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%
113.364530634535454537014531064533454533520.07
213.404560874536394548630.39
单位质量响应值RSD%判断
33933.5333945.000.03数据可信
长期6月-供试品溶液-2024102421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%
5min175724-7572416.65016.5911.9016.6516.5911.89
275651-7565116.63416.63
374245-7424516.32516.32
480693-8069317.74317.74
559696-5969613.12613.13
686652-8665219.05319.05
10min1185402-18540240.76642.653.2640.9542.833.27
2189247-18924741.61141.80
3194941-19494142.86343.04
4195848-19584843.06343.26
5194425-19442542.75042.90
6203907-20390744.83545.05
15min1254401-25440155.93757.603.0856.5858.263.07
2250558-25055855.09255.74
3260894-26089457.36558.02
4269292-26929259.21159.89
5267707-26770758.86359.48
6268949-26894959.13659.85
20min1294224-29422464.69367.482.8565.9568.782.82
2304051-30405166.85468.11
3310590-31059068.29269.59
4300826-30082666.14567.48
5317051-31705169.71370.99
6314599-31459969.17370.54
30min1337679-33767974.24878.603.0476.2380.643.01
2353158-35315877.65279.65
3368584-36858481.04483.10
4361313-36131379.44581.51
5362013-36201379.59981.65
6362000-36200079.59681.73
45min1376260-37626082.73185.952.7385.5388.872.71
2386917-38691785.07587.94
3398100-39810087.53390.49
4382247-38224784.04887.00
5398681-39868187.66190.60
6403155-40315588.64591.66
60min1398299-39829987.57791.732.4691.3095.602.44
2416025-41602591.47595.28
3416459-41645991.57095.50
4428054-42805494.12098.00
5421243-42124392.62296.53
6422904-42290492.98796.99
极限1409680-40968090.08093.662.4594.7898.562.45
2420302-42030292.41597.24
3429175-42917594.36699.31
4424937-42493793.43498.37
5431425-43142594.86199.80
6440294-44029496.811101.85
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%
113.364498784498504513734513634515414508010.20
213.404557534552704555120.08
单位质量响应值RSD%判断
33742.5933993.430.53数据可信
长期6月-供试品溶液-2024102421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%
5min168091-6809115.00314.9720.4715.0014.9720.47
250949-5094911.22611.23
380146-8014617.66017.66
463614-6361414.01714.02
587722-8772219.32919.33
657041-5704112.56912.57
10min1185711-18571140.92034.5447.8341.0934.7147.63
2178887-17888739.41739.54
3193384-19338442.61142.81
45603-56031.2351.39
5205398-20539845.25845.47
6171533-17153337.79637.94
15min1253793-25379355.92257.163.3956.5457.703.39
2264173-26417358.20958.77
3260745-26074557.45458.12
4262565-26256557.85558.02
5270101-27010159.51560.23
6245046-24504653.99454.55
20min1297639-29763965.58366.633.5266.8367.823.53
2300577-30057766.23067.44
3312066-31206668.76270.07
4306384-30638467.51068.32
5313056-31305668.98070.36
6284624-28462462.71563.87
30min1341466-34146675.24078.392.8077.2180.312.72
2364843-36484380.39182.34
3356675-35667578.59180.66
4363818-36381880.16581.73
5362106-36210679.78881.93
6345602-34560276.15178.01
45min1368471-36847181.19085.903.0084.0088.702.88
2390006-39000685.93588.77
3392934-39293486.58189.53
4401649-40164988.50190.95
5398281-39828187.75990.79
6387793-38779385.44888.15
60min1394060-39406086.82990.933.0090.5494.682.81
2421042-42104292.77496.57
3408687-40868790.05293.96
4430686-43068694.89998.34
5411657-41165790.70694.71
6409808-40980890.29993.95
极限1414764-41476491.39195.722.8896.06100.482.68
2434574-43457495.756100.58
3430285-43028594.81199.72
4453479-45347999.921104.41
5435694-43569496.002101.02
6437555-43755596.412101.07
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%
113.364545754547194554804561534560524553960.17
213.404524894530224527560.09
单位质量响应值RSD%判断
34086.5333787.760.63数据可信
长期6月-供试品溶液-2024102521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%
5min178707-7870717.30715.7015.0817.3115.7015.09
271558-7155815.73515.74
375266-7526616.55116.55
484626-8462618.60918.61
555071-5507112.11012.11
663069-6306913.86913.87
10min1190954-19095441.99039.844.7242.1840.024.75
2174169-17416938.29938.47
3178326-17832639.21339.40
4191566-19156642.12542.33
5170951-17095137.59137.73
6181149-18114939.83439.99
15min1259557-25955757.07655.492.2257.7356.102.26
2249194-24919454.79755.40
3246343-24634354.17054.79
4257093-25709356.53457.21
5246898-24689854.29254.84
6254892-25489256.05056.65
20min1304489-30448966.95664.972.6168.2566.212.59
2291735-29173564.15165.36
3287542-28754263.22964.45
4301021-30102166.19367.50
5301202-30120266.23367.39
6286855-28685563.07864.30
30min1348852-34885276.71175.411.2678.7577.361.31
2340408-34040874.85476.78
3344836-34483675.82877.75
4345980-34598076.08078.12
5337345-33734574.18176.07
6340148-34014874.79776.72
45min1375552-37555282.58284.241.6485.4787.031.57
2381240-38124083.83386.59
3376376-37637682.76485.53
4387417-38741785.19188.08
5387532-38753285.21787.93
6390406-39040685.84988.60
60min1408862-40886289.90789.161.3593.7192.891.35
2396513-39651387.19290.88
3403290-40329088.68292.37
4411975-41197590.59294.42
5408331-40833189.79093.45
6403942-40394288.82592.53
极限1433390-43339095.30193.521.40100.1198.241.36
2416295-41629591.54296.20
3427729-42772994.05698.73
4422587-42258792.92597.76
5428628-42862894.25498.91
6423142-42314293.04797.74
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%
113.364519104525274520454527194522984523000.08
213.404537694487514512600.79
单位质量响应值RSD%判断
33854.7933676.120.38数据可信
长期6月-供试品溶液-2024102521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%
5min172680-7268016.06316.239.9116.0616.229.91
271611-7161115.82715.83
363442-6344214.02114.02
485158-8515818.82118.82
577200-7720017.06217.06
670424-7042415.56515.56
10min1184577-18457740.79441.705.3740.9741.885.38
2189862-18986241.96242.14
3178465-17846539.44339.60
4205397-20539745.39545.60
5194021-19402142.88143.07
6179660-17966039.70739.88
15min1255638-25563856.49957.644.8657.1358.294.87
2266719-26671958.94859.59
3246356-24635654.44755.04
4279255-27925561.71962.43
5267976-26797659.22659.89
6248996-24899655.03155.65
20min1296317-29631765.48966.624.0166.7567.914.03
2311180-31118068.77470.07
3289910-28991064.07365.27
4311603-31160368.86870.27
5313401-31340169.26570.59
6286303-28630363.27664.50
30min1354378-35437878.32279.142.7480.3181.172.79
2365377-36537780.75382.81
3349029-34902977.13979.05
4368001-36800181.33283.50
5366497-36649781.00083.09
6345319-34531976.31978.25
45min1398954-39895488.17387.763.1091.0390.663.11
2411399-41139990.92493.88
3380238-38023884.03786.80
4403114-40311489.09392.16
5404626-40462689.42792.42
6384108-38410884.89287.67
60min1416141-41614191.97291.372.8095.8195.252.79
2426149-42614994.18498.15
3407726-40772690.11293.81
4410649-41064990.75894.82
5424723-42472393.86997.86
6395243-39524387.35391.07
极限1417246-41724692.21694.041.8397.0898.941.88
2434270-43427095.979100.99
3420307-42030792.89397.60
4429611-42961194.949100.02
5433295-43329595.763100.79
6418363-41836392.46397.15
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%
113.364528594525354527154526544526814526890.03
213.404574414557404565900.27
单位质量响应值RSD%判断
33883.9134073.880.40数据可信
长期6月-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%
5min174676-7467616.40114.4613.8816.4014.4613.89
266206-6620614.54014.54
362207-6220713.66213.66
477663-7766317.05717.06
561343-6134313.47213.47
652960-5296011.63111.63
10min1176198-17619838.69737.956.9638.8838.126.98
2174338-17433838.28938.45
3177638-17763839.01339.17
4187008-18700841.07141.26
5170835-17083537.51937.67
6150892-15089233.13933.27
15min1236895-23689552.02851.145.9352.6451.725.96
2228594-22859450.20550.79
3238854-23885452.45853.04
4248600-24860054.59855.24
5236200-23620051.87552.44
6207888-20788845.65746.15
20min1277431-27743160.93061.555.3962.1262.705.41
2280599-28059961.62662.77
3294166-29416664.60665.77
4295310-29531064.85766.11
5280439-28043961.59162.73
6253588-25358855.69456.70
30min1337192-33719274.05573.873.9375.9275.703.97
2343435-34343575.42677.26
3347941-34794176.41678.30
4345339-34533975.84577.82
5331857-33185772.88474.71
6312205-31220568.56870.19
45min1361510-36151079.39682.613.5682.0985.273.58
2382647-38264784.03886.71
3390175-39017585.69288.43
4388801-38880185.39088.21
5374224-37422482.18884.83
6359441-35944178.94281.33
60min1388357-38835785.29287.223.3788.8690.803.40
2408775-40877589.77793.38
3411785-41178590.43894.12
4405887-40588789.14292.91
5388930-38893085.41888.97
6379154-37915483.27186.53
极限1401551-40155188.19091.362.6992.7195.902.67
2422676-42267692.83097.43
3433302-43330295.16399.86
4413023-41302390.70995.46
5417120-41712091.60996.11
6408130-40813089.63593.82
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%
113.364552534535654547414547964548734546460.14
213.404599144589204594170.16
单位质量响应值RSD%判断
34030.3934284.850.53数据可信
长期6月-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%
5min154738-5473811.95914.6715.7911.9614.6715.77
258958-5895812.88112.88
373789-7378916.12116.12
480438-8043817.57417.57
559755-5975513.05513.06
675223-7522316.43416.43
10min1146638-14663832.03737.439.5332.1737.609.55
2169318-16931836.99237.13
3187502-18750240.96541.14
4189998-18999841.51041.71
5161136-16113635.20435.35
6173459-17345937.89738.08
15min1204786-20478644.74152.219.3345.2352.799.35
2237134-23713451.80852.36
3253648-25364855.41656.05
4269784-26978458.94159.60
5227056-22705649.60650.14
6241508-24150852.76453.37
20min1248459-24845954.28262.187.9455.2763.347.97
2284237-28423762.09963.23
3299334-29933465.39766.65
4312041-31204168.17369.48
5270501-27050159.09860.19
6293115-29311564.03865.23
30min1333996-33399672.97073.646.9874.5675.496.94
2298350-29835065.18267.00
3355562-35556277.68279.66
4366541-36654180.08082.15
5330346-33034672.17373.92
6337531-33753173.74275.64
45min1361007-36100778.87184.144.3981.2786.814.49
2378196-37819682.62785.17
3398954-39895487.16290.00
4402105-40210587.85090.81
5372624-37262481.40983.96
6397877-39787786.92689.65
60min1377092-37709282.38587.673.3785.6691.273.46
2406040-40604088.71092.17
3405424-40542488.57592.38
4418167-41816791.35995.29
5401660-40166087.75391.20
6399349-39934987.24890.93
极限1418907-41890791.52194.062.9395.7198.642.82
2421575-42157592.10496.55
3435993-43599395.254100.05
4422143-42214392.22897.18
5452322-45232298.821103.25
6432256-43225694.43799.09
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