奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.354598144592434588284587014582974589770.13
213.534575094576824575960.03
单位质量响应值RSD%判断
34380.3033820.841.17数据可信
供试品溶液-24052701-1批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169714-6971415.39514.834.1715.4014.834.17
269410-6941015.32815.33
363605-6360514.04614.05
465423-6542314.44814.45
569781-6978115.41015.41
664928-6492814.33814.34
10min1224974-22497449.68249.681.7149.8549.851.72
2226043-22604349.91850.09
3221184-22118448.84549.00
4226152-22615249.94250.10
5231056-23105651.02551.20
6220496-22049648.69348.85
15min1319066-31906670.46070.680.9971.1871.400.99
2317682-31768270.15470.88
3316328-31632869.85570.55
4325057-32505771.78372.50
5322215-32221571.15571.89
6320064-32006470.68071.38
20min1364948-36494880.59281.742.1282.1083.252.10
2371922-37192282.13283.64
3366976-36697681.04082.52
4379988-37998883.91485.43
5377623-37762383.39184.92
6359483-35948379.38580.87
30min1412138-41213891.01391.311.5393.4193.721.53
2414204-41420491.47093.89
3409204-40920490.36592.74
4422054-42205493.20395.65
5418601-41860192.44194.90
6404625-40462589.35491.72
45min1432756-43275695.56695.511.3198.9898.941.29
2432479-43247995.50598.94
3437976-43797696.719100.10
4436596-43659696.41499.90
5433322-43332295.69199.17
6421939-42193993.17896.54
60min1430712-43071295.11595.331.1199.5999.821.11
2427199-42719994.33998.83
3434902-43490296.040100.49
4435129-43512996.091100.64
5437069-43706996.519101.06
6425202-42520293.89898.29
极限1436796-43679696.45995.442.11101.99100.992.04
2433638-43363895.761101.30
3435828-43582896.245101.77
4429902-42990294.936100.56
5441618-44161897.524103.14
6415343-41534391.72197.16
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数200
标示量(mg)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.354689374690154686914689124678944686900.10
213.534684554691384687960.11
单位质量响应值RSD%判断
35107.8734648.630.94数据可信
供试品溶液-24052702-1批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108284-10828423.37922.687.4723.3822.687.48
2107145-10714523.13323.13
3112022-11202224.18624.19
4111485-11148524.07024.07
592133-9213319.89219.89
699080-9908021.39221.39
10min1273584-27358459.06857.902.6259.3358.162.61
2262079-26207956.58456.84
3279688-27968860.38660.65
4263276-26327656.84257.11
5266839-26683957.61157.83
6263682-26368256.93057.17
15min1357048-35704877.08876.091.7778.0076.981.76
2349131-34913175.37976.26
3357049-35704977.08878.03
4349058-34905875.36376.26
5358983-35898377.50678.37
6343232-34323274.10574.98
20min1403178-40317887.04785.351.9888.8287.091.95
2383365-38336582.77084.49
3396573-39657385.62187.42
4392580-39258084.75986.50
5404178-40417887.26388.99
6391971-39197184.62886.32
30min1440551-44055195.11692.792.8597.8695.482.81
2411775-41177588.90491.55
3443083-44308395.66398.41
4421035-42103590.90393.58
5436082-43608294.15296.84
6426125-42612592.00294.64
45min1444937-44493796.06394.761.7399.8698.481.74
2428938-42893892.60996.24
3444906-44490696.05799.87
4439693-43969394.93198.62
5445007-44500796.07899.82
6430035-43003592.84696.50
60min1449782-44978297.10995.711.14101.97100.481.16
2440618-44061895.13199.79
3447269-44726996.567101.44
4436782-43678294.30399.05
5445663-44566396.220101.03
6439585-43958594.90899.60
极限1448741-44874196.88594.911.20102.83100.751.15
2442874-44287495.618101.33
3435087-43508793.93799.89
4437699-43769994.501100.29
5437333-43733394.422100.30
6435923-43592394.11799.86
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