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%
113.694643884647404647564639874639174643580.09
213.704619034624264621640.09
单位质量响应值RSD%判断
33919.5033734.600.39数据可信
长期3月-供试品溶液-6000597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%
5min183687-8368718.46214.6133.8018.4614.6133.81
286947-8694719.18119.18
362971-6297113.89213.89
481726-8172618.03018.03
529883-298836.5926.59
652142-5214211.50311.50
10min1193251-19325142.63337.9810.3742.6638.0010.38
2190738-19073842.07942.11
3155526-15552634.31034.33
4179629-17962939.62839.66
5158197-15819734.90034.91
6155565-15556534.31934.34
15min1249996-24999655.15154.384.4155.2554.464.42
2256060-25606056.48956.59
3235603-23560351.97652.06
4258117-25811756.94357.04
5247883-24788354.68554.75
6231285-23128551.02451.10
20min1297113-29711365.54665.653.1565.7465.833.16
2301525-30152566.51966.72
3292577-29257764.54564.71
4310822-31082268.57068.76
5300577-30057766.31066.47
6282970-28297062.42662.59
30min1351233-35123377.48578.943.0377.7979.223.02
2354780-35478078.26878.57
3358863-35886379.16879.44
4375274-37527482.78983.09
5363103-36310380.10480.37
6343695-34369575.82276.09
45min1396235-39623587.41389.172.8287.8589.592.82
2395315-39531587.21087.65
3409010-40901090.23190.64
4421226-42122692.92693.37
5411225-41122590.72091.12
6392164-39216486.51586.91
60min1421995-42199593.09694.372.7293.6794.932.71
2415951-41595191.76392.35
3433619-43361995.66096.22
4444609-44460998.08598.68
5434325-43432595.81696.37
6416009-41600991.77592.31
极限1451896-45189699.69299.562.40100.43100.282.39
2433680-43368095.67496.41
3456588-456588100.727101.44
4465009-465009102.585103.35
5455437-455437100.474101.19
6445135-44513598.20198.89
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%
113.694643504643664646444635024636204640960.11
213.704667214660104663660.11
单位质量响应值RSD%判断
33900.3734041.310.30数据可信
长期3月-供试品溶液-6000597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%
5min155926-5592612.28611.4228.4212.2911.4228.43
229589-295896.5006.50
367214-6721414.76514.77
438162-381628.3838.38
559008-5900812.96312.96
662079-6207913.63713.64
10min1164730-16473036.18736.583.6236.2136.603.62
2164263-16426336.08436.10
3175288-17528838.50638.53
4161551-16155135.48935.50
5160708-16070835.30335.33
6172660-17266037.92937.95
15min1237426-23742652.15653.073.8352.2453.153.82
2251769-25176955.30755.38
3249322-24932254.77054.86
4237365-23736552.14352.22
5227244-22724449.92050.00
6246270-24627054.09954.19
20min1281709-28170961.88463.703.5562.0563.873.54
2303385-30338566.64666.81
3295159-29515964.83965.02
4287803-28780363.22363.38
5275535-27553560.52860.69
6296242-29624265.07765.25
30min1338761-33876174.41776.782.8874.6977.062.87
2362913-36291379.72380.00
3353204-35320477.59077.88
4349481-34948176.77277.04
5337065-33706574.04574.31
6355802-35580278.16178.45
45min1384581-38458184.48387.272.6384.8887.682.63
2408037-40803789.63590.04
3406382-40638289.27289.69
4398934-39893487.63688.03
5384450-38445084.45484.84
6401355-40135588.16888.58
60min1409340-40934089.92292.882.5990.4693.432.59
2432315-43231594.96995.53
3434964-43496495.55196.12
4424970-42497093.35593.89
5409874-40987490.03990.57
6425335-42533593.43594.00
极限1436902-43690295.97698.032.3296.6698.742.32
2450065-45006598.86899.58
3460309-460309101.118101.84
4447778-44777898.36599.06
5431762-43176294.84795.53
6450754-45075499.01999.74
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