奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.167593676083760427635376064760960.21
216.137644776390764180.06
单位质量响应值RSD%判断
4708.914737.630.43数据可信
供试品溶液-1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%
5min151059-5105970.01771.083.3570.0271.083.35
252256-5225671.65871.66
348992-4899267.18267.18
452153-5215371.51771.52
554258-5425874.40474.40
652266-5226671.67271.67
10min163742-6374287.40988.312.0987.5388.432.09
264677-6467788.69188.81
362265-6226585.38385.50
464685-6468588.70288.82
564657-6465788.66488.79
666354-6635490.99191.11
15min166494-6649491.18391.172.1891.4591.442.18
265954-6595490.44290.71
364603-6460388.59088.84
466293-6629390.90791.17
566532-6653291.23591.51
669050-6905094.68894.96
20min167589-6758992.68492.662.1093.1093.082.10
267910-6791093.12493.54
365184-6518489.38689.79
467588-6758892.68393.10
567532-6753292.60693.03
669622-6962295.47295.90
30min166728-6672891.50493.022.2692.0793.592.25
267892-6789293.10093.67
365950-6595090.43790.99
467723-6772392.86893.44
568310-6831093.67394.25
670411-7041196.55497.14
45min168405-6840593.80393.991.9694.5294.721.96
268998-6899894.61695.34
366812-6681291.61992.32
467920-6792093.13893.87
568278-6827893.62994.36
670849-7084997.15597.90
60min168010-6801093.26293.682.3594.1494.562.35
268961-6896194.56695.45
365758-6575890.17391.03
468156-6815693.46294.34
568264-6826493.61094.50
670724-7072496.98397.89
极限171365-7136597.86298.851.6798.9099.891.67
272441-7244199.338100.38
370337-7033796.45397.46
471818-7181898.48399.52
572767-7276799.785100.83
673799-73799101.200102.27
奥美沙坦酯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OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)10099.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.094643784644324645614641264643934643780.04
211.174661174657314659240.06
单位质量响应值RSD%判断
41873.5841712.090.28数据可信
供试品溶液-1批-奥美沙坦酯-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%
5min1179217-1792173897.9713975.353.253897.973975.353.25
2190234-1902344137.5914137.59
3173721-1737213778.4333778.43
4185144-1851444026.8834026.88
5187012-1870124067.5124067.51
6181321-1813213943.7333943.73
10min1279210-2792106072.8196090.832.136079.326097.462.13
2285281-2852816204.8646211.76
3269011-2690115850.9915857.29
4279449-2794496078.0186084.73
5284155-2841556180.3736187.15
6283123-2831236157.9276164.50
15min1325274-3252747074.7127050.981.667091.337067.761.66
2326460-3264607100.5077117.74
3314602-3146026842.5966858.64
4323118-3231187027.8197044.66
5324782-3247827064.0117081.09
6330861-3308617196.2297213.07
20min1346124-3461247528.1997550.031.677556.617578.561.67
2352118-3521187658.5697687.64
3336275-3362757313.9837341.44
4347941-3479417567.7197596.27
5348683-3486837583.8587612.71
6351626-3516267647.8687676.70
30min1358690-3586907801.5107950.751.867842.477991.871.86
2370117-3701178050.0478091.88
3356192-3561927747.1787786.82
4366284-3662847966.6798007.85
5368247-3682478009.3758050.87
6373781-3737818129.7398171.32
45min1370314-3703148054.3328141.531.968108.298195.901.95
2382040-3820408309.3738364.63
3363324-3633247902.2997954.85
4372443-3724438100.6388155.08
5375412-3754128165.2138220.06
6382406-3824068317.3338372.46
60min1368519-3685198015.2918121.731.968082.678189.661.95
2381143-3811438289.8638358.96
3362310-3623107880.2457945.97
4372842-3728428109.3168177.26
5374754-3747548150.9028219.35
6380909-3809098284.7738353.76
极限1394992-3949928591.0798702.172.098671.828783.642.09
2409460-4094608905.7588988.68
3387264-3872648422.9958501.85
4398099-3980998658.6568740.12
5403263-4032638770.9738853.01
6407519-4075198863.5418946.34
奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.163845938498386003842938799385570.39
216.133896638856389110.20
单位质量响应值RSD%判断
2385.952412.340.78数据可信
供试品溶液-2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%
5min124128-2412865.14070.565.0365.1470.565.03
226950-2695072.75972.76
327706-2770674.80074.80
426355-2635571.15271.15
525054-2505467.64067.64
626629-2662971.89271.89
10min134032-3403291.87890.782.4891.9990.902.48
234604-3460493.42293.54
333097-3309789.35489.48
433737-3373791.08291.20
532251-3225187.07087.18
634040-3404091.90092.02
15min135017-3501794.53793.183.8194.8093.453.80
235302-3530295.30795.58
334180-3418092.27892.55
435214-3521495.06995.34
531987-3198786.35786.62
635381-3538195.52095.79
20min134865-3486594.12794.092.4994.5594.512.49
234728-3472893.75794.19
334234-3423492.42492.85
435640-3564096.21996.65
533647-3364790.83991.24
635985-3598597.15197.58
30min135348-3534895.43195.441.5996.0196.021.59
235723-3572396.44497.04
334865-3486594.12794.71
436051-3605197.32997.92
534543-3454393.25893.81
635568-3556896.02596.62
45min135418-3541895.62095.142.4896.3695.882.48
236071-3607197.38398.14
334457-3445793.02693.76
436146-3614697.58698.34
533965-3396591.69792.41
635379-3537995.51596.27
60min135684-3568496.33895.351.7097.2396.251.70
235783-3578396.60697.52
334541-3454193.25294.15
435791-3579196.62797.54
534562-3456293.30994.17
635543-3554395.95896.87
极限136793-3679399.33298.482.85100.3999.542.84
237242-37242100.544101.62
334591-3459193.38794.44
437346-37346100.825101.90
536000-3600097.19198.21
636896-3689699.610100.68
奥美沙坦酯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OM230503W对照品来源原料药对照品使用方法直接使用
对照品含量(%)10099.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.092351982352582354772353772359152354450.13
211.172380732373442377080.22
单位质量响应值RSD%判断
21230.3921280.930.17数据可信
供试品溶液-2批-奥美沙坦酯-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%
5min1101876-1018764356.6984475.264.104356.704475.264.10
2109052-1090524663.5784663.58
3107627-1076274602.6384602.64
4104677-1046774476.4824476.48
597577-975774172.8534172.85
6107082-1070824579.3324579.33
10min1152127-1521276505.6686476.413.106512.936483.873.10
2152848-1528486536.5026544.27
3150860-1508606451.4856459.16
4155695-1556956658.2536665.71
5142551-1425516096.1536103.11
6154576-1545766610.3996618.03
15min1174290-1742907453.4637392.842.587471.577411.102.58
2173679-1736797427.3337446.00
3169400-1694007244.3437262.77
4177341-1773417583.9387602.50
5165820-1658207091.2467108.36
6176705-1767057556.7407575.39
20min1184773-1847737901.7657824.092.847932.297854.662.84
2185225-1852257921.0957952.14
3177002-1770027569.4417599.94
4187561-1875618020.9938052.19
5175860-1758607520.6037549.54
6187319-1873198010.6448041.89
30min1195408-1954088356.5688196.472.438400.268240.082.43
2193664-1936648281.9868326.23
3185422-1854227929.5207972.63
4195828-1958288374.5298419.10
5186150-1861507960.6528002.12
6193514-1935148275.5728320.17
45min1197791-1977918458.4768338.022.248516.108395.292.24
2197332-1973328438.8478496.90
3188355-1883558054.9498111.28
4199134-1991348515.9098574.43
5190702-1907028155.3178210.05
6196531-1965318404.5938462.98
60min1197732-1977328455.9538319.432.248527.678390.602.23
2197651-1976518452.4898524.60
3187239-1872398007.2238076.98
4196991-1969918424.2658496.98
5191167-1911678175.2038243.53
6196458-1964588401.4718473.87
极限1208895-2088958933.3368849.022.199019.158934.062.19
2208879-2088798932.6529018.85
3199253-1992538520.9988604.10
4211110-2111109028.0609114.82
5203705-2037058711.3878793.34
6209698-2096988967.6769054.07
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