奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.374536764517534478874537844529144520030.54
213.394429084450174439620.34
单位质量响应值RSD%判断
33807.2633156.241.38数据可信
供试品溶液-2024081821-1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%
5min128850-288506.4316.159.826.436.149.80
224942-249425.5605.56
326336-263365.8705.87
430901-309016.8886.89
529941-299416.6746.67
624439-244395.4485.45
10min1118799-11879926.48125.762.9626.4925.772.95
2114194-11419425.45425.46
3110942-11094224.72924.74
4113885-11388525.38525.40
5120203-12020326.79426.80
6115379-11537925.71825.73
15min1211110-21111047.05744.803.1147.1144.853.11
2200246-20024644.63644.69
3196003-19600343.69043.74
4193122-19312243.04843.10
5202626-20262645.16645.22
6202678-20267845.17845.23
20min1278843-27884362.15559.163.1762.2959.293.17
2265207-26520759.11659.24
3259993-25999357.95358.08
4253994-25399456.61656.74
5265509-26550959.18359.31
6268932-26893259.94660.07
30min1361477-36147780.57577.362.6180.8177.582.61
2347739-34773977.51277.74
3342030-34203076.24076.46
4334447-33444774.54974.77
5345681-34568177.05477.28
6350856-35085678.20778.43
45min1421149-42114993.87690.632.1894.2590.992.19
2407298-40729890.78891.14
3402939-40293989.81790.16
4394218-39421887.87388.22
5404430-40443090.14990.51
6409592-40959291.30091.66
60min1445413-44541399.28496.432.0299.8196.942.02
2433160-43316096.55397.06
3428028-42802895.40995.91
4420072-42007293.63694.13
5430622-43062295.98796.50
6438478-43847897.73898.25
极限1456457-456457101.74699.461.73102.44100.131.73
2446447-44644799.515100.18
3441344-44134498.37799.03
4434964-43496496.95597.60
5445497-44549799.30399.97
6452516-452516100.867101.54
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.374442514466124449104464744449334454360.24
213.394425024451554438280.43
单位质量响应值RSD%判断
33316.0833146.230.37数据可信
供试品溶液-2024081821-3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%
5min1-0.00011.0078.900.0011.0178.90
280733-8073318.13018.13
371687-7168716.09816.10
480802-8080218.14518.15
5-0.0000.00
660814-6081413.65713.66
10min148469-4846910.88432.0441.4110.8832.0641.43
2187975-18797542.21342.24
3180059-18005940.43540.46
4188691-18869142.37342.40
590709-9070920.37020.37
6160252-16025235.98736.01
15min1169108-16910837.97651.0416.5137.9951.1116.56
2258953-25895358.15258.25
3254100-25410057.06257.16
4258244-25824457.99358.09
5196134-19613444.04544.08
6227204-22720451.02251.10
20min1257755-25775557.88364.047.8057.9664.197.86
2307620-30762069.08169.28
3304367-30436768.35068.54
4302678-30267867.97168.17
5265208-26520859.55659.66
6273342-27334261.38361.55
30min1348605-34860578.28479.043.6678.4679.303.69
2365540-36554082.08782.40
3364174-36417481.78182.08
4357948-35794880.38380.69
5342239-34223976.85577.06
6333242-33324274.83475.10
45min1407169-40716991.43690.012.3191.7490.412.30
2408736-40873691.78892.24
3407850-40785091.58992.03
4399202-39920289.64790.09
5397302-39730289.22089.55
6384772-38477286.40686.80
60min1432856-43285697.20495.391.8897.6795.941.86
2430116-43011696.58997.19
3429185-42918596.38096.97
4420550-42055094.44195.03
5424884-42488495.41495.90
6411135-41113592.32692.87
极限1449445-449445100.93099.411.33101.55100.121.29
2444707-44470799.866100.63
3446215-446215100.204100.96
4435638-43563897.82998.58
5444766-44476699.879100.52
6435303-43530397.75498.45
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5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%
113.374449404449424454784449934449924450690.06
213.394437704456434447060.30
单位质量响应值RSD%判断
33288.6333211.800.17数据可信
供试品溶液-2024081821-5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%
5min131579-315797.0876.765.987.096.765.97
230496-304966.8446.84
327875-278756.2566.26
428072-280726.3006.30
530418-304186.8276.83
632264-322647.2417.24
10min1107089-10708924.03523.563.7824.0523.573.78
2104396-10439623.43023.44
398568-9856822.12222.13
4103958-10395823.33223.34
5110580-11058024.81824.83
6105205-10520523.61223.62
15min1184212-18421241.34440.633.4941.4040.683.48
2180543-18054340.52040.57
3170112-17011238.17938.23
4183361-18336141.15341.20
5188758-18875842.36442.42
6179094-17909440.19540.25
20min1242755-24275554.48354.022.6354.6054.142.63
2239093-23909353.66153.78
3230445-23044551.72051.83
4245479-24547955.09455.21
5248345-24834555.73755.86
6238138-23813853.44653.56
30min1319603-31960371.73071.631.7271.9471.831.72
2316950-31695071.13571.34
3310710-31071069.73469.93
4325901-32590173.14473.35
5324223-32422372.76772.98
6317456-31745671.24871.46
45min1380617-38061785.42485.631.4185.7585.951.41
2378320-37832084.90885.23
3375351-37535184.24284.56
4389647-38964787.45087.78
5386161-38616186.66887.01
6379031-37903185.06885.39
60min1411639-41163992.38692.771.3192.8693.241.31
2409213-40921391.84292.31
3407660-40766091.49391.95
4421247-42124794.54395.02
5418639-41863993.95794.44
6411701-41170192.40092.87
极限1433597-43359797.31497.991.3797.9498.621.37
2433698-43369897.33797.96
3431076-43107696.74997.35
4445437-44543799.972100.61
5442801-44280199.380100.02
6433034-43303497.18897.81
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