依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
110.951705041699891708671709571713591707350.31
211.031726101731391728740.22
单位质量响应值RSD%判断
15592.2415673.070.37数据可信
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%
5min1138010-13801075.59580.077.4675.6080.087.46
2156008-15600885.45485.45
3154121-15412184.42084.42
4156784-15678485.87985.88
5141206-14120677.34677.35
6130999-13099971.75571.75
10min1177860-17786097.42395.322.3897.8495.762.39
2177231-17723197.07997.55
3173612-17361295.09695.57
4176189-17618996.50896.98
5172507-17250794.49194.92
6166706-16670691.31491.71
15min1179815-17981598.49496.711.5999.4697.681.59
2177410-17741097.17798.19
3173441-17344195.00396.00
4179603-17960398.37899.39
5175068-17506895.89496.85
6174014-17401495.31796.22
20min1181918-18191899.64697.042.32101.1598.552.30
2181432-18143299.380100.93
3172501-17250194.48896.01
4177752-17775297.36498.92
5176766-17676696.82498.31
6172599-17259994.54195.98
30min1179856-17985698.51696.282.35100.5898.342.34
2178497-17849797.77299.88
3172009-17200994.21896.27
4178476-17847697.76199.86
5176314-17631496.57698.60
6169522-16952292.85694.82
45min1180866-18086699.07096.572.35101.6899.152.35
2180613-18061398.931101.58
3172955-17295594.73697.31
4176689-17668996.78299.43
5176271-17627196.55399.11
6170385-17038593.32995.81
60min1180398-18039898.81395.631.98101.9798.761.96
2175021-17502195.86899.07
3171481-17148193.92997.03
4175094-17509495.90899.09
5174904-17490495.80498.90
6170662-17066293.48096.48
极限1177036-17703696.97295.661.38100.6899.321.39
2176255-17625596.544100.28
3171809-17180994.10997.73
4177077-17707796.994100.71
5172712-17271294.60398.23
6173005-17300594.76498.28
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-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(%)100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%
111.061826471820271827661826021822291824540.18
211.131845891843851844870.08
单位质量响应值RSD%判断
16496.7516575.650.34数据可信
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%
5min185512-8551246.54156.2414.1846.5456.2414.18
2108894-10889459.26759.27
3117994-11799464.22064.22
4112457-11245761.20661.21
5110975-11097560.40060.40
684159-8415945.80545.80
10min1155173-15517384.45589.273.1484.7189.583.18
2166419-16641990.57690.91
3166163-16616390.43690.79
4167699-16769991.27291.61
5168219-16821991.55591.89
6160464-16046487.33587.59
15min1170472-17047292.78295.221.6193.5196.031.61
2173645-17364594.50995.34
3173875-17387594.63495.49
4177421-17742196.56497.41
5176632-17663296.13496.98
6177685-17768596.70797.45
20min1176434-17643496.02796.870.9997.2798.210.98
2179487-17948797.68899.05
3175375-17537595.45096.84
4177902-17790296.82698.21
5179063-17906397.45798.84
6179617-17961797.75999.04
30min1180128-18012898.03797.111.0699.8198.991.05
2178606-17860697.20999.11
3176437-17643796.02897.94
4180143-18014398.04599.97
5179469-17946997.67899.60
6175807-17580795.68597.51
45min1181000-18100098.51297.781.16100.83100.201.14
2182792-18279299.487101.93
3177700-17770096.71699.16
4179297-17929797.585100.05
5179972-17997297.952100.41
6177207-17720796.44798.80
60min1178756-17875697.29096.270.87100.1699.220.81
2176240-17624095.92198.91
3174782-17478295.12798.11
4175728-17572895.64298.65
5178047-17804796.90599.91
6177695-17769596.71399.60
极限1177588-17758896.65596.330.87100.0699.830.80
2175855-17585595.71199.24
3175304-17530495.41298.93
4178124-17812496.946100.49
5175933-17593395.75499.30
6179189-17918997.526100.95
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
110.951705641691881705061705251704481702460.35
211.031748331751761750040.14
单位质量响应值RSD%判断
15547.5815866.181.44数据可信
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%
5min1137416-13741674.92179.306.7074.9279.306.70
2145043-14504379.08079.08
3152591-15259183.19583.20
4152068-15206882.91082.91
5155010-15501084.51484.51
6130506-13050671.15471.15
10min1174870-17487095.34295.731.6795.7696.171.67
2177004-17700496.50596.94
3178556-17855697.35297.81
4178317-17831797.22197.68
5173631-17363194.66695.14
6171131-17113193.30393.70
15min1177038-17703896.52497.031.2397.4798.001.22
2174847-17484795.32996.30
3181128-18112898.75499.76
4178592-17859297.37198.37
5176903-17690396.45097.45
6179257-17925797.73498.65
20min1181431-18143198.91997.351.63100.4098.861.63
2176486-17648696.22397.73
3181257-18125798.824100.38
4179527-17952797.88199.42
5178704-17870497.43298.96
6173948-17394894.83996.30
30min1174289-17428995.02595.151.6197.0697.211.61
2172550-17255094.07796.12
3178068-17806897.08699.19
4177622-17762296.84298.93
5173566-17356694.63196.70
6171039-17103993.25395.24
45min1175303-17530395.57895.571.3998.1498.151.37
2172169-17216993.86996.43
3178883-17888397.530100.17
4175596-17559695.73898.36
5173098-17309894.37696.97
6176662-17666296.31998.82
60min1171813-17181393.67595.082.0796.7798.192.05
2173281-17328194.47697.56
3177025-17702596.51799.70
4180338-18033898.323101.48
5173017-17301794.33297.45
6170857-17085793.15496.19
极限1170890-17089093.17294.222.6696.7897.862.62
2169945-16994592.65796.27
3180136-18013698.213101.93
4176633-17663396.303100.00
5171206-17120693.34496.99
6168033-16803391.61495.17
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-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(%)100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%
111.061811761823721823791819991820961820040.28
211.131861471871511866490.39
单位质量响应值RSD%判断
16456.0616769.901.34数据可信
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%
5min1103726-10372656.19858.3614.6656.2058.3614.66
2118480-11848064.19264.19
3104439-10443956.58456.58
4105489-10548957.15357.15
5130500-13050070.70470.70
683651-8365145.32245.32
10min1171587-17158792.96591.372.9993.2891.693.01
2175727-17572795.20895.56
3165591-16559189.71690.03
4166562-16656290.24290.56
5170735-17073592.50392.90
6161615-16161587.56287.81
15min1177152-17715295.98096.240.6696.8197.070.65
2175954-17595495.33196.22
3178317-17831796.61197.42
4176883-17688395.83496.65
5179138-17913897.05697.96
6178331-17833196.61997.36
20min1184369-18436999.89097.891.06101.2599.261.06
2180176-18017697.61899.03
3180576-18057697.83599.18
4179646-17964697.33198.68
5180381-18038197.72999.18
6178936-17893696.94698.22
30min1175686-17568695.18696.271.1997.1098.181.17
2177161-17716195.98597.94
3179903-17990397.47099.36
4180611-18061197.85499.75
5176965-17696595.87897.87
6175750-17575095.22097.03
45min1177602-17760296.22496.210.6198.6798.660.58
2175605-17560595.14297.63
3178298-17829896.60199.04
4178749-17874996.84599.28
5177653-17765396.25198.77
6177549-17754996.19598.54
60min1173597-17359794.05495.921.8597.0398.901.79
2177814-17781496.33899.36
3177572-17757296.20799.18
4182856-18285699.070102.04
5175297-17529794.97598.03
6175168-17516894.90597.78
极限1172534-17253493.47895.021.7896.9898.541.73
2173055-17305593.76097.31
3180081-18008197.567101.07
4178144-17814496.517100.04
5175376-17537695.01898.60
6173137-17313793.80497.21
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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%
110.951747771744421749371750261754391749240.21
211.031750791752331751560.07
单位质量响应值RSD%判断
15974.7915879.960.43数据可信
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%
5min1152958-15295882.23382.305.6082.2382.305.60
2136237-13623773.24373.24
3155937-15593783.83483.83
4160085-16008586.06486.06
5156502-15650284.13884.14
6156782-15678284.28984.29
10min1176476-17647694.87795.953.1795.3396.403.18
2169672-16967291.21991.63
3179193-17919396.33796.80
4180919-18091997.26597.74
5186907-186907100.484100.95
6177658-17765895.51295.98
15min1180723-18072397.16097.151.0698.1498.141.08
2179013-17901396.24197.15
3180379-18037996.97597.98
4184055-18405598.95199.97
5181302-18130297.47198.50
6178776-17877696.11397.11
20min1175375-17537594.28594.161.9795.8195.691.98
2168946-16894690.82892.28
3174728-17472893.93795.48
4178849-17884996.15297.72
5177755-17775595.56497.13
6175166-17516694.17295.71
30min1178727-17872796.08794.901.5298.1396.951.53
2172664-17266492.82794.78
3176662-17666294.97797.04
4180051-18005196.79998.90
5176282-17628294.77296.87
6174683-17468393.91395.97
45min1174795-17479593.97393.561.9796.5596.141.98
2168007-16800790.32492.79
3175122-17512294.14996.74
4175823-17582394.52697.17
5177897-17789795.64198.27
6172500-17250092.73995.32
60min1172276-17227692.61993.782.0095.7296.882.00
2168819-16881990.76093.73
3175958-17595894.59897.71
4178774-17877496.11299.28
5176158-17615894.70697.86
6174594-17459493.86596.96
极限1170064-17006491.42993.182.3595.0596.802.33
2167429-16742990.01393.49
3176227-17622794.74398.38
4177707-17770795.53899.24
5176226-17622694.74298.42
6172307-17230792.63596.25
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-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(%)100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%
111.061856211868411866561876561905031874550.99
211.131867791886241877020.70
单位质量响应值RSD%判断
16948.9216864.510.36数据可信
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%
5min1106992-10699256.95657.879.3756.9657.879.37
295312-9531250.73850.74
3113924-11392460.64660.65
498580-9858052.47852.48
5120293-12029364.03664.04
6117161-11716162.36962.37
10min1166628-16662888.70288.964.6689.0289.284.67
2154568-15456882.28282.56
3168415-16841589.65389.99
4165024-16502487.84888.14
5178659-17865995.10795.46
6169375-16937590.16490.51
15min1177656-17765694.57394.391.2095.3895.201.22
2175060-17506093.19193.93
3176198-17619893.79794.63
4177576-17757694.53095.31
5181142-18114296.42897.31
6176221-17622193.80994.66
20min1175771-17577193.56993.221.1394.9094.561.16
2172279-17227991.71092.97
3173765-17376592.50193.86
4175008-17500893.16394.47
5178040-17804094.77796.20
6175832-17583293.60294.97
30min1181248-18124896.48595.010.9398.3496.870.90
2178047-17804794.78196.55
3178568-17856895.05896.93
4179103-17910395.34397.17
5177546-17754694.51496.46
6176359-17635993.88295.77
45min1177477-17747794.47794.001.3396.8796.381.34
2175415-17541593.38095.67
3176920-17692094.18196.58
4173919-17391992.58394.94
5180580-18058096.12998.60
6175130-17513093.22895.64
60min1174784-17478493.04494.280.8395.9697.190.82
2176210-17621093.80396.61
3178139-17813994.83097.75
4178930-17893095.25198.12
5177424-17742494.44997.45
6177202-17720294.33197.26
极限1173067-17306792.13093.851.3795.5697.281.36
2175099-17509993.21296.54
3178764-17876495.16398.61
4176717-17671794.07397.47
5179270-17927095.43298.96
6174882-17488293.09696.55
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