厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.663272432795328183288332747327930.20
213.723291232898329050.04
单位质量响应值RSD%判断
2400.662398.320.07数据可信
供试品溶液-24032502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%
5min136579-3657996.25197.532.6096.2597.532.60
236265-3626595.42495.42
336449-3644995.90995.91
438574-38574101.500101.50
537977-3797799.92999.93
636544-3654496.15896.16
10min137611-3761198.96699.502.0699.50100.042.06
237292-3729298.12798.66
336714-3671496.60697.14
438797-38797102.087102.65
538537-38537101.403101.96
637926-3792699.795100.33
15min139086-39086102.84798.643.00103.9399.732.98
237650-3765099.069100.14
335672-3567293.86494.93
437445-3744598.52999.66
538004-38004100.000101.12
637066-3706697.53298.62
20min136086-3608694.95396.953.0896.6198.593.05
236567-3656796.21997.84
335355-3535593.03094.62
437567-3756798.850100.53
538577-38577101.508103.18
636913-3691397.12998.76
30min137593-3759398.91998.462.59101.10100.642.58
237386-3738698.374100.53
335578-3557893.61795.72
438135-38135100.345102.57
538279-38279100.724102.96
637545-3754598.792100.96
45min138655-38655101.71397.563.35104.45100.293.30
237239-3723997.987100.69
335388-3538893.11795.74
437291-3729198.124100.91
537996-3799699.979102.78
635886-3588694.42797.15
60min137881-3788199.67799.812.86102.97103.072.83
238391-38391101.019104.27
336455-3645595.92499.07
438742-38742101.942105.27
539236-39236103.242106.59
636874-3687497.027100.27
极限138949-38949102.48799.892.60106.34103.722.55
237649-3764999.066102.88
336373-3637395.70999.39
438578-38578101.511105.41
537470-3747098.595102.52
638761-38761101.992105.77
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.663284032859327553271132795327920.19
213.723254832745326460.43
单位质量响应值RSD%判断
2400.592379.450.63数据可信
供试品溶液-24032502批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133683-3368388.98387.421.5588.9887.421.55
232423-3242385.65585.65
333534-3353488.59088.59
432694-3269486.37186.37
533383-3338388.19188.19
632821-3282186.70686.71
10min135106-3510692.74392.062.2593.2492.542.24
235046-3504692.58493.06
336048-3604895.23195.72
433992-3399289.80090.28
533961-3396189.71890.21
634932-3493292.28392.76
15min134667-3466791.58392.352.6892.5993.352.67
235260-3526093.15094.14
336161-3616195.53096.55
433941-3394189.66590.64
533936-3393689.65290.64
635783-3578394.53195.53
20min134777-3477791.87492.441.7793.3993.951.77
235085-3508592.68794.19
335693-3569394.29395.85
434530-3453091.22192.70
534176-3417690.28691.77
635684-3568494.27095.79
30min134866-3486692.10992.551.9094.1494.571.89
235193-3519392.97395.00
335935-3593594.93397.01
434366-3436690.78892.77
534260-3426090.50892.50
635567-3556793.96196.00
45min133576-3357688.70190.812.2491.2493.352.22
234555-3455591.28793.83
335468-3546893.69996.30
433736-3373689.12391.61
533878-3387889.49991.99
635041-3504192.57195.14
60min134066-3406689.99591.482.6893.0394.522.64
235514-3551493.82196.87
335002-3500292.46895.59
433718-3371889.07692.06
533679-3367988.97391.96
635778-3577894.51897.60
极限134135-3413590.17892.362.3693.7195.922.32
235118-3511892.77496.34
335398-3539893.51497.15
435055-3505592.60896.09
533922-3392289.61593.10
636149-3614995.49899.10
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