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%
113.463264232701328013270832724327150.18
213.583261032685326480.17
单位质量响应值RSD%判断
2430.532404.120.78数据可信
供试品溶液-24032001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%
5min134224-3422489.39288.223.9589.3988.223.95
232284-3228484.32584.32
335166-3516691.85291.85
432936-3293686.02886.03
532658-3265885.30285.30
635378-3537892.40692.41
10min137120-3712096.95697.692.3897.4598.182.38
236131-3613194.37394.84
337972-3797299.18299.69
438511-38511100.589101.07
536752-3675295.99596.47
637918-3791899.04199.55
15min137179-3717997.11097.651.8298.1598.681.82
236474-3647495.26996.26
337892-3789298.973100.03
438385-38385100.260101.30
536981-3698196.59397.60
637395-3739597.67598.74
20min137568-3756898.12698.001.3099.7099.571.31
237164-3716497.07198.59
337957-3795799.142100.75
438075-3807599.451101.04
536776-3677696.05897.60
637576-3757698.14799.75
30min137881-3788198.94497.752.17101.0699.872.16
236439-3643995.17797.24
337608-3760898.231100.39
438479-38479100.506102.65
536477-3647795.27797.35
637667-3766798.385100.54
45min136397-3639795.06896.261.6697.7498.921.65
236539-3653995.43998.03
337131-3713196.98599.69
437778-3777898.675101.38
536126-3612694.36096.97
637152-3715297.04099.74
60min136801-3680196.12395.551.5599.3298.751.56
235822-3582293.56696.69
336987-3698796.60999.86
437102-3710296.909100.16
535910-3591093.79696.93
636874-3687496.31499.55
极限136902-3690296.38795.592.57100.1299.312.54
235297-3529792.19595.83
337087-3708796.870100.65
437785-3778598.693102.48
535640-3564093.09196.74
636862-3686296.282100.05
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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.952072916207288020737112074144207412220735550.04
215.052069677206617320679250.12
单位质量响应值RSD%判断
138699.33137403.650.67数据可信
供试品溶液-24032001批-厄贝沙坦-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%
5min1247811-24781110.77110.832.7310.7710.832.75
2240031-24003110.43210.43
3248984-24898410.82210.82
4247235-24723510.74610.75
5261083-26108311.34711.35
6249584-24958410.84810.85
10min1511995-51199522.25322.211.2222.3122.271.22
2499700-49970021.71821.78
3508820-50882022.11522.17
4512329-51232922.26722.33
5515477-51547722.40422.47
6517198-51719822.47922.54
15min1674790-67479029.32829.410.5529.5129.590.56
2675350-67535029.35329.53
3680404-68040429.57229.76
4670682-67068229.15029.33
5680046-68004629.55729.74
6678355-67835529.48329.67
20min1805313-80531335.00134.810.8135.3535.160.81
2798308-79830834.69735.04
3805537-80553735.01135.36
4790829-79082934.37234.72
5797503-79750334.66235.01
6807799-80779935.10935.46
30min1994695-99469543.23242.810.8143.7743.350.79
2989799-98979943.02043.55
3981266-98126642.64943.19
4981130-98113042.64343.18
5972853-97285342.28342.83
6989607-98960743.01143.56
45min11140487-114048749.56949.981.5550.3550.761.53
21182280-118228051.38552.16
31142903-114290349.67450.45
41139489-113948949.52650.30
51135644-113564449.35850.14
61159135-115913550.37951.16
60min11274591-127459155.39855.151.1356.4556.201.12
21290116-129011656.07257.13
31267343-126734355.08356.14
41248779-124877954.27655.32
51258386-125838654.69355.75
61273745-127374555.36156.42
极限11372506-137250659.65359.091.0661.0260.451.05
21363876-136387659.27860.65
31363208-136320859.24960.61
41356583-135658358.96160.31
51332296-133229657.90659.26
61368569-136856959.48260.85
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