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%
113.524600294597004594094596454594944596550.06
213.504603564594444599000.15
单位质量响应值RSD%判断
33998.1534066.670.15数据可信
长期6月-供试品溶液-2024102421批-pH2.0(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%
5min1-0.0002.4678.230.002.4678.25
215885-158853.4833.48
315386-153863.3743.37
4-0.0000.00
518951-189514.1564.16
616984-169843.7243.72
10min150510-5051011.07612.3212.2411.0812.3512.33
251342-5134211.25811.30
363405-6340513.90313.94
448871-4887110.71610.72
564533-6453314.15114.20
658478-5847812.82312.86
15min1101408-10140822.23618.8614.3322.3619.0214.20
296486-9648621.15721.32
384797-8479718.59418.79
469045-6904515.14015.26
588878-8887819.48919.69
675329-7532916.51816.70
20min1122829-12282926.93424.787.6727.3025.167.68
2116269-11626925.49525.89
3114722-11472225.15625.55
4101019-10101922.15122.44
5119317-11931726.16326.58
6103988-10398822.80223.17
30min1175011-17501138.37635.746.8539.0536.396.85
2168107-16810736.86237.54
3169920-16992037.25937.94
4152202-15220233.37433.91
5166262-16626236.45737.17
6146386-14638632.09932.72
45min1239188-23918852.44849.953.8053.5451.003.86
2231191-23119150.69551.79
3228556-22855650.11751.21
4220002-22000248.24149.15
5232360-23236050.95152.07
6215522-21552247.25948.24
60min1289389-28938963.45660.213.6765.1361.813.71
2279329-27932961.25062.91
3275947-27594760.50962.16
4266092-26609258.34859.79
5275907-27590760.50062.18
6260843-26084357.19758.70
极限1318669-31866969.87767.272.7972.2669.542.85
2315380-31538069.15571.49
3305740-30574067.04269.36
4299013-29901365.56767.66
5304325-30432566.73169.09
6297686-29768665.27667.41
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%
113.524596914600304602104604304602464601210.07
213.504588854587454588150.03
单位质量响应值RSD%判断
34032.6233986.300.10数据可信
长期6月-供试品溶液-2024102521批-pH2.0(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%
5min115997-159973.5103.0379.523.513.0379.51
222101-221014.8494.85
323116-231165.0725.07
4-0.0000.00
5-0.0000.00
621557-215574.7304.73
10min150178-5017811.01010.659.4111.0510.699.54
255549-5554912.18912.24
348443-4844310.63010.69
441413-414139.0879.09
547277-4727710.37410.37
648432-4843210.62710.68
15min177387-7738716.98116.647.0217.1416.797.12
282691-8269118.14418.33
372681-7268115.94816.12
468066-6806614.93515.04
574054-7405416.24916.36
680166-8016617.59017.76
20min1104588-10458822.94922.286.5023.3022.626.60
2107622-10762223.61524.01
399179-9917921.76222.11
491127-9112719.99520.26
598357-9835721.58221.88
6108407-10840723.78724.15
30min1150935-15093533.11932.643.7533.7233.223.84
2157165-15716534.48635.14
3144512-14451231.70932.30
4141127-14112730.96731.46
5148197-14819732.51833.05
6150544-15054433.03333.66
45min1214843-21484347.14246.052.4848.1146.992.53
2215998-21599847.39548.43
3201885-20188544.29845.24
4207391-20739145.50746.34
5208291-20829145.70446.60
6210680-21068046.22847.23
60min1259707-25970756.98655.872.1458.4857.322.20
2258485-25848556.71858.28
3247426-24742654.29155.73
4249727-24972754.79656.13
5252487-25248755.40256.81
6259803-25980357.00758.52
极限1290070-29007063.64863.661.1765.7865.741.18
2294319-29431964.58166.77
3284283-28428362.37964.42
4290435-29043563.72965.68
5292251-29225164.12766.15
6289491-28949163.52165.67
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%
113.524600074595784595344588384587514593420.12
213.504579074593794586430.23
单位质量响应值RSD%判断
33975.0033973.560.01数据可信
长期6月-供试品溶液-2024102621批-pH2.0(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%
5min111966-119662.6281.21163.482.631.21163.44
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
621042-210424.6224.62
10min143993-439939.6639.738.149.699.748.02
246123-4612310.13110.13
339935-399358.7728.77
449205-4920510.80810.81
546027-4602710.11010.11
640384-403848.8708.92
15min172922-7292216.01715.967.2816.1516.087.19
273505-7350516.14516.26
369054-6905415.16815.27
481877-8187717.98418.10
572198-7219815.85815.97
666284-6628414.55914.71
20min1103681-10368122.77422.046.7223.0922.346.66
2100477-10047722.07022.36
395198-9519820.91021.18
4110241-11024124.21524.53
5101601-10160122.31722.61
690880-9088019.96220.27
30min1147444-14744432.38631.814.9732.9532.354.96
2147741-14774132.45232.99
3137836-13783630.27630.77
4154210-15421033.87234.46
5146879-14687932.26232.80
6134745-13474529.59730.13
45min1198931-19893143.69543.693.5044.6244.593.52
2196690-19669043.20344.10
3193047-19304742.40343.24
4211847-21184746.53347.50
5199901-19990143.90944.80
6193137-19313742.42343.29
60min1240884-24088452.91154.243.1954.3255.623.19
2242160-24216053.19154.57
3247067-24706754.26955.57
4261775-26177557.49958.98
5248055-24805554.48655.87
6241548-24154853.05654.39
极限1275990-27599060.62260.672.2662.6262.662.25
2277853-27785361.03163.00
3281119-28111961.74863.66
4282551-28255162.06364.18
5274856-27485660.37362.36
6264995-26499558.20760.13
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