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T12B-A020-230703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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4561384568534575224561354573944568080.15
213.43 4555724554164554940.03
单位质量响应值RSD%判断
33887.8333916.160.06数据可信
供试品溶液-3434237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%
5min112402-124022.7303.0319.792.733.0319.82
219026-190264.1884.19
311697-116972.5752.57
413263-132632.9192.92
514221-142213.1303.13
612067-120672.6562.66
10min153984-5398411.88311.2811.8811.9111.3211.88
261877-6187713.62013.67
351883-5188311.42011.45
446953-4695310.33510.37
546442-4644210.22310.26
646462-4646210.22710.26
15min197546-9754621.47220.379.3321.6320.539.34
2106086-10608623.35223.55
395200-9520020.95521.11
484127-8412718.51818.67
587888-8788819.34619.49
684521-8452118.60518.75
20min1138381-13838130.46028.938.3630.8629.328.38
2148290-14829032.64233.10
3134816-13481629.67630.06
4123447-12344727.17327.53
5123958-12395827.28627.65
6119655-11965526.33826.69
30min1206592-20659245.47543.495.7846.2144.205.83
2210793-21079346.40047.22
3205785-20578545.29746.02
4190039-19003941.83142.49
5188337-18833741.45742.12
6183932-18393240.48741.13
45min1279190-27919061.45559.954.0462.7061.144.11
2286908-28690863.15464.49
3279193-27919361.45662.68
4263943-26394358.09959.22
5266472-26647258.65659.78
6258447-25844756.88957.98
60min1319943-31994370.42669.243.2872.3571.103.33
2322285-32228570.94172.98
3323789-32378971.27273.18
4314513-31451369.23171.00
5310692-31069268.38970.17
6296034-29603465.16366.89
极限1354805-35480578.10077.322.4980.8179.942.56
2363828-36382880.08682.91
3353847-35384777.88980.58
4352245-35224577.53680.07
5339607-33960774.75477.29
6343110-34311075.52577.97
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T12B-A020-230703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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4565254577634572344566464579244572180.14
213.43 4524364536274530320.19
单位质量响应值RSD%判断
33918.2533732.840.39数据可信
供试品溶液-3434237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%
5min136505-365058.0547.888.188.057.888.18
236002-360027.9437.94
338307-383078.4518.45
430291-302916.6836.68
538029-380298.3908.39
635107-351077.7457.75
10min1130700-13070028.83528.593.5928.9228.683.60
2129938-12993828.66728.76
3132875-13287529.31529.41
4120446-12044626.57326.65
5132899-13289929.32029.41
6130597-13059728.81228.90
15min1212073-21207346.78745.643.4747.2046.053.48
2208101-20810145.91146.32
3207047-20704745.67846.10
4194775-19477542.97143.34
5215449-21544947.53247.95
6203873-20387344.97845.38
20min1263100-26310058.04558.331.8658.9759.241.88
2265581-26558158.59259.51
3264691-26469158.39659.32
4258853-25885357.10857.95
5273034-27303460.23661.18
6260989-26098957.57958.49
30min1338020-33802074.57474.241.9876.1575.801.98
2338266-33826674.62876.20
3329221-32922172.63274.21
4329177-32917772.62374.10
5346852-34685276.52278.14
6337473-33747374.45376.00
45min1387456-38745685.48085.632.0387.8888.012.02
2386017-38601785.16387.56
3384922-38492284.92187.30
4376440-37644083.05085.34
5397271-39727187.64690.11
6396655-39665587.51089.88
60min1408983-40898390.22990.471.7893.5893.811.77
2401694-40169488.62191.96
3410056-41005690.46693.79
4402873-40287388.88192.09
5419274-41927492.50095.94
6417639-41763992.13995.48
极限1417876-41787692.19193.701.8496.5598.051.83
2425979-42597993.97998.31
3418709-41870992.37596.71
4419261-41926192.49796.70
5437974-43797496.625101.09
6428621-42862194.56298.93
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T12B-A020-230703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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4557634536074547674567084543264550340.27
213.43 4527574524724526140.05
单位质量响应值RSD%判断
33756.2333701.710.12数据可信
供试品溶液-3434237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%
5min169426-6942615.36014.7518.4015.3614.7518.41
287543-8754319.36919.37
363129-6312913.96713.97
456773-5677312.56112.56
553024-5302411.73211.73
670193-7019315.53015.53
10min1176935-17693539.14738.506.4739.3238.666.51
2192858-19285842.67042.88
3163641-16364136.20536.36
4168193-16819337.21337.35
5163736-16373636.22636.36
6178625-17862539.52139.69
15min1253961-25396156.18956.375.7856.7956.965.82
2278961-27896161.72062.41
3246317-24631754.49755.05
4248142-24814254.90155.45
5237547-23754752.55753.09
6263881-26388158.38359.00
20min1302898-30289867.01667.133.0868.2568.353.15
2317500-31750070.24771.62
3295895-29589565.46766.63
4306715-30671567.86069.02
5290838-29083864.34865.46
6306698-30669867.85769.12
30min1359648-35964879.57280.733.0581.5582.693.09
2386146-38614685.43487.59
3362437-36243780.18982.08
4366724-36672481.13783.05
5354843-35484378.50980.34
6359489-35948979.53781.55
45min1396511-39651187.72889.341.9390.5992.201.99
2416752-41675292.20695.31
3403807-40380789.34292.12
4407856-40785690.23893.06
5396006-39600687.61690.32
6401815-40181588.90191.80
60min1412387-41238791.24092.401.2295.0796.261.26
2424403-42440393.89998.03
3422673-42267393.51697.29
4418591-41859192.61396.43
5414628-41462891.73695.41
6413209-41320991.42295.31
极限1404085-40408589.40394.013.0494.2598.892.96
2441871-44187197.764102.94
3423434-42343493.68498.50
4422356-42235693.44698.30
5434821-43482196.204100.90
6422859-42285993.55798.46
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T12B-A020-230703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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4549434539604535074527984540364538490.18
213.43 4505874523714514790.28
单位质量响应值RSD%判断
33668.3233617.200.11数据可信
供试品溶液-3434237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%
5min183099-8309918.43317.0814.0818.4317.0814.09
283716-8371618.57018.57
371855-7185515.93915.94
491054-9105420.19720.20
561464-6146413.63413.63
670722-7072215.68715.69
10min1198947-19894744.13043.424.3344.3343.614.36
2201281-20128144.64744.85
3193404-19340442.90043.08
4207352-20735245.99446.22
5189654-18965442.06842.22
6183932-18393240.79940.97
15min1272536-27253660.45358.933.4561.1559.603.46
2274687-27468760.93061.63
3262461-26246158.21858.87
4269048-26904859.67960.41
5266107-26610759.02759.65
6249262-24926255.29055.92
20min1320742-32074271.14669.744.0572.5171.064.05
2329933-32993373.18474.56
3315531-31553169.99071.29
4318384-31838470.62372.02
5309415-30941568.63369.91
6292344-29234464.84766.09
30min1379134-37913484.09882.124.4086.2684.224.39
2381020-38102084.51686.71
3377723-37772383.78585.86
4380073-38007384.30686.49
5363516-36351680.63482.67
6339737-33973775.35977.32
45min1419006-41900692.94290.573.7096.0393.593.70
2416946-41694692.48595.62
3421798-42179893.56296.57
4409514-40951490.83793.96
5401083-40108388.96791.90
6381614-38161484.64887.45
60min1441638-44163897.96293.984.05102.0998.004.04
2430731-43073195.54399.70
3428067-42806794.95299.00
4433167-43316796.083100.21
5415056-41505692.06695.99
6393478-39347887.28091.02
极限1443878-44387898.45995.652.49103.67100.722.55
2435813-43581396.670101.89
3437271-43727196.994102.10
4432813-43281396.005101.20
5423620-42362093.96698.91
6413998-41399891.83196.54
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T12B-A020-230703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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.48 4525434527424538324515764522544525890.19
213.43 4537264534204535730.05
单位质量响应值RSD%判断
33574.8533773.120.42数据可信
供试品溶液-3434237批-pH6.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144996-449969.9729.595.009.979.595.00
241418-414189.1799.18
342790-427909.4839.48
444711-447119.9099.91
545581-4558110.10110.10
640223-402238.9148.91
10min1140358-14035831.10530.054.8031.2230.164.80
2125924-12592427.90628.01
3134003-13400329.69729.80
4137069-13706930.37630.49
5144319-14431931.98332.10
6131859-13185929.22229.32
15min1211041-21104146.76945.184.2847.2345.624.26
2196371-19637143.51843.93
3193224-19322442.82143.26
4198872-19887244.07244.52
5213450-21345047.30347.77
6210358-21035846.61847.04
20min1263527-26352758.40156.703.8859.3857.643.87
2242562-24256253.75554.65
3244928-24492854.27955.19
4264113-26411358.53159.47
5264109-26410958.53059.52
6255785-25578556.68557.63
30min1325702-32570272.18070.852.9473.8072.422.95
2308026-30802668.26269.76
3307192-30719268.07769.59
4324926-32492672.00873.60
5326013-32601372.24873.89
6326299-32629972.31273.88
45min1379658-37965884.13781.983.3086.5684.333.29
2358063-35806379.35181.60
3351306-35130677.85480.12
4378983-37898383.98786.37
5373341-37334182.73785.18
6378097-37809783.79186.17
60min1407166-40716690.23388.112.7393.5991.382.74
2387934-38793485.97189.10
3380996-38099684.43387.57
4402768-40276889.25892.58
5399149-39914988.45691.82
6407520-40752090.31193.62
极限1414685-41468591.89991.811.4396.2696.061.35
2414984-41498491.96696.05
3415404-41540492.05996.13
4406550-40655090.09694.41
5410014-41001490.86495.21
6423978-42397893.95998.27
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