氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.089489195108950599491094748949430.16
215.059528395099951910.14
单位质量响应值RSD%判断
6295.956324.980.33数据可信
中间条件6月-供试品溶液-2025021521批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141471-4147142.60245.9410.6742.6045.9410.67
243151-4315144.32844.33
349917-4991751.27851.28
450603-5060351.98351.98
544721-4472145.94045.94
638462-3846239.51139.51
10min177511-7751179.62582.032.6179.7082.112.61
280741-8074182.94383.02
381914-8191484.14884.23
481427-8142783.64783.73
580538-8053882.73482.81
677002-7700279.10279.17
15min185463-8546387.79391.042.2288.0091.252.23
289966-8996692.41992.63
390137-9013792.59592.82
490357-9035792.82193.05
587123-8712389.49989.71
688672-8867291.09091.29
20min189739-8973992.18696.142.8592.5496.502.84
294383-9438396.95797.32
394851-9485197.43797.82
497291-9729199.944100.32
591454-9145493.94894.31
693782-9378296.33996.69
30min193302-9330295.84699.372.8896.3599.892.87
297895-97895100.564101.09
397155-9715599.804100.35
4100513-100513103.254103.80
593628-9362896.18196.70
697890-97890100.559101.07
45min194400-9440096.97499.392.3897.64100.082.38
296642-9664299.27799.97
398366-98366101.048101.76
4100295-100295103.030103.75
594387-9438796.96197.64
696412-9641299.04199.72
极限193748-9374896.30499.593.4497.13100.453.43
297334-9733499.988100.85
397287-9728799.940100.82
4102203-102203104.990105.88
592950-9295095.48596.33
698157-98157100.834101.68
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.871811371815411818171815581817141815530.15
2 11.851839361836341837850.12
单位质量响应值RSD%判断
15295.1115509.280.99数据可信
中间条件6月-供试品溶液-2025021521批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195329-9532951.23453.477.5851.2353.477.58
2100243-10024353.87553.87
3109519-10951958.86058.86
4103758-10375855.76455.76
5100679-10067954.10954.11
687420-8742046.98346.98
10min1139540-13954074.99577.593.9075.0877.683.90
2147797-14779779.43379.52
3153442-15344282.46682.56
4145489-14548978.19278.29
5140516-14051675.51975.61
6139404-13940474.92275.00
15min1159467-15946785.70488.273.1085.9188.483.10
2167986-16798690.28390.51
3171488-17148892.16592.40
4165625-16562589.01489.24
5158352-15835285.10585.32
6162473-16247387.32087.52
20min1168419-16841990.51693.463.0190.8793.833.01
2178418-17841895.89096.26
3179545-17954596.49596.88
4176507-17650794.86395.23
5167019-16701989.76390.12
6173512-17351293.25393.60
30min1174228-17422893.63896.862.9894.1497.382.98
2185101-18510199.481100.01
3184080-18408098.93399.48
4183259-18325998.49199.02
5172683-17268392.80793.31
6181977-18197797.80298.31
45min1176301-17630194.75297.712.8195.4198.392.81
2186118-186118100.028100.73
3184996-18499699.425100.14
4184594-18459499.20999.90
5174298-17429893.67594.34
6184483-18448399.14999.82
极限1176056-17605694.62098.143.2295.4498.983.22
2187296-187296100.661101.53
3185425-18542599.655100.54
4188209-188209101.152102.01
5174482-17448293.77494.59
6184114-18411498.95199.78
氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.089551895743957649541095577956020.16
215.059538895719955540.25
单位质量响应值RSD%判断
6339.666349.100.11数据可信
中间条件6月-供试品溶液-2025021521批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142837-4283743.77046.0610.3743.7746.0610.37
248335-4833549.38749.39
348465-4846549.52049.52
446029-4602947.03147.03
548198-4819849.24749.25
636621-3662137.41837.42
10min174095-7409575.70879.345.6275.7879.425.62
281081-8108182.84682.93
378418-7841880.12580.21
480219-8021981.96682.04
581433-8143383.20683.29
670642-7064272.18072.24
15min180759-8075982.51787.044.8482.7287.254.84
287762-8776289.67389.89
385675-8567587.54087.76
488440-8844090.36690.58
589025-8902590.96391.18
679444-7944481.17481.36
20min183648-8364885.46991.735.2585.8192.085.25
293578-9357895.61595.99
391648-9164893.64394.01
493508-9350895.54495.91
592368-9236894.37994.75
683891-8389185.71886.04
30min187433-8743389.33795.134.5689.8295.644.56
296732-9673298.83899.37
393270-9327095.30195.82
496404-9640498.50399.03
596409-9640998.50899.04
688349-8834990.27390.73
45min186660-8666088.54795.164.7389.1795.824.73
296385-9638598.48499.18
390890-9089092.86993.55
497338-9733899.457100.15
596990-9699099.10299.80
690507-9050792.47893.09
极限187731-8773189.64195.224.8890.4296.044.89
296970-9697099.08199.94
392439-9243994.45295.28
497446-9744699.568100.42
596691-9669198.79699.66
687863-8786389.77690.54
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.871820461825651826701825761822951824300.15
2 11.851820151823981822060.15
单位质量响应值RSD%判断
15369.0015376.030.04数据可信
中间条件6月-供试品溶液-2025021521批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min198594-9859453.08854.058.1153.0954.058.11
2107229-10722957.73857.74
3102059-10205954.95454.95
4105817-10581756.97856.98
5103622-10362255.79655.80
684944-8494445.73945.74
10min1136227-13622773.35276.866.6273.4476.956.62
2149582-14958280.54380.64
3144297-14429777.69777.79
4149653-14965380.58180.68
5149883-14988380.70580.80
6126777-12677768.26468.34
15min1151580-15158081.61986.866.2181.8387.086.21
2168613-16861390.79191.02
3163268-16326887.91288.13
4169630-16963091.33891.57
5168574-16857490.77091.00
6146238-14623878.74378.93
20min1158703-15870385.45491.605.9985.8091.965.99
2177522-17752295.58895.97
3171851-17185192.53492.90
4179292-17929296.54196.92
5177188-17718895.40895.79
6156106-15610684.05684.38
30min1164103-16410388.36294.875.8088.8595.385.80
2183755-18375598.94499.48
3177467-17746795.55896.08
4185764-185764100.026100.57
5183126-18312698.60599.14
6162882-16288287.70588.17
45min1164899-16489988.79195.415.5689.4396.085.57
2184846-18484699.531100.24
3175380-17538094.43495.12
4187186-187186100.791101.50
5184517-18451799.354100.06
6166312-16631289.55290.16
极限1166107-16610789.44195.845.2790.2396.685.27
2185152-18515299.696100.57
3177571-17757195.61496.45
4187306-187306100.856101.73
5184611-18461199.405100.27
6167245-16724590.05490.81
氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.089562195550955599559295480955600.06
215.059590096315961080.31
单位质量响应值RSD%判断
6336.876385.910.55数据可信
长期6月-供试品溶液-2025021521批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139628-3962840.38350.5012.3140.3850.5012.31
245378-4537846.24346.24
354738-5473855.78155.78
455783-5578356.84656.85
550386-5038651.34651.35
651435-5143552.41552.42
10min166884-6688468.15874.855.9068.2374.945.90
269975-6997571.30871.39
377437-7743778.91379.01
478000-7800079.48679.58
574803-7480376.22876.31
673616-7361675.01975.11
15min180526-8052682.06085.813.3082.2486.023.31
281784-8178483.34283.54
387489-8748989.15689.38
486550-8655088.19988.43
585616-8561687.24787.46
683292-8329284.87985.09
20min188204-8820489.88590.792.2190.2091.142.22
287027-8702788.68589.02
389673-8967391.38291.75
492411-9241194.17294.55
589726-8972691.43691.79
687531-8753189.19989.55
30min192111-9211193.86694.531.4994.3395.031.50
291867-9186793.61894.10
393782-9378295.56996.09
495087-9508796.89997.43
592185-9218593.94294.45
691549-9154993.29393.80
45min195583-9558397.40495.471.3298.0396.131.31
292390-9239094.15094.79
392895-9289594.66595.35
494744-9474496.54997.24
593568-9356895.35196.02
692931-9293194.70295.36
极限195247-9524797.06295.782.1897.8596.602.17
292429-9242994.19094.99
393802-9380295.58996.43
497067-9706798.91799.77
594121-9412195.91496.74
691285-9128593.02493.84
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.871837861834961833091831071820621831520.36
2 11.851832661834861833760.09
单位质量响应值RSD%判断
15429.8215474.770.21数据可信
长期6月-供试品溶液-2025021521批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176906-7690641.19751.3311.4641.2051.3411.46
290984-9098448.73848.74
3106708-10670857.16157.16
4105728-10572856.63656.64
597850-9785052.41652.42
696796-9679651.85151.85
10min1126773-12677367.90974.495.7367.9874.585.74
2138334-13833474.10274.18
3148802-14880279.71079.80
4145415-14541577.89577.99
5141129-14112975.59975.69
6133933-13393371.74571.83
15min1152018-15201881.43285.534.1281.6185.744.13
2160482-16048285.96686.17
3168424-16842490.22190.45
4164422-16442288.07788.30
5160547-16054786.00186.21
6152151-15215181.50481.71
20min1166700-16670089.29790.453.0989.6190.803.10
2171104-17110491.65692.00
3173964-17396493.18893.57
4172490-17249092.39992.77
5169288-16928890.68491.04
6159545-15954585.46485.81
30min1177993-17799395.34794.412.5395.8194.912.52
2179821-17982196.32696.83
3179060-17906095.91896.45
4177435-17743595.04895.57
5175453-17545393.98694.49
6167704-16770489.83590.32
45min1181323-18132397.13095.402.1997.7696.062.18
2181141-18114197.03397.69
3179918-17991896.37897.07
4178907-17890795.83696.52
5176148-17614894.35895.02
6171156-17115691.68492.32
极限1183275-18327598.17696.462.6698.9697.282.65
2181662-18166297.31298.14
3179984-17998496.41397.27
4185640-18564099.443100.29
5177944-17794495.32096.14
6171948-17194892.10892.90
氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.089581095832958849566095734957840.10
215.059458994565945770.02
单位质量响应值RSD%判断
6351.726284.190.76数据可信
长期6月-供试品溶液-2025021521批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153816-5381655.21949.847.4455.2249.847.44
250128-5012851.43551.44
349116-4911650.39750.40
448631-4863149.89949.90
542907-4290744.02644.03
646860-4686048.08248.08
10min177289-7728979.30475.233.0879.4075.313.09
274111-7411176.04376.13
371863-7186373.73773.82
473328-7332875.24075.32
570809-7080972.65572.73
672501-7250174.39174.47
15min188826-8882691.14286.283.0791.3786.493.08
282984-8298485.14885.36
383264-8326485.43585.64
485127-8512787.34787.56
581660-8166083.78983.98
682677-8267784.83385.04
20min193566-9356696.00690.972.7596.3891.322.75
287877-8787790.16890.52
387367-8736789.64589.99
488075-8807590.37290.73
587908-8790890.20090.53
687128-8712889.40089.75
30min197990-97990100.54593.804.16101.0894.314.15
291788-9178894.18194.69
386756-8675689.01889.52
491047-9104793.42193.93
588862-8886291.17991.66
692061-9206194.46194.96
45min197951-97951100.50595.792.59101.2196.452.59
293504-9350495.94296.60
390883-9088393.25393.90
492375-9237594.78495.44
592852-9285295.27395.91
692575-9257594.98995.64
极限196185-9618598.69394.822.3999.5695.642.39
291699-9169994.09094.91
392309-9230994.71695.52
489363-8936391.69392.51
592143-9214394.54695.34
692787-9278795.20696.02
氨氯地平阿托伐他汀钙片项目信息
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.871821571823371824181822271824201823120.07
2 11.851806811806291806550.03
单位质量响应值RSD%判断
15359.0615245.150.53数据可信
长期6月-供试品溶液-2025021521批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101886-10188655.11451.844.6455.1151.844.64
297221-9722152.59152.59
397791-9779152.89952.90
495538-9553851.68051.68
588577-8857747.91547.91
693995-9399550.84650.85
10min1143476-14347677.61275.302.0777.7075.382.07
2139695-13969575.56775.65
3139940-13994075.69975.79
4139669-13966975.55375.64
5134751-13475172.89272.97
6137684-13768474.47974.56
15min1163726-16372688.56686.391.6888.7986.611.69
2157927-15792785.42985.64
3161723-16172387.48287.70
4159565-15956586.31586.53
5156213-15621384.50284.70
6159118-15911886.07386.28
20min1173064-17306493.61791.481.4493.9991.841.45
2167344-16734490.52390.88
3171173-17117392.59492.95
4168042-16804290.90191.26
5167015-16701590.34590.69
6168085-16808590.92491.28
30min1179579-17957997.14295.031.2597.6795.531.26
2173873-17387394.05594.56
3176537-17653795.49696.01
4173966-17396694.10594.61
5174299-17429994.28594.78
6175746-17574695.06895.57
45min1181205-18120598.02196.071.2598.7196.741.26
2175981-17598195.19595.86
3178824-17882496.73397.41
4174934-17493494.62995.29
5177018-17701895.75696.41
6177628-17762896.08696.75
极限1180822-18082297.81496.121.2798.6696.951.26
2175626-17562695.00395.83
3179700-17970097.20798.04
4175152-17515294.74795.57
5176967-17696795.72996.54
6177902-17790296.23497.06
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