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%
113.784535624538994538404540564531504537010.08
213.814541294529194535240.19
单位质量响应值RSD%判断
32924.6032840.260.19数据可信
供试品溶液-2024102421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%
5min14263-42630.9672.0562.140.972.0662.07
219915-199154.5204.52
37938-79381.8011.80
46069-60691.3771.38
59640-96402.1882.19
66481-64811.4711.47
10min128812-288126.5398.2226.476.558.2526.54
254385-5438512.34212.39
337996-379968.6238.64
432225-322257.3137.33
535181-351817.9848.01
628820-288206.5416.56
15min152978-5297812.02314.5020.6612.1114.6220.75
288402-8840220.06220.25
367274-6727415.26815.38
459096-5909613.41213.51
562432-6243214.16914.28
653186-5318612.07012.16
20min179064-7906417.94320.8117.4418.1621.0917.55
2120278-12027827.29727.71
398939-9893922.45422.74
485230-8523019.34319.59
589275-8927520.26120.53
677487-7748717.58517.81
30min1122501-12250127.80131.9913.9528.2232.5014.06
2173739-17373939.42940.14
3153522-15352234.84135.38
4135736-13573630.80531.27
5137140-13714031.12331.62
6123150-12315027.94828.37
45min1190461-19046143.22447.039.0643.9547.899.22
2235681-23568153.48754.64
3224520-22452050.95451.88
4201492-20149245.72846.53
5201401-20140145.70746.55
6189815-18981543.07843.81
60min1237835-23783553.97657.427.1155.1858.817.29
2282622-28262264.14065.89
3266389-26638960.45661.94
4246603-24660355.96557.28
5247902-24790256.26057.61
6236814-23681453.74454.95
极限1274896-27489662.38665.744.9264.1967.775.13
2310596-31059670.48872.95
3300334-30033468.15970.32
4289283-28928365.65167.58
5288927-28892765.57167.54
6274135-27413562.21464.02
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%
113.784533984557824532074532274534074538040.25
213.814538294549754544020.18
单位质量响应值RSD%判断
32932.0832903.840.07数据可信
供试品溶液-2024102421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%
5min13182-31820.7211.31116.290.721.31116.33
2-0.0000.00
315879-158793.6003.60
4-0.0000.00
53223-32230.7310.73
612315-123152.7922.79
10min123280-232805.2786.0941.155.296.1041.35
220306-203064.6034.60
345121-4512110.22910.27
414749-147493.3443.34
523033-230335.2225.23
634567-345677.8367.87
15min150779-5077911.51212.2224.7011.5812.3024.87
248190-4819010.92510.98
378538-7853817.80517.96
440229-402299.1209.16
547974-4797410.87610.94
657636-5763613.06613.18
20min173703-7370316.70817.6018.1816.9017.8218.39
273700-7370016.70816.88
3103658-10365823.49923.85
462663-6266314.20614.34
570650-7065016.01616.20
681454-8145418.46618.73
30min1119596-11959627.11228.6612.5627.4929.0712.74
2127896-12789628.99429.35
3155671-15567135.29135.90
4110572-11057225.06725.36
5116443-11644326.39826.76
6128299-12829929.08529.55
45min1186373-18637342.25143.087.1242.9343.817.33
2190800-19080043.25443.93
3215251-21525148.79749.80
4177495-17749540.23840.81
5179742-17974240.74841.41
6190542-19054243.19643.99
60min1236248-23624853.55754.623.9354.7155.834.15
2244775-24477555.49056.65
3257009-25700958.26459.81
4229094-22909451.93652.96
5237447-23744753.82954.94
6241058-24105854.64855.92
极限1274797-27479762.29663.112.8764.0464.933.09
2282008-28200863.93165.71
3291857-29185766.16468.36
4269281-26928161.04662.65
5273182-27318261.93063.64
6279294-27929463.31665.19
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%
113.784527594517484542904518144516834524590.25
213.814552944523084538010.47
单位质量响应值RSD%判断
32834.4732860.320.06数据可信
供试品溶液-2024102521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%
5min18471-84711.9251.6543.811.921.6543.79
29561-95612.1722.17
38238-82381.8721.87
41639-16390.3720.37
55529-55291.2561.26
610133-101332.3022.30
10min133103-331037.5216.4220.487.546.4420.53
232300-323007.3387.36
332576-325767.4017.42
419611-196114.4554.46
522534-225345.1195.13
629431-294316.6866.71
15min161250-6125013.91511.9115.1914.0212.0015.23
257436-5743613.04913.15
358224-5822413.22813.33
442397-423979.6329.69
543533-435339.8909.96
651698-5169811.74511.84
20min186803-8680319.72117.3712.4219.9817.5912.49
281054-8105418.41418.67
385647-8564719.45819.71
466930-6693015.20615.37
564679-6467914.69414.87
673592-7359216.71916.95
30min1139430-13943031.67728.6310.6332.1629.0410.68
2136997-13699731.12431.58
3136785-13678531.07631.54
4114532-11453226.02026.35
5108428-10842824.63324.98
6119885-11988527.23627.65
45min1205607-20560746.71143.157.8847.5443.897.96
2201500-20150045.77846.58
3201043-20104345.67446.49
4180410-18041040.98741.61
5168051-16805138.17938.80
6183030-18303041.58242.30
60min1256270-25627058.22154.496.6159.5755.706.69
2252117-25211757.27858.59
3250789-25078956.97658.29
4234185-23418553.20454.28
5215513-21551348.96250.00
6230302-23030252.32253.50
极限1286172-28617265.01562.105.4267.0163.925.52
2279054-27905463.39765.34
3290445-29044565.98567.94
4265225-26522560.25661.92
5250585-25058556.93058.52
6268660-26866061.03662.80
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%
113.784547024548034563314517194534764542060.38
213.814522314538534530420.26
单位质量响应值RSD%判断
32961.2532805.360.34数据可信
供试品溶液-2024102521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%
5min12476-24760.5622.0947.940.562.0948.00
213587-135873.0833.08
38921-89212.0252.02
45785-57851.3131.31
513409-134093.0433.04
611187-111872.5392.54
10min124245-242455.5027.3020.875.517.3220.93
241265-412659.3659.40
333268-332687.5507.57
424282-242825.5115.53
535588-355888.0768.11
634292-342927.7827.81
15min150546-5054611.47113.2514.9711.5413.3515.03
271666-7166616.26416.40
360411-6041113.71013.82
447014-4701410.66910.75
561487-6148713.95414.08
659129-5912913.41913.53
20min178250-7825017.75819.1411.9817.9519.4012.07
2100937-10093722.90723.23
386590-8659019.65119.91
470572-7057216.01616.21
586037-8603719.52519.80
683758-8375819.00819.27
30min1131923-13192329.93930.499.1330.3330.959.22
2155429-15542935.27335.85
3135839-13583930.82731.30
4118184-11818426.82127.19
5136231-13623130.91631.41
6128443-12844329.14929.62
45min1196352-19635244.56045.305.5745.2846.105.68
2219781-21978149.87750.84
3198393-19839345.02345.84
4185671-18567142.13642.81
5199808-19980845.34446.18
6197719-19771944.87045.67
60min1244769-24476955.54855.884.1556.7757.194.26
2264595-26459560.04761.57
3243727-24372755.31156.63
4234340-23434053.18154.32
5241039-24103954.70156.04
6249021-24902156.51357.81
极限1277552-27755262.98863.602.7664.8265.522.90
2293601-29360166.63068.82
3277140-27714062.89464.83
4270749-27074961.44463.17
5278914-27891463.29765.25
6283421-28342164.32066.24
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