295.961.62
2334961-33496195.61396.13
3333823-33382395.28895.79
4324453-32445392.61393.13
5340257-34025797.12597.65
6338142-33814296.52197.02
15min1334521-33452195.48795.052.3896.5396.102.37
2334788-33478895.56496.61
3327638-32763893.52394.56
4320575-32057591.50692.54
5343440-34344098.03399.10
6337001-33700196.19597.23
20min1335180-33518095.67595.291.8597.2596.861.84
2334685-33468595.53497.11
3331180-33118094.53496.09
4323043-32304392.21193.75
5340090-34009097.07798.69
6338803-33880396.71098.28
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%
113.592715462723002720132720952714692718850.14
213.672701082696172698620.13
单位质量响应值RSD%判断
20006.2519741.190.95数据可信
供试品溶液-B24060951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%
5min1340049-34004997.39595.553.2997.4095.553.29
2343319-34331998.33298.33
3338428-33842896.93196.93
4320525-32052591.80391.80
5340612-34061297.55697.56
6318749-31874991.29491.29
10min1362790-362790103.908101.391.63104.45101.921.63
2352888-352888101.072101.62
3352087-352087100.843101.38
4355957-355957101.951102.46
5355132-355132101.715102.26
6345202-34520298.87199.38
15min1359888-359888103.077101.001.88104.20102.091.87
2352426-352426100.940102.05
3346107-34610799.130100.23
4355142-355142101.718102.79
5358580-358580102.703103.81
6343626-34362698.42099.48
20min1331695-33169595.00299.432.7296.69101.082.68
2352023-352023100.825102.49
3348793-34879399.899101.55
4353065-353065101.123102.76
5357060-357060102.267103.94
6340350-34035097.48199.08
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%
113.592725982726952727492724862725932726240.04
213.672721482720332720900.03
单位质量响应值RSD%判断
20060.6319904.170.56数据可信
供试品溶液-B24060951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%
5min1335398-33539895.53895.331.9895.5495.331.98
2343363-34336397.80697.81
3324922-32492292.55492.55
4331807-33180794.51594.51
5332104-33210494.59994.60
6340382-34038296.95796.96
10min1359501-359501102.403101.581.86102.93102.111.86
2368620-368620105.001105.54
3350342-35034299.794100.31
4354984-354984101.117101.64
5353378-353378100.659101.18
6352943-352943100.535101.07
15min1358876-358876102.225100.271.41103.33101.371.41
2355810-355810101.352102.48
3345054-34505498.28899.36
4349975-34997599.690100.78
5352976-352976100.545101.63
6349395-34939599.525100.62
20min1341481-34148197.27098.912.4798.94100.572.44
2352641-352641100.449102.14
3343504-34350497.84799.46
4336301-33630195.79597.44
5360113-360113102.578104.22
6349476-34947699.548101.20
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%
113.592717092721192720022719352717602719050.07
213.672724672722992723830.05
单位质量响应值RSD%判断
20007.7319925.600.30数据可信
供试品溶液-B24061151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%
5min1320664-32066491.41296.445.0991.4196.445.09
2335815-33581595.73195.73
3338357-33835796.45596.46
4319026-31902690.94590.94
5360573-360573102.789102.79
6355464-355464101.332101.33
10min1324165-32416592.41099.643.9592.92100.173.95
2354516-354516101.062101.59
3346593-34659398.80399.34
4349384-34938499.599100.10
5361021-361021102.916103.49
6361400-361400103.024103.59
15min1327464-32746493.35099.633.8894.37100.723.88
2342516-34251697.64198.73
3349535-34953599.642100.73
4350872-350872100.023101.08
5363759-363759103.697104.84
6362847-362847103.437104.57
20min1330896-33089694.32999.713.6995.87101.353.69
2340441-34044197.05098.69
3349122-34912299.524101.16
4351000-351000100.060101.67
5364692-364692103.963105.68
6362468-362468103.329105.04
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%
113.592707492711662709422708972707652709040.07
213.672733792735522734660.05
单位质量响应值RSD%判断
19934.0720004.830.26数据可信
供试品溶液-B24061151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%
5min1319237-31923790.99295.692.8790.9995.692.87
2345536-34553698.48898.49
3336471-33647195.90495.90
4340037-34003796.92196.92
5330370-33037094.16594.17
6342645-34264597.66497.66
10min1342284-34228497.56198.991.3598.0799.521.35
2352763-352763100.548101.10
3350116-35011699.794100.33
4342056-34205697.49698.03
5345371-34537198.44198.96
6351155-351155100.090100.63
15min1336175-33617595.820100.323.4196.87101.403.38
2349366-34936699.580100.69
3357020-357020101.761102.85
4349196-34919699.531100.61
5347790-34779099.131100.20
6372225-372225106.095107.19
20min1336296-33629695.85499.772.2397.43101.422.22
2353599-353599100.786102.45
3358939-358939102.308103.96
4352538-352538100.484102.12
5346692-34669298.818100.44
6352237-352237100.398102.09
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