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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.40对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.664520674520224505384511574520154515600.16
213.664506094507354506720.02
单位质量响应值RSD%判断
33057.1032992.090.14数据可信
供试品溶液-2024081821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%
5min1100217-10021722.85120.709.9422.8520.709.93
293010-9301021.20721.21
385907-8590719.58819.59
4100795-10079522.98222.98
577539-7753917.68017.68
687174-8717419.87719.88
10min1208367-20836747.51045.255.1147.7645.485.13
2204231-20423146.56746.80
3186134-18613442.44142.66
4207934-20793447.41147.67
5186662-18666242.56142.76
6197311-19731144.98945.21
15min1274119-27411962.50261.193.5563.2861.923.58
2272674-27267462.17362.93
3252468-25246857.56658.25
4276258-27625862.99063.77
5260877-26087759.48360.15
6273866-27386662.44563.17
20min1331963-33196375.69272.123.2777.1773.543.30
2318374-31837472.59374.04
3303582-30358269.22070.55
4320867-32086773.16274.64
5306227-30622769.82371.15
6316878-31687872.25273.67
30min1364089-36408983.01783.582.4985.3385.802.48
2370024-37002484.37086.62
3352798-35279880.44282.54
4369082-36908284.15586.45
5363145-36314582.80184.91
6380279-38027986.70888.93
45min1408623-40862393.17194.141.5996.4197.281.61
2416559-41655994.98098.17
3405497-40549792.45895.45
4423832-42383296.63999.87
5409924-40992493.46896.49
6412733-41273394.10897.29
60min1434432-43443299.05697.401.70103.33101.591.67
2418679-41867995.46499.71
3425535-42553597.027101.05
4426532-42653297.254101.56
5420963-42096395.985100.05
6436975-43697599.636103.86
极限1435888-43588899.388100.110.71104.76105.380.65
2443330-443330101.085106.39
3442223-442223100.832105.93
4438936-438936100.083105.47
5436624-43662499.556104.69
6437285-43728599.706105.04
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对照品来源中检所对照品使用方法直接使用
对照品含量(%)100.40对照品水分(%)0对照品稀释倍数200
标示量(mg)60供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.664523834500904513854516924509634513030.19
213.664553684561564557620.13
单位质量响应值RSD%判断
33038.2933364.710.70数据可信
供试品溶液-2024081821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%
5min172919-7291916.53819.1010.6316.5419.1010.63
295377-9537721.63221.63
394483-9448321.42921.43
483354-8335418.90518.90
579470-7947018.02418.02
679779-7977918.09418.09
10min1194648-19464844.14743.065.6944.3343.275.68
2206135-20613546.75246.99
3194640-19464044.14544.38
4176186-17618639.95940.17
5181690-18169041.20841.41
6185721-18572142.12242.32
15min1270373-27037361.32158.155.0262.0058.845.01
2267120-26712060.58361.34
3261832-26183259.38460.11
4235782-23578253.47654.13
5248695-24869556.40557.06
6254492-25449257.71958.39
20min1314270-31427071.27767.824.5072.6369.164.50
2309838-30983870.27271.70
3300808-30080868.22469.61
4276250-27625062.65463.90
5293265-29326566.51367.80
6299858-29985868.00969.32
30min1371429-37142984.24179.933.8486.3982.023.83
2356707-35670780.90283.12
3351240-35124079.66281.81
4329418-32941874.71376.66
5351897-35189779.81181.83
6353875-35387580.26082.33
45min1415549-41554994.24889.503.3297.3392.483.32
2396713-39671389.97593.09
3391415-39141588.77491.81
4374670-37467084.97687.75
5396541-39654189.93692.85
6392873-39287389.10592.06
60min1437808-43780899.29693.973.29103.4397.943.28
2413514-41351493.78697.90
3410409-41040993.08297.10
4395923-39592389.79693.52
5417393-41739394.66698.58
6410879-41087993.18897.14
极限1450789-450789102.24097.412.76107.47102.422.77
2431196-43119697.796102.95
3423051-42305195.949101.00
4415534-41553494.24498.96
5429185-42918597.340102.30
6427185-42718596.887101.87
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