比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078598386078860688604986069860490.05
210.088555185612855820.06
单位质量响应值RSD%判断
8545.088490.280.46数据可信
长期3月-供试品溶液-2023101321批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194425-9442599.57397.691.9499.5797.691.93
292494-9249497.53797.54
395181-95181100.371100.37
491304-9130496.28296.28
590713-9071395.65995.66
691730-9173096.73196.73
10min194817-9481799.98798.411.76100.1598.581.76
293242-9324298.32698.49
395738-95738100.958101.13
491980-9198096.99597.16
591635-9163596.63196.79
692523-9252397.56897.73
15min194755-9475599.92198.161.86100.2598.481.86
292774-9277497.83298.16
395663-95663100.879101.21
491725-9172596.72697.05
591464-9146496.45196.77
692109-9210997.13197.45
20min194397-9439799.54497.951.76100.0498.441.76
292558-9255897.60598.09
395342-95342100.540101.04
491810-9181096.81697.30
591110-9111096.07896.56
692100-9210097.12297.61
30min194291-9429199.43297.741.86100.1098.391.86
292431-9243197.47198.12
395252-95252100.445101.12
491414-9141496.39897.04
590904-9090495.86096.50
691801-9180196.80697.45
45min193945-9394599.06797.501.8099.9098.321.80
292308-9230897.34198.16
394954-94954100.131100.97
491060-9106096.02596.83
590781-9078195.73196.53
691709-9170996.70997.52
极限193755-9375598.86797.301.7699.8698.281.76
292121-9212197.14498.12
394665-9466599.826100.83
491045-9104596.00996.97
590525-9052595.46196.42
691515-9151596.50597.47
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.715356653882537385377453734537390.22
214.695331353338533260.04
单位质量响应值RSD%判断
3653.233630.090.45数据可信
长期3月-供试品溶液-2023101321批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153874-5387493.40693.511.6893.4193.511.68
254401-5440194.32094.32
352428-5242890.89990.90
453821-5382193.31493.31
553880-5388093.41693.42
655191-5519195.68995.69
10min155369-5536995.99894.620.9596.1594.780.95
254588-5458894.64494.80
354179-5417993.93594.09
453982-5398293.59393.75
554383-5438394.28994.44
654959-5495995.28795.45
15min155621-5562196.43594.561.1096.7594.871.10
254293-5429394.13294.45
353851-5385193.36693.67
454384-5438494.29094.60
554393-5439394.30694.62
654680-5468094.80395.12
20min155524-5552496.26794.231.4596.7494.701.45
253675-5367593.06193.53
353517-5351792.78793.25
454202-5420293.97594.44
554133-5413393.85594.33
655043-5504395.43395.91
30min155287-5528795.85694.131.2196.4994.761.21
254297-5429794.13994.77
353551-5355192.84693.46
453624-5362492.97393.60
554298-5429894.14194.77
654698-5469894.83595.47
45min154994-5499495.34894.101.1796.1494.881.17
254461-5446194.42495.21
353528-5352892.80693.58
453675-5367593.06193.84
554029-5402993.67594.46
654954-5495495.27996.07
极限155204-5520495.71293.791.3396.6794.731.33
254223-5422394.01194.95
353091-5309192.04892.98
454042-5404293.69794.63
553618-5361892.96293.90
654391-5439194.30295.25
比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078557085561855768555685582855690.02
210.088622286171861960.05
单位质量响应值RSD%判断
8497.428551.190.45数据可信
长期3月-供试品溶液-2023101322批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191793-9179396.72397.650.7196.7297.650.72
292824-9282497.80997.81
393056-9305698.05398.05
491908-9190896.84496.84
593175-9317598.17998.18
693287-9328798.29798.30
10min192595-9259597.56898.791.0497.7398.951.04
293849-9384998.88999.05
394298-9429899.36299.53
492581-9258197.55397.71
594223-9422399.28399.45
694967-94967100.067100.23
15min192593-9259397.56698.650.8497.8998.980.84
293812-9381298.85099.18
394067-9406799.11999.45
492746-9274697.72798.05
594011-9401199.06099.39
694529-9452999.60699.94
20min192612-9261297.58698.550.9598.0799.040.95
293660-9366098.69099.18
394085-9408599.13899.63
492351-9235197.31197.80
593806-9380698.84499.34
694654-9465499.737100.23
30min192034-9203496.97798.251.0397.6398.901.03
293250-9325098.25898.91
393831-9383198.87099.53
492156-9215697.10597.75
593795-9379598.83299.49
694366-9436699.434100.10
45min191704-9170496.62997.921.1597.4498.741.15
293122-9312298.12398.94
393383-9338398.39899.22
491653-9165396.57597.39
593292-9329298.30299.13
694406-9440699.476100.30
极限191910-9191096.84697.830.9397.8298.810.93
293301-9330198.31299.30
393218-9321898.22499.21
491706-9170696.63197.60
593014-9301498.00999.00
693901-9390198.94499.94
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.715345953424534235342753419534300.04
214.695372553788537560.09
单位质量响应值RSD%判断
3632.223659.360.53数据可信
长期3月-供试品溶液-2023101322批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155602-5560296.29396.941.9796.2996.941.97
255448-5544896.02696.03
357823-57823100.139100.14
456217-5621797.35897.36
554534-5453494.44494.44
656243-5624397.40397.40
10min155499-5549996.11596.601.1296.2896.761.12
254960-5496095.18195.34
356820-5682098.40298.57
455704-5570496.47096.63
556045-5604597.06097.22
655655-5565596.38596.55
15min155480-5548096.08296.361.6596.4096.681.65
254866-5486695.01895.34
356956-5695698.63898.97
456047-5604797.06497.39
556070-5607097.10497.42
654425-5442594.25594.58
20min155467-5546796.05996.491.7096.5496.981.69
254750-5475094.81895.29
357212-5721299.08199.58
454868-5486895.02295.51
556401-5640197.67798.16
655603-5560396.29596.77
30min155313-5531395.79396.281.6696.4396.921.66
254340-5434094.10894.74
357163-5716398.99699.66
455387-5538795.92196.56
555856-5585696.73397.38
655501-5550196.11896.76
45min153931-5393193.39995.521.5594.2096.321.54
254714-5471494.75595.55
356529-5652997.89998.72
455205-5520595.60696.41
555346-5534695.85096.65
655209-5520995.61396.41
极限155324-5532495.81296.161.1596.7797.131.15
254808-5480894.91895.87
356602-5660298.02599.01
455090-5509095.40696.37
555884-5588496.78197.75
655452-5545296.03396.99
比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078561585664855678550985555855820.07
210.088570085676856880.02
单位质量响应值RSD%判断
8498.718500.790.02数据可信
长期3月-供试品溶液-2023101323批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192461-9246197.70799.461.9097.7199.461.90
291676-9167696.87796.88
395692-95692101.121101.12
493915-9391599.24399.24
594791-94791100.169100.17
696174-96174101.631101.63
10min193523-9352398.829100.131.6998.99100.291.69
292315-9231597.55397.71
395960-95960101.404101.57
494735-94735100.110100.28
595362-95362100.773100.94
696601-96601102.082102.25
15min193318-9331898.61399.991.7398.94100.321.73
292308-9230897.54597.87
396020-96020101.468101.81
494796-94796100.174100.51
594610-9461099.978100.31
696686-96686102.172102.51
20min193371-9337198.66999.661.8899.16100.161.87
291356-9135696.53997.03
395840-95840101.278101.78
494579-9457999.945100.44
594557-9455799.922100.42
696178-96178101.635102.14
30min193042-9304298.32199.691.8898.98100.351.88
291705-9170596.90897.56
395847-95847101.285101.96
494222-9422299.568100.23
594696-94696100.069100.74
696486-96486101.960102.64
45min192902-9290298.17399.381.8898.99100.211.88
291167-9116796.34097.15
395460-95460100.876101.72
494244-9424499.591100.42
594543-9454399.907100.74
695963-95963101.408102.26
极限193097-9309798.37999.271.7899.36100.271.78
291234-9123496.41097.38
395289-95289100.695101.71
493801-9380199.123100.12
594356-9435699.709100.71
695890-95890101.330102.35
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.715349153409534475380353697535690.33
214.695375453841537980.12
单位质量响应值RSD%判断
3641.673662.220.40数据可信
长期3月-供试品溶液-2023101323批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155879-5587996.60995.371.1096.6195.361.10
254146-5414693.61393.61
354857-5485794.84294.84
455287-5528795.58695.59
555563-5556396.06396.06
655226-5522695.48095.48
10min156934-5693498.43396.591.1698.5996.751.16
255004-5500495.09695.25
355658-5565896.22796.39
455788-5578896.45296.61
556181-5618197.13197.29
655648-5564896.21096.37
15min156707-5670798.04196.051.2498.3796.371.24
254592-5459294.38494.70
355320-5532095.64395.96
455566-5556696.06896.39
555460-5546095.88596.21
655690-5569096.28296.60
20min155412-5541295.80293.171.9096.2993.651.89
252435-5243590.65591.13
353471-5347192.44692.92
453588-5358892.64893.13
554600-5460094.39894.88
653846-5384693.09493.57
30min154386-5438694.02893.001.8194.6893.641.81
251865-5186589.66990.29
353961-5396193.29393.93
454116-5411693.56194.20
554499-5449994.22394.86
653922-5392293.22693.86
45min155261-5526195.54193.761.4996.3594.561.49
252841-5284191.35792.13
354166-5416693.64894.43
454306-5430693.89094.68
554694-5469494.56095.36
654134-5413493.59294.38
极限155919-5591996.67894.131.5697.6495.071.55
253405-5340592.33293.26
353960-5396093.29194.23
454315-5431593.90594.85
554696-5469694.56495.52
654361-5436193.98594.93
比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078618186184861698617986208861840.02
210.088606286022860420.04
单位质量响应值RSD%判断
8558.498535.910.19数据可信
长期3月-供试品溶液-2024010421批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196582-96582101.49598.501.89101.5098.501.89
293302-9330298.04898.05
394447-9444799.25299.25
492789-9278997.50997.51
593959-9395998.73998.74
691314-9131495.95995.96
10min197208-97208102.15399.131.66102.3299.291.66
294182-9418298.97399.14
394261-9426199.05699.22
493347-9334798.09698.26
594335-9433599.13499.30
692629-9262997.34197.50
15min197423-97423102.37998.991.79102.7299.321.79
293405-9340598.15798.49
394474-9447499.28099.61
493719-9371998.48798.81
593514-9351498.27198.60
692654-9265497.36897.69
20min197188-97188102.13299.051.76102.6499.551.76
293633-9363398.39698.89
394011-9401198.79499.29
494561-9456199.37299.86
594023-9402398.80699.30
692130-9213096.81797.30
30min196681-96681101.59998.881.54102.2899.541.54
293450-9345098.20498.86
393632-9363298.39599.06
494240-9424099.03499.69
594214-9421499.00799.67
692326-9232697.02397.67
45min196969-96969101.90299.071.85102.7599.891.85
293245-9324597.98998.81
395226-95226100.070100.89
494495-9449599.302100.12
593804-9380498.57699.40
691889-9188996.56497.37
极限196521-96521101.43198.091.86102.4599.081.85
293142-9314297.88098.86
393515-9351598.27299.26
492972-9297297.70298.69
592586-9258697.29698.28
691331-9133195.97796.95
比索洛尔左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
114.715408954003540245402854104540500.09
214.695410254098541000.01
单位质量响应值RSD%判断
3674.373682.780.17数据可信
长期3月-供试品溶液-2024010421批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154944-5494494.30492.242.7594.3092.242.75
254440-5444093.43993.44
351763-5176388.84588.84
452317-5231789.79589.80
553532-5353291.88191.88
655461-5546195.19295.19
10min155296-5529694.90993.092.7395.0793.252.73
254984-5498494.37394.53
354312-5431293.22093.37
451608-5160888.57988.73
553597-5359791.99292.15
655633-5563395.48795.65
15min155796-5579695.76793.712.0496.0894.022.04
254268-5426893.14493.46
354400-5440093.37193.67
453577-5357791.95892.26
553449-5344991.73892.04
656099-5609996.28796.60
20min155816-5581695.80193.722.3296.2894.192.33
254944-5494494.30494.77
354387-5438793.34893.81
452898-5289890.79391.24
553484-5348491.79892.26
656094-5609496.27896.76
30min155676-5567695.56193.742.0296.2094.362.02
254064-5406492.79493.42
353513-5351391.84892.46
453882-5388292.48293.08
554286-5428693.17593.79
656271-5627196.58297.22
45min155821-5582195.81094.581.8996.6095.361.88
254744-5474493.96194.74
356035-5603596.17796.94
454012-5401292.70593.46
553861-5386192.44693.21
656166-5616696.40297.20
极限156011-5601196.13693.232.3397.0994.162.32
254869-5486994.17695.11
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553126-5312691.18492.11
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