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%
115.951847618452184281847118509184670.17
215.861844618424184350.09
单位质量响应值RSD%判断
1157.811162.360.28数据可信
供试品溶液-2024080421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%
5min116823-1682391.56091.274.4791.5691.274.47
216047-1604787.33787.34
317872-1787297.27097.27
417420-1742094.80994.81
516068-1606887.45187.45
616391-1639189.20989.21
10min117435-1743594.89195.312.2495.0495.462.24
217183-1718393.52093.67
318195-1819599.02799.19
417715-1771596.41596.57
517153-1715393.35693.50
617390-1739094.64694.79
15min117502-1750295.25695.482.3895.5795.792.38
217280-1728094.04894.35
318147-1814798.76699.09
417780-1778096.76997.09
517612-1761295.85496.16
616934-1693492.16492.47
20min117494-1749495.21296.261.8295.6896.741.83
217286-1728694.08094.54
318163-1816398.85399.35
417886-1788697.34697.83
517805-1780596.90597.37
617490-1749095.19095.65
30min117490-1749095.19096.351.3795.8296.981.37
217721-1772196.44897.06
317885-1788597.34098.00
417853-1785397.16697.81
517332-1733294.33194.95
617932-1793297.59698.21
45min117590-1759095.73595.991.5396.5296.781.53
217360-1736094.48395.26
318121-1812198.62599.44
417563-1756395.58896.39
517733-1773396.51397.29
617450-1745094.97395.75
60min117500-1750095.24595.651.6696.1996.601.66
217256-1725693.91794.85
318033-1803398.14699.13
417784-1778496.79197.75
517544-1754495.48496.43
617329-1732994.31495.25
极限117414-1741494.77795.561.2595.8896.671.26
217372-1737294.54895.64
317938-1793897.62998.78
417691-1769196.28497.41
517512-1751295.31096.41
617417-1741794.79395.89
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%
110.972284122283402282422285282284862284020.06
211.122281342277392279360.13
单位质量响应值RSD%判断
20820.6020497.841.11数据可信
供试品溶液-2024080421批-奥美沙坦酯-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%
5min198399-9839942.78342.936.1742.7842.926.17
296406-9640641.91741.92
3107864-10786446.89946.90
4103953-10395345.19845.20
592603-9260340.26340.26
693127-9312740.49140.49
10min1147144-14714463.97863.893.3364.0563.973.33
2144388-14438862.77962.85
3155406-15540667.57067.65
4149091-14909164.82464.90
5144022-14402262.62062.69
6141667-14166761.59661.66
15min1169915-16991573.87873.972.4074.0674.152.41
2167402-16740272.78672.96
3177362-17736277.11677.31
4170681-17068174.21174.39
5170056-17005673.94074.11
6165352-16535271.89472.06
20min1181881-18188179.08179.412.1779.3879.712.17
2179803-17980378.17878.47
3189128-18912882.23282.55
4182195-18219579.21879.52
5184905-18490580.39680.69
6177940-17794077.36877.66
30min1196928-19692885.62488.672.7186.0689.102.69
2204575-20457588.94889.37
3202250-20225087.93888.39
4207097-20709790.04590.48
5200098-20009887.00287.43
6212601-21260192.43892.86
45min1198931-19893186.49487.351.6887.0787.931.68
2198271-19827186.20786.78
3204859-20485989.07289.67
4200491-20049187.17387.76
5205251-20525189.24289.82
6197573-19757385.90486.48
60min1202050-20205087.85188.471.4088.5789.191.40
2201040-20104087.41188.13
3206576-20657689.81890.57
4203157-20315788.33289.07
5207302-20730290.13490.86
6200659-20065987.24687.96
极限1215216-21521693.57593.531.1294.4494.401.13
2213728-21372892.92893.79
3219078-21907895.25496.16
4214773-21477393.38294.26
5215981-21598193.90894.78
6211875-21187592.12292.98
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%
115.951846418501184621852918492184900.16
215.861844318449184460.03
单位质量响应值RSD%判断
1159.251163.050.24数据可信
供试品溶液-2024080421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%
5min116840-1684091.56892.521.6791.5792.521.67
217315-1731594.15194.15
316773-1677391.20491.20
417114-1711493.05893.06
516701-1670190.81390.81
617351-1735194.34794.35
10min116963-1696392.23795.612.1792.3995.762.17
217775-1777596.65396.81
317781-1778196.68596.84
417842-1784297.01797.17
517254-1725493.82093.97
617882-1788297.23497.39
15min117340-1734094.28796.241.6894.5996.551.68
217853-1785397.07797.39
317602-1760295.71296.02
417944-1794497.57197.89
517399-1739994.60894.92
618058-1805898.19198.51
20min117403-1740394.63096.021.9295.0996.501.92
217846-1784697.03997.52
317774-1777496.64797.12
417891-1789197.28397.76
517092-1709292.93993.40
617949-1794997.59998.08
30min117440-1744094.83195.961.9695.4596.591.96
217911-1791197.39298.03
317884-1788497.24597.88
417708-1770896.28896.93
517046-1704692.68993.31
617894-1789497.30097.95
45min117502-1750295.16895.731.9195.9596.531.90
217189-1718993.46694.27
318111-1811198.48099.28
417849-1784997.05597.86
517633-1763395.88096.66
617351-1735194.34795.15
60min117439-1743994.82695.861.0595.7696.811.06
217782-1778296.69197.65
317601-1760195.70696.67
417755-1775596.54497.51
517382-1738294.51695.45
617812-1781296.85497.82
极限117448-1744894.87495.431.2295.9796.551.22
217719-1771996.34897.47
317712-1771296.31097.43
417682-1768296.14797.27
517171-1717193.36894.46
617574-1757495.56096.69
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%
110.972287012288442286632286262286052286880.05
211.122277682272322275000.17
单位质量响应值RSD%判断
20846.6720458.631.33数据可信
供试品溶液-2024080421批-奥美沙坦酯-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%
5min1100382-10038243.66144.572.9443.6644.572.94
2107497-10749746.75546.76
3100342-10034243.64343.64
4100833-10083343.85743.86
5100880-10088043.87743.88
6104869-10486945.61245.61
10min1144926-14492663.03564.572.5663.1164.652.56
2152873-15287366.49266.57
3146174-14617463.57863.65
4148777-14877764.71064.78
5144881-14488163.01563.09
6153122-15312266.60066.68
15min1165104-16510471.81173.872.5671.9974.052.56
2172232-17223274.91275.10
3166902-16690272.59372.77
4170954-17095474.35674.54
5167009-16700972.64072.82
6176758-17675876.88077.07
20min1176762-17676276.88279.312.6277.1879.622.62
2184639-18463980.30880.62
3179824-17982478.21478.51
4184092-18409280.07080.37
5178909-17890977.81678.12
6189847-18984782.57382.89
30min1187590-18759081.59284.602.7782.0285.042.76
2196038-19603885.26685.71
3192184-19218483.59084.02
4196936-19693685.65786.09
5191324-19132483.21683.64
6203034-20303488.30988.76
45min1192907-19290783.90484.162.0884.4784.742.05
2190074-19007482.67283.26
3199216-19921686.64887.22
4192708-19270883.81884.40
5197197-19719785.77086.34
6188885-18888582.15582.75
60min1202268-20226887.97689.982.3388.6890.702.32
2207376-20737690.19790.92
3206475-20647589.80690.52
4209266-20926691.01991.74
5201382-20138287.59088.30
6214475-21447593.28594.02
极限1211484-21148491.98493.321.4792.8394.181.48
2215433-21543393.70294.58
3214497-21449793.29594.16
4215779-21577993.85294.72
5210733-21073391.65892.51
6219382-21938295.41996.31
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