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%
113.489331219341969347849339369341809340430.07
213.509333029344729338870.09
单位质量响应值RSD%判断
69291.0269176.810.12数据可信
供试品溶液-24041501-1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112713-127131.3831.238.501.381.238.57
29776-97761.0631.06
311552-115521.2561.26
411469-114691.2471.25
510885-108851.1841.18
611383-113831.2381.24
10min136074-360743.9233.743.703.933.743.75
233778-337783.6743.68
335532-355323.8653.87
434407-344073.7423.74
534037-340373.7023.70
632542-325423.5393.54
15min157554-575546.2606.062.966.276.072.99
255342-553426.0196.03
357635-576356.2686.28
455451-554516.0316.04
555071-550715.9906.00
653289-532895.7965.80
20min177585-775858.4388.212.888.468.222.88
275395-753958.2008.22
378200-782008.5058.52
474906-749068.1478.17
574312-743128.0828.10
672314-723147.8657.88
30min1114533-11453312.45712.202.2312.4912.242.24
2112022-11202212.18412.22
3115527-11552712.56512.60
4111196-11119612.09412.13
5111394-11139412.11512.15
6108587-10858711.81011.84
45min1167736-16773618.24317.822.1418.3017.872.15
2164180-16418017.85717.91
3167837-16783718.25418.31
4161884-16188417.60717.66
5162529-16252917.67717.73
6158894-15889417.28217.33
60min1215838-21583823.47523.061.8923.5623.141.90
2212840-21284023.14923.23
3216926-21692623.59323.68
4209246-20924622.75822.84
5211102-21110222.96023.04
6206342-20634222.44222.52
极限1249900-24990027.18026.831.5827.3026.951.58
2247478-24747826.91627.04
3251656-25165627.37127.49
4243776-24377626.51426.63
5246337-24633726.79226.91
6241095-24109526.22226.34
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%
113.489294959289279275309279319285749284910.09
213.509292979293759293360.01
单位质量响应值RSD%判断
68879.1568839.700.05数据可信
供试品溶液-24041501-1批-pH4.5(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%
5min113723-137231.5011.5710.251.501.5710.45
216151-161511.7661.77
315514-155141.6971.70
412755-127551.3951.39
512809-128091.4011.40
615324-153241.6761.68
10min150348-503485.5065.615.775.515.625.75
254698-546985.9815.98
355001-550016.0156.02
448256-482565.2775.28
548424-484245.2955.30
651223-512235.6015.60
15min185844-858449.3879.544.679.409.554.67
291443-9144310.00010.01
392980-9298010.16810.18
483522-835229.1339.14
583379-833799.1189.13
686061-860619.4119.42
20min1120119-12011913.13513.284.0413.1613.304.04
2126143-12614313.79413.82
3128816-12881614.08614.12
4117645-11764512.86512.89
5116891-11689112.78212.81
6118885-11888513.00013.03
30min1182115-18211519.91520.163.8219.9620.203.82
2190751-19075120.85920.91
3195231-19523121.34921.40
4178017-17801719.46719.51
5178623-17862319.53319.58
6181245-18124519.82019.87
45min1268392-26839229.35029.653.2929.4329.733.28
2278152-27815230.41730.50
3285792-28579231.25231.34
4263342-26334228.79728.88
5265396-26539629.02229.10
6265621-26562129.04729.13
60min1344016-34401637.61938.072.9037.7538.202.90
2354537-35453738.77038.91
3365782-36578239.99940.14
4339808-33980837.15937.29
5342408-34240837.44337.57
6342176-34217637.41837.55
极限1399131-39913143.64643.982.7143.8444.182.72
2407985-40798544.61444.82
3421729-42172946.11746.33
4393189-39318942.99643.19
5396630-39663043.37343.56
6394616-39461643.15343.35
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%
113.489320169323649323309319479306589318630.08
213.509423349417589420460.05
单位质量响应值RSD%判断
69129.3069781.190.67数据可信
供试品溶液-24041501-124041501-1批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112133-121331.3151.273.111.321.273.15
211890-118901.2891.29
311837-118371.2831.28
411657-116571.2641.26
511689-116891.2671.27
611053-110531.1981.20
10min115807-158071.7141.672.741.721.682.75
215795-157951.7121.71
315596-155961.6911.69
415567-155671.6881.69
515145-151451.6421.64
614731-147311.5971.60
15min118713-187132.0291.991.852.032.001.83
218570-185702.0132.02
318381-183811.9932.00
418701-187012.0282.03
518167-181671.9701.97
617846-178461.9351.94
20min121580-215802.3402.301.902.352.311.95
221081-210812.2862.29
321434-214342.3242.33
421666-216662.3492.36
520884-208842.2642.27
620670-206702.2412.25
30min127990-279903.0353.002.093.053.012.16
228102-281023.0473.06
327947-279473.0303.04
428071-280713.0433.06
527130-271302.9412.95
626759-267592.9012.91
45min137739-377394.0924.041.804.114.061.83
237724-377244.0904.11
337534-375344.0694.09
437624-376244.0794.10
536402-364023.9473.96
636337-363373.9403.96
60min147884-478845.1915.101.415.225.121.41
247017-470175.0975.12
347383-473835.1375.16
447405-474055.1405.16
546286-462865.0185.04
646238-462385.0135.04
极限155763-557636.0465.912.016.085.942.02
255478-554786.0156.05
354638-546385.9245.96
454599-545995.9195.95
553234-532345.7715.80
653171-531715.7655.80
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%
113.489312239316519310759319799330539317960.09
213.509365189366239365700.01
单位质量响应值RSD%判断
69124.3369375.560.26数据可信
供试品溶液批-0.5nacl(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119852-198522.1592.277.332.162.287.40
219048-190482.0712.07
322404-224042.4362.44
421778-217782.3682.37
519777-197772.1502.15
622606-226062.4582.46
10min175373-753738.1968.303.648.208.313.62
272583-725837.8927.90
377889-778898.4698.47
478504-785048.5368.54
574116-741168.0598.06
679707-797078.6678.67
15min1136676-13667614.86214.862.8214.8814.882.83
2131005-13100514.24514.26
3138608-13860815.07215.09
4140144-14014415.23915.26
5133205-13320514.48414.50
6140405-14040515.26715.29
20min1194248-19424821.12221.062.3021.1621.102.32
2187169-18716920.35220.39
3196496-19649621.36621.41
4197469-19746921.47221.52
5189146-18914620.56720.61
6197367-19736721.46121.51
30min1295102-29510232.08831.921.8132.1732.001.81
2285845-28584531.08231.16
3298484-29848432.45632.54
4298032-29803232.40732.49
5288127-28812731.33031.41
6295887-29588732.17432.25
45min1421137-42113745.79345.471.5645.9245.601.56
2408130-40813044.37944.50
3424887-42488746.20146.33
4422228-42222845.91246.05
5412283-41228344.83044.96
6420405-42040545.71445.85
60min1519113-51911356.44756.081.4656.6556.291.46
2503773-50377354.77954.98
3524355-52435557.01757.23
4520828-52082856.63356.84
5510439-51043955.50455.71
6516200-51620056.13056.34
极限1599982-59998265.24064.911.4265.5465.211.42
2581622-58162263.24463.54
3606136-60613665.90966.21
4601566-60156665.41265.72
5594456-59445664.63964.93
6598067-59806765.03265.34
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