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%
113.474625484633014635704626514633534630850.10
213.494619264632084625670.20
单位质量响应值RSD%判断
34378.9934289.620.19数据可信
供试品溶液-2024102121批-pH4.5(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%
5min130707-307076.6745.9615.206.675.9615.16
233834-338347.3547.35
325226-252265.4835.48
422725-227254.9394.94
527413-274135.9585.96
624597-245975.3465.35
10min193800-9380020.38719.0310.3420.4019.0410.34
2102062-10206222.18322.20
385288-8528818.53718.55
477705-7770516.88916.90
586378-8637818.77418.78
680066-8006617.40217.41
15min1154201-15420133.51532.177.7433.5632.217.74
2166957-16695736.28836.34
3147857-14785732.13732.18
4136481-13648129.66429.70
5145422-14542231.60731.65
6137156-13715629.81129.85
20min1207277-20727745.05144.036.2045.1544.126.20
2223598-22359848.59948.71
3204590-20459044.46744.56
4190853-19085341.48241.57
5199641-19964143.39243.49
6189448-18944841.17641.26
30min1288408-28840862.68562.514.4262.8662.674.43
2308908-30890867.14167.33
3292494-29249463.57363.74
4277193-27719360.24860.40
5285569-28556962.06862.23
6272925-27292559.32059.48
45min1365134-36513479.36180.153.2879.6480.423.29
2387689-38768984.26484.57
3376171-37617181.76082.03
4359194-35919478.07078.33
5370074-37007480.43580.70
6354274-35427477.00177.26
60min1408025-40802588.68489.842.7589.1090.242.76
2430037-43003793.46893.91
3420797-42079791.46091.87
4404534-40453487.92588.31
5417063-41706390.64891.05
6399588-39958886.85087.23
极限1434222-43422294.37895.432.3694.9495.992.37
2453182-45318298.49899.10
3446561-44656197.05997.62
4430451-43045193.55894.09
5443627-44362796.42296.98
6426450-42645092.68893.22
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%
113.474653284626864623564628154632294632830.26
213.494717884731044724460.20
单位质量响应值RSD%判断
34393.6935021.941.28数据可信
供试品溶液-2024102121批-pH4.5(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%
5min126186-261865.6314.8313.135.634.8313.11
223367-233675.0255.02
321517-215174.6274.63
417294-172943.7193.72
523253-232535.0005.00
623239-232394.9975.00
10min186331-8633118.56317.296.7618.5717.306.76
284891-8489118.25418.26
382318-8231817.70117.71
471412-7141215.35515.36
579955-7995517.19217.20
677685-7768516.70416.71
15min1147754-14775431.77130.285.0131.8130.325.01
2147862-14786231.79431.83
3143912-14391230.94530.98
4129927-12992727.93827.97
5139249-13924929.94229.98
6136341-13634129.31729.35
20min1204973-20497344.07542.433.8444.1742.523.85
2206228-20622844.34544.44
3199152-19915242.82342.91
4187010-18701040.21240.29
5195332-19533242.00242.09
6191368-19136841.14941.23
30min1291475-29147562.67561.652.1462.8461.812.15
2295411-29541163.52163.69
3287158-28715861.74761.91
4278055-27805559.78959.93
5284681-28468161.21461.37
6283533-28353360.96761.12
45min1374691-37469180.56980.121.4680.8480.381.47
2379111-37911181.51981.79
3366952-36695278.90579.17
4366366-36636678.77979.02
5377751-37775181.22781.49
6370718-37071879.71479.97
60min1421309-42130990.59391.001.1391.0091.391.13
2426179-42617991.64092.05
3417892-41789289.85890.25
4418029-41802989.88790.26
5428926-42892692.23192.62
6426850-42685091.78492.17
极限1450619-45061996.89597.791.2997.4598.331.28
2456768-45676898.21798.78
3450127-45012796.78997.33
4450781-45078196.93097.46
5465292-465292100.050100.60
6455026-45502697.84398.38
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