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%
111.541712401712071711741712031713091712270.04
211.541718841723151721000.18
单位质量响应值RSD%判断
14837.6914913.340.36数据可信
中间条件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%
5min1146452-14645284.30274.8419.9884.3074.8419.98
2146482-14648284.32084.32
3132705-13270576.38976.39
4141500-14150081.45281.45
578347-7834745.09945.10
6134625-13462577.49477.49
10min1163333-16333394.02094.663.6594.4995.083.69
2168610-16861097.05797.53
3160921-16092192.63193.06
4163448-16344894.08694.54
5156606-15660690.14790.40
6173731-173731100.005100.44
15min1166703-16670395.95998.312.8296.9599.252.80
2172095-17209599.063100.07
3166772-16677295.99996.94
4168123-16812396.77797.75
5171657-17165798.81199.56
6179355-179355103.242104.23
20min1166453-16645395.81698.312.1297.3499.802.11
2171586-17158698.770100.33
3173152-17315299.672101.14
4167379-16737996.34997.86
5170082-17008297.90599.20
6176092-176092101.364102.92
30min1168186-16818696.81398.102.2998.87100.142.26
2169817-16981797.75299.86
3174633-174633100.524102.55
4164730-16473094.82496.87
5170238-17023897.99499.84
6174951-174951100.707102.83
45min1166310-16631095.73397.792.1298.33100.372.10
2168598-16859897.05099.70
3173127-17312799.657102.24
4167161-16716196.22398.80
5168680-16868097.09899.49
6175417-175417100.976103.66
60min1165958-16595895.53196.832.0198.6699.952.02
2166583-16658395.89099.08
3169577-16957797.614100.75
4166606-16660695.90499.01
5166022-16602295.56798.50
6174549-174549100.476103.72
极限1165903-16590395.49997.111.6399.16100.781.62
2170684-17068498.251101.97
3169706-16970697.688101.37
4165017-16501794.98998.63
5168910-16891097.230100.69
6172026-17202699.024102.83
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%
110.881834991835451832061831771834191833690.10
210.951838241841561839900.13
单位质量响应值RSD%判断
16853.7716802.740.22数据可信
中间条件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%
5min1101152-10115253.96251.575.8253.9651.565.82
295016-9501650.68950.69
391993-9199349.07649.08
490126-9012648.08048.08
596601-9660151.53551.53
6105068-10506856.05256.05
10min1158728-15872884.67884.944.0084.9885.234.00
2158648-15864884.63584.92
3162147-16214786.50286.77
4150377-15037780.22380.49
5155990-15599083.21783.50
6169442-16944290.39490.71
15min1171593-17159391.54192.472.4192.3193.232.43
2173122-17312292.35793.11
3171173-17117391.31792.07
4169316-16931690.32791.04
5173506-17350692.56293.31
6181288-18128896.71397.53
20min1174702-17470293.20094.191.9394.4895.461.95
2177117-17711794.48895.75
3176803-17680394.32195.58
4173438-17343892.52693.74
5174401-17440193.03994.30
6182852-18285297.54898.90
30min1178042-17804294.98294.641.2696.7896.441.29
2177589-17758994.74096.53
3177723-17772394.81196.60
4173611-17361192.61894.35
5176972-17697294.41196.19
6180509-18050996.29898.19
45min1176227-17622794.01394.471.1296.3496.791.15
2175934-17593493.85796.17
3177817-17781794.86297.17
4175960-17596093.87196.11
5175749-17574993.75896.06
6180817-18081796.46298.89
60min1175556-17555693.65593.531.4396.5096.371.45
2175530-17553093.64296.48
3173962-17396292.80595.64
4174399-17439993.03895.80
5172569-17256992.06294.89
6179885-17988595.96598.93
极限1176556-17655694.18994.071.4897.5697.431.48
2178258-17825895.09798.45
3172887-17288792.23295.59
4173693-17369392.66295.94
5176913-17691394.37997.72
6179650-17965095.84099.34
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%
111.541723781722531721261721311720851721950.07
211.541709701713931711820.18
单位质量响应值RSD%判断
14921.5814833.800.42数据可信
中间条件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%
5min1136173-13617378.37487.446.1178.3787.446.11
2160623-16062392.44692.45
3150716-15071686.74486.74
4154924-15492489.16689.17
5160948-16094892.63392.63
6148186-14818685.28885.29
10min1170524-17052498.14599.922.0098.58100.412.01
2175235-175235100.856101.37
3168317-16831796.87597.36
4177448-177448102.130102.63
5174443-174443100.400100.92
6175731-175731101.142101.62
15min1173841-173841100.054100.621.59101.03101.661.58
2174622-174622100.504101.58
3174227-174227100.276101.30
4170956-17095698.39499.46
5179415-179415103.262104.33
6175888-175888101.232102.27
20min1173104-17310499.630100.421.11101.17102.021.11
2176821-176821101.769103.40
3171707-17170798.826100.40
4176255-176255101.443103.05
5174059-174059100.179101.83
6174915-174915100.672102.27
30min1172478-17247899.270100.141.68101.36102.301.66
2177739-177739102.297104.50
3171721-17172198.834100.96
4177647-177647102.245104.42
5171562-17156298.742100.94
6172777-17277799.442101.60
45min1171694-17169498.81899.851.45101.46102.561.42
2175298-175298100.893103.66
3174786-174786100.598103.27
4174187-174187100.253102.99
5169246-16924697.409100.16
6175674-175674101.109103.82
60min1169480-16948097.54499.221.32100.73102.491.31
2174976-174976100.707104.03
3171642-17164298.788102.02
4174452-174452100.406103.70
5170299-17029998.015101.31
6173545-17354599.884103.16
极限1168978-16897897.25597.741.32100.99101.561.31
2172838-17283899.477103.36
3167122-16712296.18799.97
4171676-17167698.808102.66
5167803-16780396.579100.42
6170471-17047198.114101.94
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%
110.881842151843371843291840751842371842390.06
210.951831711834121832920.10
单位质量响应值RSD%判断
16933.7316739.000.82数据可信
中间条件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%
5min180141-8014142.73454.8217.8042.7354.8217.80
299548-9954853.08353.08
3110438-11043858.89058.89
4121589-12158964.83664.84
5121791-12179164.94464.94
683352-8335244.44744.45
10min1157430-15743083.94885.994.4584.1986.294.49
2161578-16157886.16086.45
3164573-16457387.75788.08
4168069-16806989.62189.98
5166966-16696689.03389.39
6148918-14891879.40979.66
15min1172970-17297092.23492.802.8292.9493.582.85
2172418-17241891.94092.71
3178515-17851595.19196.01
4171016-17101691.19292.05
5181200-18120096.62397.48
6168046-16804689.60990.30
20min1175984-17598493.84194.560.7395.0695.850.78
2177531-17753194.66695.95
3179619-17961995.78097.12
4176890-17689094.32595.69
5177586-17758694.69696.09
6176331-17633194.02795.21
30min1178969-17896995.43395.770.6097.1797.590.62
2180694-18069496.35398.16
3180830-18083096.42698.30
4180105-18010596.03997.93
5178383-17838395.12197.04
6178635-17863595.25596.96
45min1177431-17743194.61395.892.0296.8898.251.98
2178042-17804294.93997.28
3186397-18639799.394101.81
4177847-17784794.83597.26
5177454-17745494.62597.07
6181818-18181896.95299.19
60min1173945-17394592.75494.781.5095.5597.671.46
2178248-17824895.04997.92
3180266-18026696.12599.09
4177805-17780594.81397.76
5175428-17542893.54596.52
6180743-18074396.37999.16
极限1174097-17409792.83593.430.8096.1496.840.75
2175703-17570393.69297.09
3176057-17605793.88097.38
4174436-17443693.01696.49
5173615-17361592.57896.07
6177314-17731494.55197.86
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%
111.541726881728551727401726811725161726960.08
211.541723061728341725700.22
单位质量响应值RSD%判断
14964.9914954.070.06数据可信
中间条件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%
5min1111920-11192064.06278.7512.6164.0678.7512.61
2141492-14149280.98980.99
3149213-14921385.40985.41
4151417-15141786.67086.67
5151428-15142886.67786.68
6119971-11997168.67168.67
10min1172230-17223098.58494.393.5298.9494.833.50
2161052-16105292.18592.64
3165826-16582694.91895.39
4167056-16705695.62296.10
5167643-16764395.95896.44
6155621-15562189.07789.46
15min1173485-17348599.30296.152.34100.2197.112.30
2162725-16272593.14394.11
3164661-16466194.25195.25
4168301-16830196.33597.35
5170779-17077997.75398.77
6167907-16790796.10996.99
20min1176914-176914101.26596.973.07102.7298.463.00
2162133-16213392.80494.28
3167144-16714495.67297.20
4166709-16670995.42396.97
5170795-17079597.76299.32
6172738-17273898.874100.28
30min1173137-17313799.10396.242.19101.1298.272.14
2162966-16296693.28195.28
3165758-16575894.87996.94
4167735-16773596.01198.09
5167853-16785396.07898.18
6171318-17131898.062100.02
45min1172449-17244998.70996.392.77101.2898.962.73
2164207-16420793.99196.50
3163237-16323793.43696.02
4168110-16811096.22598.84
5175192-175192100.279102.91
6167147-16714795.67498.18
60min1172418-17241898.69194.502.78101.8197.612.72
2158382-15838290.65793.69
3165991-16599195.01298.12
4163175-16317593.40196.55
5166204-16620495.13498.33
6164451-16445194.13197.17
极限1170585-17058597.64295.152.38101.3198.782.32
2161618-16161892.50996.05
3161743-16174392.58196.21
4165243-16524394.58498.25
5168721-16872196.575100.30
6169432-16943296.982100.54
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%
110.881848851851311852591854521853231852100.12
210.951840221847221843720.27
单位质量响应值RSD%判断
17022.9816837.630.78数据可信
中间条件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%
5min157133-5713330.29652.3323.0330.3052.3423.03
2111314-11131459.02759.03
394732-9473250.23450.23
4106864-10686456.66856.67
5123463-12346365.47065.47
698643-9864352.30852.31
10min1143614-14361476.15584.175.6176.3284.465.67
2161767-16176785.78286.11
3152344-15234480.78581.06
4163159-16315986.52086.83
5165279-16527987.64488.01
6166163-16616388.11388.40
15min1164654-16465487.31291.122.8587.9091.882.91
2171001-17100190.67891.48
3167723-16772388.94089.67
4176298-17629893.48794.28
5175189-17518992.89993.75
6176192-17619293.43194.21
20min1174835-17483592.71193.191.2693.7994.451.27
2171838-17183891.12292.43
3176479-17647993.58394.80
4175916-17591693.28494.60
5177212-17721293.97295.34
6178126-17812694.45695.76
30min1177771-17777194.26893.750.9395.8695.540.88
2174000-17400092.26894.08
3177366-17736694.05395.80
4178105-17810594.44596.28
5175637-17563793.13695.03
6177941-17794194.35896.18
45min1179234-17923495.04494.112.2997.1696.412.25
2174291-17429192.42394.75
3175387-17538793.00495.27
4178548-17854894.68097.04
5184193-18419397.674100.08
6173156-17315691.82194.17
60min1177087-17708793.90592.251.9496.5595.081.83
2168627-16862789.41992.26
3178041-17804194.41197.19
4173838-17383892.18295.07
5173632-17363292.07395.02
6172608-17260891.53094.39
极限1176615-17661593.65592.700.9796.8296.040.94
2172277-17227791.35594.69
3173378-17337891.93995.24
4174702-17470292.64196.04
5176034-17603493.34796.81
6175837-17583793.24396.61
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