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%
19.868339583326834498343783376833970.06
29.958324583230832380.02
单位质量响应值RSD%判断
8458.118365.630.78数据可信
供试品溶液-2024110221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%
5min189371-8937195.43198.672.2995.4398.672.29
290397-9039796.52796.53
392357-9235798.62098.62
493709-93709100.063100.06
594032-94032100.408100.41
694562-94562100.974100.97
10min192420-9242098.687100.381.3598.85100.541.35
292867-9286799.16499.33
393623-9362399.971100.14
494363-94363100.762100.93
595701-95701102.190102.36
695048-95048101.493101.66
15min193031-9303199.339100.531.1599.66100.861.15
293306-9330699.63399.96
393469-9346999.807100.14
494220-94220100.609100.94
595633-95633102.118102.46
695230-95230101.687102.02
20min193423-9342399.758100.500.97100.25101.000.98
293404-9340499.738100.23
393403-9340399.737100.23
493970-93970100.342100.84
595466-95466101.939102.45
695022-95022101.465101.97
30min193237-9323799.559100.421.02100.21101.091.02
293264-9326499.588100.25
393497-9349799.837100.50
493871-93871100.236100.91
595580-95580102.061102.74
694818-94818101.248101.92
45min193327-9332799.655100.230.98100.48101.060.98
293116-9311699.430100.25
393236-9323699.558100.39
493559-9355999.903100.74
595381-95381101.849102.70
694576-94576100.989101.83
极限192725-9272599.013100.071.03100.00101.071.04
292995-9299599.301100.29
393227-9322799.549100.54
493576-9357699.921100.92
595131-95131101.582102.60
694658-94658101.077102.09
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%
113.784836848600487304818648644485060.47
213.834945149773496120.46
单位质量响应值RSD%判断
3520.033587.271.34数据可信
供试品溶液-2024110221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%
5min150605-5060589.91890.983.1689.9290.983.16
251538-5153891.57691.58
353343-5334394.78394.78
449246-4924687.50487.50
549795-4979588.47988.48
652693-5269393.62893.63
10min155223-5522398.12499.081.6998.2799.231.69
255308-5530898.27598.43
356922-56922101.143101.30
456396-56396100.208100.35
554403-5440396.66796.81
656314-56314100.062100.22
15min155590-5559098.77698.771.9499.0999.091.94
256232-5623299.917100.23
356514-56514100.418100.74
454449-5444996.74997.06
554118-5411896.16096.47
656618-56618100.603100.93
20min156142-5614299.75798.832.13100.2399.312.13
255632-5563298.85199.33
357145-57145101.539102.03
454592-5459297.00397.48
553917-5391795.80396.27
656283-56283100.007100.50
30min155438-5543898.50699.071.2499.1599.711.24
255905-5590599.33699.98
356713-56713100.771101.43
454647-5464797.10097.74
555755-5575599.06999.70
656067-5606799.624100.28
45min155704-5570498.97998.821.3399.7999.641.33
255652-5565298.88699.70
356526-56526100.439101.27
454440-5444096.73397.53
555197-5519798.07898.87
656185-5618599.833100.66
极限154945-5494597.63098.601.7898.6099.571.78
255185-5518598.05699.03
357121-57121101.496102.49
454922-5492297.58998.55
554522-5452296.87897.84
656235-5623599.922100.91
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%
19.868350183391834308327783127833450.18
29.958314683196831710.05
单位质量响应值RSD%判断
8452.848358.890.80数据可信
供试品溶液-2024110221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%
5min193618-93618100.03898.512.68100.0498.522.68
292297-9229798.62698.63
388500-8850094.56994.57
490200-9020096.38596.39
593209-9320999.60199.60
695325-95325101.862101.86
10min193623-93623100.043100.061.82100.21100.221.82
293365-9336599.76799.93
393847-93847100.282100.44
490590-9059096.80296.96
594911-94911101.419101.59
695471-95471102.018102.19
15min193768-93768100.198100.251.96100.53100.581.95
293355-9335599.757100.09
395134-95134101.658101.98
490435-9043596.63696.96
594901-94901101.409101.74
695289-95289101.823102.16
20min193442-9344299.850100.102.10100.35100.602.09
293115-9311599.500100.00
395510-95510102.059102.55
490168-9016896.35196.83
594789-94789101.289101.79
695054-95054101.572102.08
30min193156-9315699.544100.172.15100.21100.832.14
293250-9325099.644100.31
396082-96082102.671103.33
490312-9031296.50597.15
594790-94790101.290101.96
694849-94849101.353102.03
45min193044-9304499.424100.032.19100.26100.872.18
293079-9307999.462100.29
395984-95984102.566103.40
490131-9013196.31297.12
594528-94528101.010101.85
694924-94924101.433102.28
极限193138-9313899.52599.772.20100.52100.772.19
292462-9246298.80299.80
395724-95724102.288103.29
489918-8991896.08497.05
594234-94234100.696101.71
694752-94752101.249102.27
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%
113.784837249111480894831348559484890.80
213.834849348593485430.15
单位质量响应值RSD%判断
3518.803509.980.18数据可信
供试品溶液-2024110221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%
5min149576-4957689.06689.422.0589.0789.422.05
249538-4953888.99889.00
349476-4947688.88788.89
450576-5057690.86390.86
551215-5121592.01192.01
648259-4825986.70086.70
10min154478-5447897.87397.552.0198.0297.702.01
254012-5401297.03697.18
354560-5456098.02098.17
455281-5528199.31699.47
555163-5516399.10499.26
652298-5229893.95694.10
15min156465-56465101.44398.312.51101.7598.622.51
253981-5398196.98097.29
354961-5496198.74199.05
455798-55798100.244100.56
554538-5453897.98198.30
652580-5258094.46394.76
20min154448-5444897.81998.042.2398.3098.522.23
254203-5420397.37997.85
355293-5529399.33799.81
455373-5537399.48199.96
555723-55723100.110100.59
652390-5239094.12294.58
30min156422-56422101.36698.223.19102.0198.853.18
254037-5403797.08197.71
354561-5456198.02298.66
456219-56219101.001101.65
555108-5510899.00599.65
651663-5166392.81693.43
45min154113-5411397.21798.613.5098.0399.413.48
254100-5410097.19497.99
355227-5522799.219100.02
458184-58184104.531105.35
555270-5527099.296100.11
652432-5243294.19794.97
极限154463-5446397.84698.902.2298.8299.872.21
254115-5411597.22198.18
355105-5510598.99999.97
455617-5561799.919100.91
557153-57153102.679103.66
653848-5384896.74197.67
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%
19.868314483021831698299583152830960.10
29.958288082709827940.15
单位质量响应值RSD%判断
8427.598321.010.90数据可信
供试品溶液-2024110321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%
5min192906-9290699.65299.363.7199.6599.363.71
290696-9069697.28297.28
394007-94007100.833100.83
486770-8677093.07093.07
595661-95661102.607102.61
695755-95755102.708102.71
10min193772-93772100.581101.252.80100.75101.422.80
292314-9231499.01799.18
395538-95538102.475102.64
490685-9068597.27097.42
597728-97728104.824105.00
696354-96354103.350103.52
15min193777-93777100.586101.482.56100.92101.812.56
292387-9238799.09599.42
395709-95709102.659103.00
491523-9152398.16998.49
597464-97464104.541104.89
696778-96778103.805104.15
20min193805-93805100.616101.562.51101.12102.072.51
292321-9232199.02599.52
395738-95738102.690103.20
491877-9187798.54899.03
597498-97498104.577105.10
696876-96876103.910104.43
30min193520-93520100.311101.482.52100.98102.152.52
292191-9219198.88599.54
395344-95344102.267102.95
492099-9209998.78699.43
597725-97725104.821105.52
696768-96768103.794104.48
45min193480-93480100.268101.372.57101.10102.212.58
292035-9203598.71899.54
395108-95108102.014102.87
491937-9193798.61399.42
597723-97723104.819105.69
696741-96741103.765104.63
极限193053-9305399.810101.032.47100.81102.042.47
291855-9185598.52599.51
395061-95061101.963102.99
491706-9170698.36599.34
597116-97116104.168105.21
696348-96348103.344104.38
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%
113.784869448035480894795847946481440.65
213.834809247716479040.56
单位质量响应值RSD%判断
3493.763463.770.61数据可信
供试品溶液-2024110321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%
5min155025-5502599.87097.285.0699.8797.285.06
249024-4902488.97888.98
352969-5296996.13896.14
453077-5307796.33496.33
554365-5436598.67298.67
657123-57123103.677103.68
10min154559-5455999.02498.721.5699.1998.881.57
252928-5292896.06496.21
353890-5389097.81097.97
454759-5475999.38799.55
555156-55156100.107100.27
655060-5506099.933100.11
15min155464-55464100.66699.172.20101.0099.492.21
252960-5296096.12296.43
353809-5380997.66397.99
454461-5446198.84699.17
554767-5476799.40199.73
656363-56363102.298102.64
20min154957-5495799.74699.181.36100.2599.671.37
253694-5369497.45497.92
353713-5371397.48897.97
455192-55192100.173100.66
555018-5501899.857100.35
655305-55305100.378100.89
30min154610-5461099.11699.452.3799.78100.112.37
254002-5400298.01398.64
352907-5290796.02596.67
456721-56721102.948103.61
555148-55148100.093100.76
655390-55390100.532101.21
45min154451-5445198.82898.241.7699.6699.061.76
253509-5350997.11897.91
352941-5294196.08796.90
453516-5351697.13197.96
555337-55337100.436101.27
655002-5500299.828100.67
极限155258-55258100.29399.091.12101.29100.081.12
254859-5485999.568100.52
353683-5368397.43498.40
454086-5408698.16599.16
554597-5459799.093100.09
655093-5509399.993101.00
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%
19.868319483108831478334583267832120.12
29.958328683203832440.08
单位质量响应值RSD%判断
8439.358366.230.62数据可信
供试品溶液-2024110321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%
5min192685-9268599.076100.902.5699.08100.902.56
292980-9298099.39199.39
393880-93880100.353100.35
499208-99208106.048106.05
593933-93933100.410100.41
693641-93641100.098100.10
10min193830-93830100.300102.162.44100.46102.332.44
294009-94009100.491100.66
395419-95419101.998102.17
4100125-100125107.029107.21
595335-95335101.908102.08
694703-94703101.233101.40
15min193254-9325499.684102.082.59100.02102.422.58
293919-93919100.395100.73
395522-95522102.108102.45
4100227-100227107.138107.49
595059-95059101.613101.95
694973-94973101.521101.86
20min193330-9333099.765101.922.68100.26102.422.68
294182-94182100.676101.18
395330-95330101.903102.41
4100365-100365107.285107.82
594133-94133100.624101.13
694710-94710101.240101.75
30min193468-9346899.913101.782.59100.58102.462.59
293772-93772100.238100.91
395123-95123101.682102.36
4100100-100100107.002107.71
594301-94301100.803101.48
694550-94550101.069101.74
45min193318-9331899.752101.912.66100.58102.762.66
293820-93820100.289101.12
395107-95107101.665102.51
4100314-100314107.231108.12
594872-94872101.413102.26
694590-94590101.112101.95
极限193296-9329699.729101.512.59100.73102.532.59
293158-9315899.581100.58
394940-94940101.486102.50
499751-99751106.629107.70
594770-94770101.304102.32
693883-93883100.356101.37
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%
113.784807648311483294839848310482850.26
213.834857548757486660.27
单位质量响应值RSD%判断
3503.993518.870.30数据可信
供试品溶液-2024110321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%
5min153477-5347796.15696.911.2896.1696.911.28
253673-5367396.50896.51
354538-5453898.06498.06
454824-5482498.57898.58
553897-5389796.91196.91
652961-5296195.22895.23
10min155060-5506099.00299.542.0699.1699.702.06
256365-56365101.349101.51
356783-56783102.100102.26
455691-55691100.137100.30
554493-5449397.98398.14
653778-5377896.69796.86
15min155016-5501698.923100.062.2999.25100.392.29
255900-55900100.513100.84
356134-56134100.933101.27
457609-57609103.585103.92
555452-5545299.707100.03
653781-5378196.70297.02
20min155668-55668100.09599.541.35100.59100.031.35
255704-55704100.160100.66
356232-56232101.109101.61
455404-5540499.621100.12
555097-5509799.06999.56
654045-5404597.17797.66
30min156737-56737102.018100.102.49102.67100.762.48
256074-56074100.825101.49
354583-5458398.14498.81
457638-57638103.638104.31
554976-5497698.85199.51
654024-5402497.13997.78
45min155737-55737100.21999.341.94101.05100.171.93
256477-56477101.550102.38
355109-5510999.09099.92
455282-5528299.401100.24
555603-5560399.978100.80
653293-5329395.82596.63
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