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)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%
113.474538924535664525994533464533634533530.11
213.494497364510354503860.21
单位质量响应值RSD%判断
33656.5033386.660.57数据可信
供试品溶液-2024102621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%
5min147086-4708610.4829.0540.2510.489.0540.27
262416-6241613.89513.90
344027-440279.8019.80
413440-134402.9922.99
544172-441729.8349.83
632900-329007.3247.32
10min1150317-15031733.46431.4215.1633.5831.5215.24
2163108-16310836.31136.47
3147575-14757532.85332.96
4103311-10331122.99923.03
5152453-15245333.93934.05
6130185-13018528.98229.06
15min1226351-22635150.39149.727.5850.8850.177.69
2238052-23805252.99553.55
3228878-22887850.95351.43
4191671-19167142.67042.96
5235855-23585552.50652.99
6219314-21931448.82449.23
20min1284254-28425463.28163.674.7864.3364.674.88
2289431-28943164.43465.58
3291409-29140964.87465.91
4262765-26276558.49759.26
5304498-30449867.78868.86
6283543-28354363.12364.07
30min1345817-34581776.98679.743.1978.7481.453.24
2357581-35758179.60581.47
3362020-36202080.59382.35
4348290-34829077.53778.95
5377837-37783784.11585.94
6357490-35749079.58581.23
45min1413545-41354592.06493.062.2394.6795.662.21
2411108-41110891.52194.27
3410393-41039391.36294.02
4415261-41526192.44694.72
5434461-43446196.72099.48
6423292-42329294.23496.77
60min1419680-41968093.43097.473.3397.06101.103.24
2428738-42873895.44699.21
3429598-42959895.63899.31
4440682-44068298.105101.41
5458792-458792102.137105.97
6449464-449464100.060103.64
极限1450971-450971100.396100.572.50105.06105.282.44
2439491-43949197.840102.66
3439850-43985097.920102.65
4452414-452414100.717105.11
5468741-468741104.352109.32
6459122-459122102.210106.90
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)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%
113.474533944539984541204536304538584538000.07
213.494521564529614525580.13
单位质量响应值RSD%判断
33689.6833547.660.30数据可信
供试品溶液-2024102621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%
5min135052-350527.7819.5414.547.789.5414.56
251470-5147011.42511.43
342296-422969.3899.39
449294-4929410.94210.94
539210-392108.7048.70
640588-405889.0109.01
10min1132797-13279729.47830.956.0329.5631.056.06
2147596-14759632.76332.89
3140066-14006631.09131.20
4151152-15115233.55233.67
5134275-13427529.80629.90
6130614-13061428.99329.09
15min1205806-20580645.68448.234.1046.1048.684.12
2221133-22113349.08649.58
3221418-22141849.14949.60
4229365-22936550.91351.41
5217783-21778348.34348.77
6208059-20805946.18446.61
20min1268074-26807459.50660.923.4960.4361.913.50
2269501-26950159.82360.86
3278544-27854461.83062.83
4290877-29087764.56865.63
5275553-27555361.16662.13
6264211-26421158.64859.58
30min1336862-33686274.77578.012.9776.3679.672.98
2347475-34747577.13178.83
3352895-35289578.33480.02
4366321-36632181.31483.09
5359162-35916279.72581.37
6345813-34581376.76278.35
45min1396161-39616187.93890.542.0290.3593.072.03
2400214-40021488.83891.40
3410297-41029791.07693.63
4418157-41815792.82195.50
5413051-41305191.68794.22
6409505-40950590.90093.34
60min1410721-41072191.17095.352.6794.5698.882.66
2426015-42601594.56598.11
3426156-42615694.59698.16
4442874-44287498.307102.02
5439087-43908797.467101.02
6432369-43236995.97599.43
极限1443604-44360498.46998.950.60102.87103.550.68
2442531-44253198.231102.83
3447915-44791599.426104.04
4449519-44951999.782104.59
5446304-44630499.069103.70
6444828-44482898.741103.26
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)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%
113.474526534529194528624533994526814529030.07
213.494508464497604503030.18
单位质量响应值RSD%判断
33623.0933380.500.52数据可信
供试品溶液-M2449M1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%
5min165185-6518514.52013.4816.2514.5213.4816.24
254886-5488612.22612.23
345761-4576110.19310.19
474946-7494616.69416.69
559962-5996213.35713.36
662317-6231713.88113.88
10min1192247-19224742.82340.246.2842.9840.396.31
2169807-16980737.82537.96
3167470-16747037.30437.42
4195094-19509443.45843.64
5177852-17785239.61739.77
6181329-18132940.39140.55
15min1263404-26340458.67456.364.4859.3156.964.52
2248182-24818255.28355.84
3234576-23457652.25252.78
4264504-26450458.91959.59
5249477-24947755.57256.16
6258077-25807757.48758.09
20min1310805-31080569.23266.453.8670.5267.673.90
2289049-28904964.38665.56
3284019-28401963.26664.37
4309619-30961968.96870.29
5291550-29155064.94366.15
6304738-30473867.88169.12
30min1363986-36398681.07979.571.9583.1481.542.02
2354805-35480579.03480.92
3349661-34966177.88879.70
4363696-36369681.01483.10
5349112-34911277.76579.69
6362104-36210480.65982.66
45min1405394-40539490.30288.092.4893.2690.942.50
2399000-39900088.87891.64
3385362-38536285.84088.52
4397282-39728288.49591.48
5381681-38168185.02087.81
6404067-40406790.00792.90
60min1422206-42220694.04791.701.6898.0195.531.71
2408950-40895091.09594.85
3407978-40797890.87894.51
4407855-40785590.85194.82
5404774-40477490.16493.90
6418346-41834693.18797.08
极限1440007-44000798.01394.742.15103.0299.582.14
2428357-42835795.417100.18
3422085-42208594.02098.66
4427880-42788095.311100.29
5413148-41314892.03096.77
6420302-42030293.62398.55
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)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%
113.474528724533254540714529554540594534560.13
213.494523824535304529560.18
单位质量响应值RSD%判断
33664.1433577.170.19数据可信
供试品溶液-M2449M1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%
5min145506-4550610.10113.2118.3610.1013.2118.36
256785-5678512.60412.60
372119-7211916.00816.01
448555-4855510.77710.78
566325-6632514.72214.72
667698-6769815.02615.03
10min1167293-16729337.13339.595.3437.2439.745.37
2178057-17805739.52239.66
3195784-19578443.45743.63
4174198-17419838.66538.79
5175600-17560038.97739.14
6179324-17932439.80339.97
15min1243662-24366254.08455.683.0854.6156.273.11
2248930-24893055.25355.83
3264371-26437158.68059.34
4253763-25376356.32656.88
5243657-24365754.08354.68
6250791-25079155.66656.28
20min1288721-28872164.08565.952.6665.2167.162.68
2298269-29826966.20467.40
3310461-31046168.91170.22
4300630-30063066.72867.90
5293495-29349565.14566.34
6291182-29118264.63165.86
30min1349870-34987077.65878.582.3279.5080.522.31
2351711-35171178.06780.00
3364129-36412980.82382.90
4364494-36449480.90482.82
5347965-34796577.23579.16
6346020-34602076.80378.75
45min1397712-39771288.27787.821.6390.9890.631.57
2395638-39563887.81790.61
3395848-39584887.86390.84
4393226-39322687.28190.10
5405678-40567890.04592.82
6385845-38584585.64388.44
60min1411138-41113891.25791.622.2194.9495.402.16
2408580-40858090.68994.46
3418922-41892292.98596.94
4420633-42063393.36597.15
5420025-42002593.23097.01
6397258-39725888.17691.93
极限1418833-41883392.96594.562.0097.6699.362.00
2422097-42209793.69098.47
3436584-43658496.905101.89
4429662-42966295.369100.19
5433508-43350896.222101.04
6415312-41531292.18496.91
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