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%
111.541730231740661730731735511729311733290.28
211.541724661732161728410.31
单位质量响应值RSD%判断
15019.8414977.560.20数据可信
长期18月-供试品溶液-2023122121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%
5min1139821-13982179.82482.4213.0679.8282.4213.06
2108536-10853661.96361.96
3155795-15579588.94488.94
4158926-15892690.73190.73
5155142-15514288.57188.57
6147998-14799884.49284.49
10min1166297-16629794.93996.604.0395.3897.054.07
2159263-15926390.92391.27
3174269-17426999.49099.98
4177246-177246101.190101.69
5173226-17322698.89599.39
6164893-16489394.13894.61
15min1171924-17192498.15297.822.6999.1298.822.73
2164735-16473594.04794.90
3175636-175636100.271101.32
4176654-176654100.852101.92
5171601-17160197.96799.01
6167496-16749695.62496.62
20min1167816-16781695.80697.613.4297.3299.153.43
2166536-16653695.07696.45
3177428-177428101.294102.90
4178835-178835102.097103.72
5170341-17034197.24898.83
6164915-16491594.15095.67
30min1169559-16955996.80197.071.5698.8599.151.57
2170306-17030697.22899.13
3171899-17189998.137100.30
4173924-17392499.293101.49
5166772-16677295.21097.34
6167729-16772995.75797.80
45min1165193-16519394.30995.211.3896.9097.831.45
2163930-16393093.58896.03
3168912-16891296.43299.14
4169585-16958596.81699.56
5167777-16777795.78498.44
6165262-16526294.34896.93
60min1166049-16604994.79895.861.8497.9199.011.82
2169224-16922496.61099.57
3172311-17231198.373101.62
4168825-16882596.38299.67
5167827-16782795.81399.00
6163235-16323593.19196.29
极限1160534-16053491.64996.523.6295.29100.213.55
2167282-16728295.50299.00
3169335-16933596.674100.47
4179406-179406102.423106.24
5167517-16751795.63699.36
6170364-17036497.261100.88
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%
110.881841241835921832691838211846091838830.28
210.951821351826931824140.22
单位质量响应值RSD%判断
16901.0116658.811.03数据可信
长期18月-供试品溶液-2023122121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%
5min192335-9233549.40354.8411.4949.4054.8311.49
293659-9365950.11250.11
390804-9080448.58448.58
4107581-10758157.56057.56
5118629-11862963.47263.47
6111914-11191459.87959.88
10min1160083-16008385.65186.781.5485.9387.081.56
2164259-16425987.88688.16
3158239-15823984.66584.93
4162979-16297987.20187.52
5164527-16452788.02988.38
6163015-16301587.22087.55
15min1175609-17560993.95892.960.7994.7193.740.78
2173646-17364692.90893.67
3172593-17259392.34593.08
4172293-17229392.18492.99
5173114-17311492.62393.47
6175195-17519593.73794.55
20min1174841-17484193.54794.601.0794.8295.911.03
2178529-17852995.52196.80
3179001-17900195.77397.03
4177900-17790095.18496.50
5174859-17485993.55794.91
6175764-17576494.04195.38
30min1179114-17911495.83494.871.4297.6396.701.38
2180172-18017296.40098.21
3175511-17551193.90695.69
4176277-17627794.31696.16
5173768-17376892.97394.85
6179074-17907495.81297.67
45min1173191-17319192.66593.041.3894.9995.401.36
2171180-17118091.58993.94
3173360-17336092.75595.06
4172474-17247492.28194.65
5175233-17523393.75796.15
6177950-17795095.21197.60
60min1174778-17477893.51493.641.5596.3596.511.48
2177893-17789395.18098.04
3177892-17789295.18098.00
4170619-17061991.28894.17
5174490-17449093.36096.27
6174419-17441993.32296.24
极限1169684-16968490.78894.382.5894.1597.772.51
2174991-17499193.62897.01
3176034-17603494.18697.54
4180620-18062096.639100.03
5174699-17469993.47196.90
6182353-18235397.567101.01
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%
111.541730501728711728011720621726801726930.22
211.541720151728501724320.35
单位质量响应值RSD%判断
14964.7314942.110.11数据可信
长期18月-供试品溶液-2023122221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%
5min1124222-12422271.13384.669.6971.1384.669.70
2157443-15744390.15690.16
3136701-13670178.27978.28
4151072-15107286.50886.51
5158663-15866390.85590.86
6158994-15899491.04591.04
10min1169643-16964397.14399.651.6197.54100.121.63
2171918-17191898.44598.95
3174961-174961100.188100.62
4175595-175595100.551101.03
5174567-17456799.962100.47
6177479-177479101.630102.14
15min1175193-175193100.321101.921.59101.26102.941.59
2179207-179207102.619103.67
3180168-180168103.169104.16
4177921-177921101.883102.92
5174141-17414199.718100.78
6181260-181260103.795104.87
20min1172647-17264798.863101.381.97100.35102.971.98
2178335-178335102.120103.74
3178232-178232102.061103.63
4178264-178264102.079103.68
5173119-17311999.133100.75
6181674-181674104.032105.68
30min1170023-17002397.360100.342.0899.40102.492.08
2174015-17401599.646101.83
3179157-179157102.591104.72
4174491-17449199.919102.09
5173927-17392799.596101.76
6179712-179712102.908105.13
45min1173009-17300999.070100.192.15101.65102.902.10
2171636-17163698.284101.02
3181080-181080103.692106.39
4177189-177189101.464104.19
5171388-17138898.142100.86
6175517-175517100.506103.30
60min1172383-17238398.71298.840.66101.84102.100.67
2171351-17135198.121101.41
3173124-17312499.136102.41
4172994-17299499.061102.35
5171412-17141298.156101.42
6174333-17433399.828103.18
极限1170893-17089397.85899.442.46101.54103.262.39
2170125-17012597.419101.25
3181661-181661104.024107.85
4174683-174683100.029103.87
5171289-17128998.085101.89
6173309-17330999.242103.15
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%
110.881837281834581841481829051822251832930.41
210.951834531830151832340.17
单位质量响应值RSD%判断
16846.7816733.700.48数据可信
长期18月-供试品溶液-2023122221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%
5min183756-8375644.78454.5615.4644.7854.5615.46
2111063-11106359.38459.38
389120-8912047.65247.65
4104823-10482356.04856.05
596517-9651751.60751.61
6127005-12700567.90967.91
10min1153165-15316581.89686.603.6682.1486.903.69
2162666-16266686.97687.31
3159476-15947685.27085.54
4162637-16263786.96187.27
5162390-16239086.82987.12
6171453-17145391.67492.05
15min1172875-17287592.43594.062.0893.1494.842.12
2179262-17926295.85096.66
3173718-17371892.88693.62
4173412-17341292.72293.52
5174512-17451293.31094.08
6181656-18165697.13098.02
20min1176358-17635894.29795.841.6895.5197.151.74
2182107-18210797.37198.72
3176915-17691594.59595.85
4178408-17840895.39396.70
5177892-17789295.11796.40
6183809-18380998.28199.71
30min1174966-17496693.55395.881.7095.2997.721.73
2180059-18005996.27698.16
3179483-17948395.96897.75
4176783-17678394.52496.36
5181277-18127796.92798.74
6183375-18337598.049100.02
45min1179686-17968696.07795.691.0298.3498.070.97
2175791-17579193.99496.42
3181234-18123496.90499.22
4178618-17861895.50697.87
5178768-17876895.58697.94
6179709-17970996.08998.61
60min1177665-17766594.99694.281.1097.7997.181.08
2176371-17637194.30497.25
3173782-17378292.92095.77
4174365-17436593.23296.13
5178779-17877995.59298.48
6176991-17699194.63697.69
极限1176954-17695494.61694.991.3397.9498.421.24
2175112-17511293.63197.10
3181744-18174497.177100.54
4177340-17734094.82298.24
5178793-17879395.59999.02
6176029-17602994.12197.70
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%
111.541741401738421738461741841742011740430.11
211.541738961738471738720.02
单位质量响应值RSD%判断
15081.7215066.900.07数据可信
长期18月-供试品溶液-2023122321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%
5min1123883-12388370.37079.8919.7070.3779.8919.70
293481-9348153.10153.10
3159582-15958290.64890.65
4156804-15680489.07089.07
5142935-14293581.19281.19
6167188-16718894.96994.97
10min1169655-16965596.37095.447.5396.7695.887.58
2142832-14283281.13481.43
3173344-17334498.46698.97
4172567-17256798.02498.52
5171682-17168297.52297.97
6178000-178000101.111101.64
15min1176354-176354100.17697.735.17101.1098.705.23
2155355-15535588.24788.99
3173014-17301498.27899.33
4171927-17192797.66198.70
5173961-17396198.81699.81
6181673-181673103.197104.29
20min1177643-177643100.90898.623.76102.39100.143.82
2163683-16368392.97894.21
3173312-17331298.448100.04
4169385-16938596.21797.80
5175352-17535299.606101.15
6182371-182371103.593105.26
30min1178583-178583101.44298.862.68103.49100.932.74
2166741-16674194.71596.47
3176373-176373100.186102.33
4169771-16977196.43698.55
5176395-176395100.199102.29
6176408-176408100.206102.44
45min1176616-176616100.32497.982.38102.93100.602.44
2167636-16763695.22397.50
3172557-17255798.019100.72
4170657-17065796.93999.59
5169460-16946096.26098.91
6178029-178029101.127103.92
60min1171272-17127297.28996.662.27100.4599.812.38
2163785-16378593.03695.84
3170392-17039296.789100.03
4168919-16891995.95299.14
5170893-17089397.074100.26
6175678-17567899.792103.15
极限1171720-17172097.54396.201.35101.2599.901.44
2165949-16594994.26597.59
3168047-16804795.45799.24
4168297-16829795.59999.32
5171428-17142897.377101.10
6170703-17070396.966100.88
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%
110.881841031854391854141857491861431853700.42
210.951865861860721863290.20
单位质量响应值RSD%判断
17037.6817016.350.09数据可信
长期18月-供试品溶液-2023122321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%
5min191273-9127348.12456.5022.3048.1256.5022.30
2102890-10289054.24954.25
3119009-11900962.74862.75
4122666-12266664.67664.68
570546-7054637.19537.20
6136515-13651571.97871.98
10min1160211-16021184.47185.367.3084.7485.687.35
2168552-16855288.86989.17
3168010-16801088.58388.93
4165930-16593087.48787.85
5138803-13880373.18473.39
6169908-16990889.58489.98
15min1176000-17600092.79691.912.9993.5392.693.06
2175806-17580692.69493.49
3175451-17545192.50793.35
4173649-17364991.55792.40
5164663-16466386.81987.43
6180292-18029295.05995.96
20min1180056-18005694.93594.091.8496.1995.391.91
2176819-17681993.22894.54
3179890-17989094.84796.20
4176907-17690793.27494.63
5173868-17386891.67292.77
6183230-18323096.60898.03
30min1182921-18292196.44595.101.4098.2296.921.29
2178681-17868194.21096.04
3182026-18202695.97397.85
4177453-17745393.56295.43
5182930-18293096.45098.05
6178256-17825693.98695.95
45min1178228-17822893.97194.180.6796.2996.540.74
2179103-17910394.43296.78
3180651-18065195.24897.66
4178384-17838494.05396.45
5177044-17704493.34795.49
6178388-17838894.05596.54
60min1174087-17408791.78792.850.8094.6295.720.77
2174714-17471492.11894.99
3176639-17663993.13396.08
4176823-17682393.23096.14
5177790-17779093.74096.40
6176571-17657193.09796.10
极限1173771-17377191.62192.381.2294.9795.771.09
2175980-17598092.78696.17
3173771-17377191.62195.08
4176968-17696893.30696.74
5178111-17811193.90997.09
6172701-17270191.05794.58
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-11-12 14:13:00 完成)
生成报告数据部分(等待生成报告)
Current page cost:51 ms