瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.541753661738241746991755151748571748520.39
211.541750881749801750340.05
单位质量响应值RSD%判断
15151.8215167.590.08数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-pH2.0(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178298-7829844.22653.179.3244.2353.179.32
296542-9654254.53154.53
390934-9093451.36351.36
4101099-10109957.10457.10
5102326-10232657.79857.80
695632-9563254.01754.02
10min1131852-13185274.47576.893.3974.7277.183.40
2135508-13550876.54076.84
3131196-13119674.10474.39
4138655-13865578.31778.63
5143653-14365381.14181.46
6135869-13586976.74477.04
15min1154542-15454287.29187.923.0487.9588.643.05
2151787-15178785.73586.46
3150282-15028284.88585.58
4160421-16042190.61291.36
5162224-16222491.63092.40
6154690-15469087.37588.10
20min1160019-16001990.38591.883.3791.5393.093.37
2159157-15915789.89891.10
3156305-15630588.28789.46
4168720-16872095.29996.56
5169900-16990095.96697.25
6161845-16184591.41692.63
30min1167703-16770394.72595.643.1596.3797.363.16
2163607-16360792.41194.12
3164985-16498593.19094.85
4175212-17521298.966100.75
5176486-17648699.686101.50
6167915-16791594.84596.56
45min1175482-17548299.11997.712.85101.2999.962.84
2167771-16777194.76396.98
3166576-16657694.08896.27
4176962-17696299.955102.29
5178492-178492100.819103.19
6172651-17265197.52099.77
60min1169608-16960895.80196.572.9798.5299.362.97
2166840-16684094.23796.98
3165739-16573993.61696.32
4174535-17453598.584101.47
5179232-179232101.237104.16
6169828-16982895.92598.71
极限1165995-16599593.76095.782.4197.0299.112.44
2166684-16668494.14997.42
3165693-16569393.59096.81
4173409-17340997.948101.39
5175208-17520898.964102.45
6170391-17039196.24399.56
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.881852531845051850471848871857591850900.26
210.951856111848101852100.31
单位质量响应值RSD%判断
17011.9516914.160.41数据可信
供试品溶液-CLB05410批-依折麦布-pH2.0(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156667-5666729.99130.9015.5029.9930.9015.51
260089-6008931.80231.80
341066-4106621.73421.73
462841-6284133.25833.26
564522-6452234.14834.15
665174-6517434.49334.49
10min1133203-13320370.49777.647.2270.6677.817.22
2150978-15097879.90480.08
3142964-14296475.66375.78
4137962-13796273.01573.20
5161677-16167785.56685.76
6153376-15337681.17381.36
15min1174033-17403392.10696.513.5692.6697.123.58
2183335-18333597.02997.65
3179885-17988595.20395.74
4178114-17811494.26694.86
5192219-192219101.731102.40
6186594-18659498.75499.40
20min1181707-18170796.16799.042.4597.24100.182.49
2186276-18627698.58599.74
3183424-18342497.07698.15
4186389-18638998.64599.76
5193557-193557102.439103.67
6191515-191515101.358102.55
30min1184883-18488397.84899.671.8599.45101.361.87
2184761-18476197.78399.49
3186422-18642298.663100.27
4190671-190671100.911102.57
5193167-193167102.232104.03
6190087-190087100.602102.36
45min1190793-190793100.976100.721.76103.12102.961.79
2187164-18716499.055101.31
3186499-18649998.703100.86
4189028-189028100.042102.26
5194381-194381102.875105.24
6193938-193938102.640104.95
60min1186721-18672198.82199.942.14101.53102.742.16
2186803-18680398.864101.67
3184717-18471797.760100.47
4187157-18715799.052101.83
5195069-195069103.239106.18
6192538-192538101.899104.78
极限1182680-18268096.68299.692.2199.94103.042.24
2187267-18726799.110102.46
3185727-18572798.295101.54
4188196-18819699.601102.93
5193642-193642102.484106.00
6192628-192628101.947105.40
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.541755861757541761621753671758921757520.18
211.541775741777651776700.08
单位质量响应值RSD%判断
15229.8115396.010.77数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131099-13109973.31167.688.3673.3167.688.36
2124377-12437769.55269.55
3131394-13139473.47673.48
4115044-11504464.33364.33
5119171-11917166.64166.64
6105143-10514358.79658.80
10min1163856-16385691.62990.261.1592.0490.641.18
2160927-16092789.99190.38
3163349-16334991.34591.75
4161029-16102990.04890.41
5160320-16032089.65190.02
6159000-15900088.91389.24
15min1171582-17158295.94995.051.9596.8795.931.94
2170564-17056495.38096.27
3172739-17273996.59697.51
4170399-17039995.28796.15
5163452-16345291.40392.27
6171090-17109095.67496.49
20min1172116-17211696.24896.681.0297.7098.091.02
2173215-17321596.86298.28
3175545-17554598.16599.62
4170880-17088095.55696.94
5171482-17148295.89397.27
6174123-17412397.37098.72
30min1170963-17096395.60397.081.1097.5999.021.07
2174335-17433597.48999.44
3174737-17473797.71399.71
4175415-17541598.092100.01
5171434-17143495.86697.78
6174694-17469497.68999.58
45min1171593-17159395.95596.680.8798.4799.160.85
2173511-17351197.02899.52
3173192-17319296.84999.39
4172815-17281596.63999.10
5170974-17097495.60998.05
6175213-17521397.979100.42
60min1175505-17550598.14396.551.32101.1999.571.30
2170625-17062595.41498.45
3175178-17517897.960101.04
4170134-17013495.13998.14
5171811-17181196.07799.05
6172717-17271796.58499.56
极限1169556-16955694.81695.391.0698.4198.941.03
2170591-17059195.39598.96
3171405-17140595.85099.47
4172673-17267396.559100.09
5167600-16760093.72297.23
6171665-17166595.99599.51
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.881857931864421860301868061864661863070.22
210.951874741889251882000.55
单位质量响应值RSD%判断
17123.8117187.210.27数据可信
供试品溶液-CLB05410批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159666-5966631.22331.898.4831.2231.898.49
258179-5817930.44530.45
358636-5863630.68430.68
455643-5564329.11829.12
570163-7016336.71736.72
663348-6334833.15033.15
10min1159301-15930183.36379.346.2083.5479.526.20
2139909-13990973.21573.38
3158170-15817082.77182.94
4140008-14000873.26773.43
5159789-15978983.61883.82
6152496-15249679.80279.99
15min1184594-18459496.59994.172.1897.2494.792.18
2175018-17501891.58792.16
3184038-18403896.30896.94
4178311-17831193.31193.88
5176769-17676992.50493.17
6181011-18101194.72495.35
20min1186051-18605197.36197.301.0198.5398.441.02
2184383-18438396.48897.57
3188753-18875398.77599.94
4184098-18409896.33997.43
5184824-18482496.71997.90
6187468-18746898.10399.26
30min1184443-18444396.52097.441.0898.2399.131.04
2185129-18512996.87998.50
3187306-18730698.01899.73
4188892-18889298.848100.47
5183900-18390096.23597.96
6187591-18759198.16799.87
45min1185470-18547097.05796.831.0899.3199.051.06
2183862-18386296.21698.37
3185178-18517896.90499.16
4186176-18617697.42699.60
5181857-18185795.16697.42
6187673-18767398.210100.45
60min1189814-18981499.33096.531.82102.1299.301.80
2180684-18068494.55297.25
3187145-18714597.934100.73
4183206-18320695.87298.59
5183252-18325295.89698.68
6182722-18272295.61998.41
极限1182432-18243295.46795.251.4198.8198.541.36
2179980-17998094.18497.40
3182476-18247695.49098.83
4186181-18618197.429100.67
5178711-17871193.52096.84
6182272-18227295.38398.70
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.541763311771951760641773551779281769750.44
211.541744011757121750560.53
单位质量响应值RSD%判断
15335.7915169.500.78数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-pH6.6(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169594-16959495.21286.8011.3395.2186.8011.33
2154472-15447286.72286.72
3120926-12092667.88967.89
4155609-15560987.36187.36
5160818-16081890.28590.29
6166216-16621693.31693.32
10min1177570-17757099.69098.143.14100.2298.623.17
2180598-180598101.390101.87
3165318-16531892.81293.19
4178290-178290100.094100.58
5174945-17494598.21698.72
6172113-17211396.62697.14
15min1171555-17155596.31395.634.6597.4096.664.66
2175453-17545398.50199.55
3157630-15763088.49589.39
4164673-16467392.44993.49
5173204-17320497.23998.29
6179484-179484100.764101.82
20min1161280-16128090.54596.483.1292.1698.043.05
2172780-17278097.00198.59
3173456-17345697.38098.76
4175303-17530398.41799.97
5172464-17246496.82398.41
6175817-17581798.706100.32
30min1166101-16610193.25197.022.4595.3799.122.40
2172284-17228496.72298.85
3171995-17199596.56098.49
4179287-179287100.654102.76
5173692-17369297.51399.64
6173536-17353697.42599.59
45min1171624-17162496.35296.391.6998.9999.031.68
2170237-17023795.57398.24
3169139-16913994.95797.42
4177167-17716799.464102.12
5169932-16993295.40298.07
6172103-17210396.62199.33
60min1166553-16655393.50594.901.5196.6898.061.52
2168001-16800194.31897.52
3166943-16694393.72496.71
4172816-17281697.021100.23
5168374-16837494.52797.72
6171507-17150796.28699.53
极限1156952-15695288.11593.633.6591.8197.333.52
2162278-16227891.10594.83
3168975-16897594.86598.37
4172051-17205196.591100.34
5167767-16776794.18697.91
6172657-17265796.932100.71
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.881872441871591874841874041876291873840.11
210.951855831855641855740.01
单位质量响应值RSD%判断
17222.7916947.401.14数据可信
供试品溶液-CLB05410批-依折麦布-pH6.6(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177253-7725340.59633.2211.7040.6033.2211.71
265744-6574434.54834.55
359800-5980031.42431.42
457993-5799330.47530.47
559092-5909231.05231.05
659474-5947431.25331.25
10min1153958-15395880.90479.073.8881.1379.253.88
2157389-15738982.70782.90
3151171-15117179.43979.61
4152761-15276180.27580.44
5146366-14636676.91477.09
6141118-14111874.15674.33
15min1178270-17827093.67992.944.3994.3593.564.37
2184085-18408596.73597.39
3164777-16477786.58987.20
4170367-17036789.52790.14
5179660-17966094.41095.01
6183969-18396996.67497.26
20min1171885-17188590.32496.183.2491.5297.323.18
2184987-18498797.20998.40
3183805-18380596.58897.69
4184896-18489697.16198.27
5183007-18300796.16997.29
6189641-18964199.655100.78
30min1178671-17867193.89097.242.1595.5998.912.11
2185140-18514097.29099.02
3182515-18251595.91097.54
4189884-18988499.783101.43
5186446-18644697.97699.63
6187615-18761598.590100.27
45min1183810-18381096.59196.391.5298.8198.601.50
2183394-18339496.37298.64
3178822-17882293.97096.14
4187053-18705398.295100.50
5182299-18229995.79798.00
6185163-18516397.30299.53
60min1178473-17847393.78695.171.6696.5497.921.63
2180557-18055794.88197.69
3177744-17774493.40396.09
4182694-18269496.00498.76
5181205-18120595.22297.96
6185989-18598997.736100.50
极限1168727-16872788.66593.493.2191.9496.763.10
2174001-17400191.43694.77
3178866-17886693.99397.20
4181407-18140795.32898.61
5179647-17964794.40397.67
6184766-18476697.093100.40
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2025-11-12 14:06:00 完成)
生成报告数据部分(等待生成报告)
Current page cost:72 ms