奥美沙坦酯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%
115.951808218254184101830018176182440.69
215.861839818486184420.34
单位质量响应值RSD%判断
1143.821162.801.17数据可信
供试品溶液-2024080121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%
5min116313-1631389.31188.642.1389.3188.642.13
215974-1597487.45587.46
315875-1587586.91386.91
416692-1669291.38691.39
515847-1584786.76086.76
616436-1643689.98589.98
10min116950-1695092.79993.801.4792.9593.951.47
216889-1688992.46592.61
316992-1699293.02993.17
417562-1756296.15096.30
517144-1714493.86194.01
617260-1726094.49694.65
15min116997-1699793.05694.401.3893.3694.711.38
217015-1701593.15593.45
317287-1728794.64494.94
417436-1743695.46095.77
517587-1758796.28696.59
617137-1713793.82394.13
20min117258-1725894.48593.731.7394.9494.191.73
216586-1658690.80691.26
317030-1703093.23793.69
417146-1714693.87294.34
517262-1726294.50794.97
617440-1744095.48295.95
30min116806-1680692.01193.861.8192.6394.481.80
216755-1675591.73192.34
317247-1724794.42595.04
417512-1751295.87696.50
517400-1740095.26395.88
617147-1714793.87794.50
45min116916-1691692.61392.861.9493.3893.641.91
217258-1725894.48595.24
317146-1714693.87294.64
416335-1633589.43290.22
517021-1702193.18893.97
617093-1709393.58294.36
60min116991-1699193.02393.171.2593.9594.101.24
217308-1730894.75995.68
316805-1680592.00592.93
417214-1721494.24495.18
517012-1701293.13894.07
616780-1678091.86892.80
极限117462-1746295.60294.321.0796.6895.401.06
217099-1709993.61594.69
317218-1721894.26695.35
417438-1743895.47196.56
517016-1701693.16094.25
617133-1713393.80194.89
奥美沙坦酯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100864-202205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500
标示量(mg)20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%
110.972259202262182251912268102255262259330.28
211.122267632275032271330.24
单位质量响应值RSD%判断
20595.5320425.630.59数据可信
供试品溶液-2024080121批-奥美沙坦酯-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%
5min110023-100234.3894.495.854.394.495.87
210210-102104.4714.47
39773-97734.2804.28
410759-107594.7124.71
59599-95994.2044.20
611163-111634.8894.89
10min119670-196708.6148.782.048.628.792.07
219494-194948.5378.54
320316-203168.8978.90
420385-203858.9278.94
519949-199498.7368.74
620485-204858.9718.98
15min126403-2640311.56311.561.3511.5811.581.34
226191-2619111.47011.49
326560-2656011.63111.65
426805-2680511.73911.76
525792-2579211.29511.32
626572-2657211.63711.66
20min131067-3106713.60513.470.9413.6513.510.94
230414-3041413.31913.36
330852-3085213.51113.55
430783-3078313.48113.52
530392-3039213.31013.35
630992-3099213.57213.61
30min136241-3624115.87115.880.8115.9315.940.80
236056-3605615.79015.85
335905-3590515.72415.79
436761-3676116.09916.16
536277-3627715.88715.95
636342-3634215.91515.98
45min141088-4108817.99417.960.3818.0818.050.37
240908-4090817.91518.00
341016-4101617.96218.05
441264-4126418.07118.16
540978-4097817.94518.03
640817-4081717.87517.97
60min143624-4362419.10419.090.4719.2219.210.46
243569-4356919.08019.20
343667-4366719.12319.24
443612-4361219.09919.22
543873-4387319.21319.33
643248-4324818.94019.06
极限145841-4584120.07520.040.6020.2320.200.60
245819-4581920.06520.22
345656-4565619.99420.15
445774-4577420.04620.20
546185-4618520.22620.38
645352-4535219.86120.01
奥美沙坦酯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%
115.951849018523183771868818386184930.69
215.861845618477184660.09
单位质量响应值RSD%判断
1159.441164.310.30数据可信
供试品溶液-2024080321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%
5min116290-1629088.52389.601.6088.5289.601.60
216274-1627488.43688.44
316719-1671990.85490.85
416585-1658590.12690.13
516218-1621888.13188.13
616841-1684191.51791.52
10min117303-1730394.02794.121.5194.1894.261.51
217422-1742294.67494.82
317026-1702692.52292.67
417000-1700092.38192.53
517626-1762695.78395.93
617538-1753895.30595.46
15min117473-1747394.95194.940.7195.2695.240.71
217578-1757895.52295.83
317592-1759295.59895.90
417377-1737794.43094.73
517276-1727693.88194.19
617528-1752895.25095.56
20min117467-1746794.91994.341.8595.3894.801.84
217522-1752295.21895.68
317088-1708892.85993.32
417145-1714593.16993.63
517065-1706592.73493.20
617878-1787897.15297.62
30min116821-1682191.40892.440.7992.0393.060.79
217018-1701892.47993.10
317083-1708392.83293.45
417115-1711593.00693.62
516877-1687791.71392.33
617148-1714893.18593.82
45min117302-1730294.02294.191.5894.8094.961.57
217518-1751895.19695.97
317447-1744794.81095.58
416986-1698692.30593.08
517052-1705292.66493.43
617689-1768996.12596.91
60min117244-1724493.70794.001.8694.6494.931.85
217583-1758395.54996.48
317602-1760295.65296.58
416957-1695792.14793.07
516881-1688191.73492.66
617516-1751695.18596.13
极限117433-1743394.73493.871.3895.8294.961.37
217420-1742094.66395.76
317483-1748395.00696.10
416869-1686991.66992.75
517118-1711893.02294.10
617316-1731694.09895.20
奥美沙坦酯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100864-202205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500
标示量(mg)20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%
110.972280292281632281312282322287242282560.12
211.122282372279392280880.10
单位质量响应值RSD%判断
20807.2920511.511.02数据可信
供试品溶液-2024080321批-奥美沙坦酯-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%
5min112376-123765.3815.552.875.385.552.87
212472-124725.4235.42
313247-132475.7605.76
412852-128525.5885.59
512509-125095.4395.44
613117-131175.7035.70
10min121141-211419.1929.211.169.209.221.15
220982-209829.1239.13
321648-216489.4129.42
421063-210639.1589.17
521020-210209.1399.15
621213-212139.2239.23
15min127291-2729111.86611.860.8311.8911.880.82
227525-2752511.96811.99
327389-2738911.90811.93
427299-2729911.86911.89
526855-2685511.67611.70
627258-2725811.85111.88
20min131290-3129013.60513.660.7513.6513.700.76
231629-3162913.75213.80
331472-3147213.68413.73
431550-3155013.71813.76
531003-3100313.48013.52
631552-3155213.71813.76
30min136586-3658615.90716.020.5115.9716.090.51
237006-3700616.09016.16
336784-3678415.99316.06
436969-3696916.07416.14
536728-3672815.96916.04
637063-3706316.11516.18
45min141504-4150418.04518.120.6818.1418.210.66
241813-4181318.18018.27
341179-4117917.90418.00
441835-4183518.18918.28
541844-4184418.19318.29
641883-4188318.21018.30
60min144012-4401219.13619.260.7219.2619.390.72
244832-4483219.49219.62
343957-4395719.11219.24
444242-4424219.23619.36
544333-4433319.27519.40
644444-4444419.32419.45
极限146042-4604220.01920.100.6120.1720.260.61
246770-4677020.33520.49
346047-4604720.02120.18
446203-4620320.08920.24
546060-4606020.02620.18
646290-4629020.12620.28
奥美沙坦酯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%
115.951829818179181581828418228182290.34
215.861808118236181580.61
单位质量响应值RSD%判断
1142.881144.890.13数据可信
供试品溶液-2024080321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%
5min116562-1656291.41690.642.4291.4290.652.42
216184-1618489.32989.33
316736-1673692.37692.38
415971-1597188.15388.15
516975-1697593.69593.70
616106-1610688.89988.90
10min116893-1689393.24394.042.9993.3994.192.99
217249-1724995.20895.36
317257-1725795.25295.41
416075-1607588.72888.87
517490-1749096.53896.69
617265-1726595.29695.44
15min117043-1704394.07095.290.9794.3895.600.97
217144-1714494.62894.94
317331-1733195.66095.97
417183-1718394.84395.14
517437-1743796.24596.56
617451-1745196.32296.63
20min117325-1732595.62795.480.9496.0995.940.94
217340-1734095.71096.18
317096-1709694.36394.84
417179-1717994.82195.27
517276-1727695.35795.83
617569-1756996.97497.44
30min116923-1692393.40895.061.6694.0395.681.66
217298-1729895.47896.10
317047-1704794.09394.72
417071-1707194.22594.84
517730-1773097.86298.50
617263-1726395.28595.91
45min116969-1696993.66293.882.8494.4494.662.83
217156-1715694.69495.48
316481-1648190.96891.75
416738-1673892.38793.15
517879-1787998.68599.48
616831-1683192.90093.69
60min117159-1715994.71195.361.9395.6596.301.93
217447-1744796.30097.24
317307-1730795.52896.47
416666-1666691.99092.91
517525-1752596.73197.69
617553-1755396.88597.83
极限117112-1711294.45195.511.6395.5496.601.63
217384-1738495.95397.05
317120-1712094.49595.59
417256-1725695.24696.32
517833-1783398.43199.56
617113-1711394.45795.56
奥美沙坦酯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100864-202205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500
标示量(mg)20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%
110.972273942278832275922271112271642274290.14
211.122239272253452246360.45
单位质量响应值RSD%判断
20731.9120201.081.84数据可信
供试品溶液-2024080321批-奥美沙坦酯-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%
5min113799-137996.0575.963.406.065.963.40
213216-132165.8015.80
313457-134575.9075.91
414031-140316.1596.16
514008-140086.1496.15
612888-128885.6575.66
10min122017-220179.6649.631.529.679.641.53
221835-218359.5849.59
321694-216949.5229.53
422051-220519.6799.69
522488-224889.8719.88
621535-215359.4539.46
15min127522-2752212.08012.171.5112.1112.201.51
227757-2775712.18412.21
327333-2733311.99712.02
427977-2797712.28012.31
528423-2842312.47612.50
627382-2738212.01912.04
20min131989-3198914.04113.980.8414.0914.020.85
231955-3195514.02614.07
331504-3150413.82813.87
431771-3177113.94513.99
532216-3221614.14114.19
631603-3160313.87213.92
30min136929-3692916.21016.321.5816.2816.391.58
237328-3732816.38516.45
337057-3705716.26616.33
437376-3737616.40616.48
538067-3806716.70916.78
636291-3629115.92916.00
45min141578-4157818.25018.321.0618.3518.421.05
242201-4220118.52418.62
341434-4143418.18718.28
441586-4158618.25418.35
542365-4236518.59618.69
641280-4128018.11918.21
60min144207-4420719.40419.530.8319.5319.660.84
244719-4471919.62919.76
344428-4442819.50119.63
444540-4454019.55019.68
545063-4506319.78019.91
644035-4403519.32919.45
极限146042-4604220.21020.340.7920.3720.500.80
246366-4636620.35220.51
346049-4604920.21320.37
446543-4654320.42920.59
546938-4693820.60320.77
646030-4603020.20420.36
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