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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数100
标示量(mg)120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%
113.439119709125069130439116269117319121750.07
213.409098749089429094080.08
单位质量响应值RSD%判断
67920.7067866.270.06数据可信
供试品溶液-24041501-1批-pH4.5(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119910-199102.2082.0511.442.212.0611.47
221717-217172.4092.41
318095-180952.0072.01
417529-175291.9441.94
518362-183622.0372.04
615505-155051.7201.72
10min179004-790048.7628.555.548.778.565.57
282330-823309.1319.14
379752-797528.8458.85
475589-755898.3848.39
575982-759828.4278.43
670065-700657.7717.77
15min1141059-14105915.64515.413.8415.6615.423.86
2143962-14396215.96715.99
3144533-14453316.03016.05
4136919-13691915.18615.20
5136377-13637715.12515.14
6130545-13054514.47914.49
20min1198850-19885022.05421.783.2022.1021.833.20
2201262-20126222.32222.37
3204275-20427522.65622.70
4193517-19351721.46321.51
5193530-19353021.46421.51
6186958-18695820.73520.78
30min1302639-30263933.56533.312.7533.6533.392.76
2303353-30335333.64533.73
3312332-31233234.64034.72
4299526-29952633.22033.30
5297127-29712732.95433.03
6287225-28722531.85631.93
45min1434107-43410748.14647.912.1448.2848.042.15
2435688-43568848.32248.46
3445770-44577049.44049.58
4429722-42972247.66047.79
5428773-42877347.55547.69
6417786-41778646.33646.46
60min1536643-53664359.51959.321.8659.7459.531.87
2536317-53631759.48259.70
3549751-54975160.97261.20
4533404-53340459.15959.37
5534100-53410059.23759.45
6518684-51868457.52757.73
极限1603417-60341766.92466.731.6167.2467.041.62
2603322-60332266.91467.23
3616112-61611268.33268.66
4602006-60200666.76867.08
5599068-59906866.44266.75
6585980-58598064.99065.29
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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数100
标示量(mg)120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%
113.439094319084749083079086859079099085610.07
213.409165699189439177560.19
单位质量响应值RSD%判断
67651.6068489.250.88数据可信
供试品溶液-24041501-1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%
5min122953-229532.5392.514.722.542.514.72
223120-231202.5582.56
322821-228212.5252.52
424019-240192.6572.66
520776-207762.2982.30
622585-225852.4982.50
10min1104208-10420811.52811.493.9811.5311.493.99
2105002-10500211.61611.62
3108414-10841411.99312.00
4107661-10766111.91011.91
598349-9834910.88010.88
699571-9957111.01511.02
15min1195089-19508921.58221.423.8621.6121.443.86
2197263-19726321.82221.85
3197393-19739321.83721.86
4202735-20273522.42822.45
5184007-18400720.35620.38
6185029-18502920.46920.49
20min1274482-27448230.36530.282.0630.4230.342.07
2274523-27452330.36930.43
3277713-27771330.72230.78
4281173-28117331.10531.17
5266106-26610629.43829.49
6268528-26852829.70629.76
30min1410913-41091345.45745.411.7245.5745.521.72
2413286-41328645.72045.83
3413217-41321745.71245.82
4420755-42075546.54646.66
5402362-40236244.51144.62
6402637-40263744.54244.65
45min1565742-56574262.58562.651.1962.7762.841.20
2567850-56785062.81863.01
3569753-56975363.02963.22
4576514-57651463.77763.97
5559284-55928461.87162.05
6558761-55876161.81361.99
60min1669795-66979574.09674.651.0474.3974.941.04
2681406-68140675.38075.67
3680491-68049175.27975.57
4680920-68092075.32775.62
5670472-67047274.17174.45
6665546-66554673.62673.91
极限1729275-72927580.67681.440.8881.0981.850.89
2740815-74081581.95382.37
3744287-74428782.33782.76
4740669-74066981.93682.36
5731209-73120980.89081.30
6730726-73072680.83681.24
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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数100
标示量(mg)120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%
113.439210589197089184969181419239689202740.26
213.409236889239679238280.03
单位质量响应值RSD%判断
68523.7568942.390.44数据可信
供试品溶液-24041501-1批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129273-292733.2074.0014.123.214.0014.10
235424-354243.8813.88
344800-448004.9084.91
438636-386364.2334.23
536557-365574.0054.01
634110-341103.7373.74
10min1143962-14396215.77216.553.7815.7816.553.78
2153577-15357716.82516.83
3155044-15504416.98616.99
4158441-15844117.35817.37
5149910-14991016.42316.43
6145225-14522515.91015.92
15min1258419-25841928.31128.802.0628.3428.842.08
2267242-26724229.27829.31
3266703-26670329.21929.26
4269180-26918029.49029.53
5259320-25932028.41028.44
6256511-25651128.10228.13
20min1359314-35931439.36539.821.7039.4439.901.70
2369228-36922840.45140.53
3365632-36563240.05740.14
4371036-37103640.64940.73
5360406-36040639.48439.57
6355246-35524638.91939.00
30min1521739-52173957.15956.382.1757.3056.522.16
2530452-53045258.11458.26
3516506-51650656.58656.74
4514683-51468356.38656.54
5502003-50200354.99755.14
6502159-50215955.01455.16
45min1673775-67377573.81674.852.0074.0675.102.00
2701769-70176976.88277.13
3694686-69468676.10776.35
4686137-68613775.17075.42
5678141-67814174.29474.53
6664981-66498172.85273.09
60min1810127-81012788.75486.872.2189.1287.242.21
2809788-80978888.71789.09
3800337-80033787.68188.05
4787010-78701086.22186.59
5785840-78584086.09386.46
6764450-76445083.75084.11
极限1846646-84664692.75590.992.6493.2791.502.64
2860427-86042794.26494.79
3836759-83675991.67192.19
4824148-82414890.29090.81
5815313-81531389.32289.83
6799959-79995987.64088.14
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T12B-A020-230703对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4对照品水分(%)0对照品稀释倍数100
标示量(mg)120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%
113.439461509475729503889546139549259507300.42
213.409717869611539664700.78
单位质量响应值RSD%判断
70791.5172124.631.32数据可信
供试品溶液-24041501-1批-pH6.8(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%
5min130472-304723.2113.9417.163.213.9417.20
238916-389164.1014.10
344937-449374.7364.74
438491-384914.0564.06
542672-426724.4974.50
629044-290443.0613.06
10min1164411-16441117.32718.316.9917.3318.317.00
2171726-17172618.09718.10
3186325-18632519.63619.64
4177927-17792718.75118.76
5185963-18596319.59819.61
6155869-15586916.42616.43
15min1298852-29885231.49532.144.0931.5332.184.09
2304170-30417032.05532.09
3315071-31507133.20433.24
4307721-30772132.42932.47
5319462-31946233.66733.71
6284549-28454929.98730.02
20min1416263-41626343.86844.053.3943.9544.143.40
2414797-41479743.71443.80
3428444-42844445.15245.25
4425086-42508644.79844.89
5431106-43110645.43245.53
6392331-39233141.34641.43
30min1582462-58246261.38361.401.9561.5461.571.95
2574390-57439060.53260.70
3582008-58200861.33561.51
4589944-58994462.17262.34
5599584-59958463.18863.36
6567435-56743559.80059.95
45min1750954-75095479.14077.821.4779.4078.091.47
2732440-73244077.18977.45
3732803-73280377.22777.50
4731929-73192977.13577.41
5753634-75363479.42279.70
6728975-72897576.82477.07
60min1841243-84124388.65586.091.6089.0586.481.59
2817537-81753786.15786.55
3808626-80862685.21885.62
4818600-81860086.26986.67
5810090-81009085.37285.78
6805135-80513584.85085.23
极限1920374-92037496.99492.432.7697.5492.972.74
2882394-88239492.99293.53
3855672-85567290.17690.72
4853796-85379689.97890.52
5875032-87503292.21692.77
6874942-87494292.20692.73
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