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%
115.951840118386182151861518356183950.79
215.861846718411184390.22
单位质量响应值RSD%判断
1153.291162.610.57数据可信
供试品溶液-2024080121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%
5min115686-1568685.53088.163.0285.5388.163.02
216881-1688192.04692.05
316619-1661990.61890.62
416065-1606587.59787.60
516058-1605887.55987.56
615700-1570085.60785.61
10min116690-1669091.00592.641.6791.1592.791.67
217506-1750695.45495.61
317060-1706093.02293.17
416901-1690192.15592.30
516975-1697592.55992.70
616813-1681391.67591.82
15min117288-1728894.26594.191.6994.5694.491.69
217500-1750095.42195.73
317524-1752495.55295.86
417258-1725894.10294.40
517347-1734794.58794.89
616723-1672391.18591.48
20min117086-1708693.16493.501.5193.6293.961.51
217383-1738394.78395.25
317386-1738694.80095.27
416796-1679691.58392.04
517330-1733094.49494.95
616901-1690192.15592.60
30min117142-1714293.46993.361.0994.0893.981.09
217411-1741194.93695.57
317082-1708293.14293.77
416955-1695592.45093.06
517234-1723493.97194.59
616909-1690992.19992.80
45min117036-1703692.89193.440.5493.6594.210.53
217111-1711193.30094.09
317098-1709893.22994.01
417081-1708193.13793.90
517218-1721893.88494.66
617276-1727694.20094.95
60min116959-1695992.47193.541.1193.3994.471.10
217160-1716093.56794.51
316929-1692992.30893.24
417325-1732594.46795.39
517405-1740594.90395.83
617155-1715593.54094.45
极限117146-1714693.49194.120.6994.5695.200.68
217212-1721293.85194.95
317165-1716593.59594.68
417278-1727894.21195.29
517470-1747095.25896.34
617296-1729694.30995.38
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%
110.972288562286302286082289332285422287140.08
211.122288072275652281860.39
单位质量响应值RSD%判断
20849.0420520.321.13数据可信
供试品溶液-2024080121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%
5min191171-9117139.59240.564.9739.5940.564.96
297970-9797042.54542.54
397073-9707342.15542.16
492791-9279140.29640.30
595822-9582241.61241.61
685538-8553837.14637.15
10min1146709-14670963.71063.252.1463.7863.322.15
2149044-14904464.72464.80
3147450-14745064.03264.10
4143043-14304362.11862.19
5146954-14695463.81763.89
6140747-14074761.12161.18
15min1172789-17278975.03673.881.5575.2174.051.55
2172729-17272975.01075.19
3171104-17110474.30474.48
4168258-16825873.06873.24
5169748-16974873.71573.89
6166111-16611172.13672.30
20min1185031-18503180.35279.111.5980.6579.411.59
2184959-18495980.32180.62
3183901-18390179.86180.16
4180028-18002878.17978.47
5181044-18104478.62078.92
6178090-17809077.33877.62
30min1195890-19589085.06883.551.4785.5083.981.47
2195191-19519184.76485.20
3193447-19344784.00784.44
4189294-18929482.20382.63
5190510-19051082.73183.16
6190028-19002882.52282.93
45min1197329-19732985.69286.301.0586.2786.871.04
2199894-19989486.80687.39
3200481-20048187.06187.64
4195408-19540884.85885.42
5198596-19859686.24386.81
6200712-20071287.16287.71
60min1200625-20062587.12487.870.8887.8488.580.87
2202481-20248187.93088.65
3202737-20273788.04188.76
4200101-20010186.89687.60
5203175-20317588.23188.94
6204929-20492988.99389.69
极限1212690-21269092.36393.020.9693.2293.870.95
2213597-21359792.75793.63
3212966-21296692.48393.35
4212675-21267592.35793.20
5217797-21779794.58195.44
6215426-21542693.55194.40
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%
115.951841618166183871838018374183450.56
215.861867218573186220.38
单位质量响应值RSD%判断
1150.161174.151.46数据可信
供试品溶液-2024080121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%
5min116535-1653589.84292.362.6789.8492.362.67
216389-1638989.04889.05
317528-1752895.23795.24
417186-1718693.37993.38
516996-1699692.34692.35
617352-1735294.28194.28
10min117251-1725193.73294.921.5793.8895.081.57
217111-1711192.97193.12
317775-1777596.57996.74
417528-1752895.23795.39
517775-1777596.57996.73
617383-1738394.44994.61
15min117397-1739794.52594.832.8194.8395.142.80
216559-1655989.97290.28
317759-1775996.49296.81
417632-1763295.80296.12
517968-1796897.62897.94
617400-1740094.54294.86
20min117315-1731594.08094.991.8094.5495.461.80
217049-1704992.63493.09
317930-1793097.42197.90
417327-1732794.14594.62
517685-1768596.09096.57
617591-1759195.57996.05
30min117207-1720793.49394.901.7994.1195.531.79
217137-1713793.11393.72
317928-1792897.41098.05
417292-1729293.95594.59
517715-1771596.25396.89
617521-1752195.19995.83
45min117458-1745894.85794.331.7495.6395.111.74
216879-1687991.71192.47
317697-1769796.15596.96
417440-1744094.75995.55
517556-1755695.38996.19
617131-1713193.08093.87
60min117335-1733594.18894.301.4795.1295.241.47
216976-1697692.23893.15
317547-1754795.34096.31
417429-1742994.69995.64
517675-1767596.03696.99
617171-1717193.29794.24
极限117154-1715493.20594.511.1494.3095.621.14
217260-1726093.78194.85
317594-1759495.59696.72
417395-1739594.51495.62
517659-1765995.94997.07
617305-1730594.02595.13
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%
110.972271262277172270262275392272422273300.13
211.122301262292212296740.28
单位质量响应值RSD%判断
20722.8820654.140.24数据可信
供试品溶液-2024080121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%
5min188259-8825938.31840.784.0838.3240.784.08
290139-9013939.13439.13
397419-9741942.29542.29
495827-9582741.60441.60
594806-9480641.16141.16
697116-9711642.16342.16
10min1142888-14288862.03664.123.3762.1064.193.37
2140543-14054361.01761.08
3152677-15267766.28666.36
4150544-15054465.35965.43
5147783-14778364.16164.23
6151726-15172665.87365.94
15min1170837-17083774.17074.992.5274.3475.172.53
2165295-16529571.76471.93
3177464-17746477.04777.23
4175021-17502175.98676.16
5172256-17225674.78674.96
6175538-17553876.21176.39
20min1183577-18357779.70180.642.9379.9980.942.93
2176838-17683876.77577.06
3191056-19105682.94883.26
4188373-18837381.78382.09
5183915-18391579.84880.15
6190705-19070582.79683.10
30min1196165-19616585.16686.012.7785.5986.442.77
2188449-18844981.81682.23
3204508-20450888.78889.24
4200231-20023186.93187.37
5198411-19841186.14186.57
6200850-20085087.20087.65
45min1206230-20623089.53688.942.8990.1089.522.89
2194494-19449484.44184.99
3212031-21203192.05492.65
4206376-20637689.59990.19
5202657-20265787.98588.56
6207414-20741490.05090.64
60min1209127-20912790.79490.162.7391.5190.892.73
2198503-19850386.18186.87
3215491-21549193.55794.31
4207448-20744890.06590.80
5205258-20525889.11489.84
6210190-21019091.25592.00
极限1215615-21561593.61093.332.3894.4894.202.38
2205834-20583489.36490.20
3221498-22149896.16597.07
4215084-21508493.38094.27
5214954-21495493.32394.20
6216788-21678894.12095.01
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%
115.951845318363183951835218456184040.27
215.861857318421184970.59
单位质量响应值RSD%判断
1153.861166.270.76数据可信
供试品溶液-2024080321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%
5min117144-1714493.31190.893.9493.3190.893.94
216316-1631688.80588.80
317318-1731894.25894.26
415551-1555184.64184.64
516895-1689591.95691.96
616975-1697592.39192.39
10min117636-1763695.98993.803.1196.1493.953.11
217361-1736194.49294.64
317346-1734694.41194.57
416167-1616787.99488.13
517365-1736594.51494.67
617530-1753095.41295.57
15min117964-1796497.77494.772.0298.0995.082.02
217543-1754395.48395.79
317399-1739994.69995.01
416939-1693992.19692.48
517156-1715693.37793.69
617474-1747495.10795.42
20min117833-1783397.06193.893.6397.5494.353.62
217663-1766396.13696.60
317705-1770596.36596.84
416855-1685591.73892.18
517233-1723393.79694.26
616209-1620988.22288.69
30min117864-1786497.23094.312.0897.8794.942.08
217618-1761895.89196.52
317207-1720793.65494.29
416839-1683991.65192.25
517218-1721893.71494.34
617219-1721993.71994.34
45min117377-1737794.57993.981.0695.3894.761.06
217179-1717993.50294.29
317543-1754395.48396.27
417080-1708092.96393.71
517331-1733194.32995.11
617092-1709293.02893.80
60min117819-1781996.98594.611.6797.9595.551.68
217454-1745494.99995.94
317458-1745895.02095.97
416930-1693092.14793.05
517363-1736394.50395.44
617271-1727194.00394.93
极限117534-1753495.43494.001.7796.5695.101.77
217475-1747595.11396.21
317541-1754195.47296.58
416871-1687191.82592.88
516923-1692392.10893.20
617282-1728294.06295.15
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%
110.972285822289672285592284792284712286120.09
211.122298162291142294650.22
单位质量响应值RSD%判断
20839.7420635.340.70数据可信
供试品溶液-2024080321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%
5min199158-9915842.94942.373.8642.9542.373.86
295849-9584941.51641.52
3102996-10299644.61144.61
491700-9170039.71939.72
598489-9848942.65942.66
698694-9869442.74842.75
10min1147723-14772363.98462.273.1464.0662.343.13
2147976-14797664.09464.16
3146556-14655663.47963.55
4136499-13649959.12359.19
5142466-14246661.70761.78
6141388-14138861.24161.31
15min1172534-17253474.73172.193.3574.9172.363.34
2173357-17335775.08875.26
3167597-16759772.59372.77
4159467-15946769.07169.24
5164896-16489671.42371.60
6162162-16216270.23970.41
20min1184121-18412179.75077.733.3180.0578.033.30
2188045-18804581.44981.75
3180479-18047978.17278.47
4171946-17194674.47674.76
5176457-17645776.43076.72
6175734-17573476.11776.41
30min1197425-19742585.51282.823.7985.9583.243.79
2201295-20129587.18987.63
3192255-19225583.27383.70
4182406-18240679.00779.41
5188757-18875781.75882.18
6185087-18508780.16880.59
45min1197059-19705985.35484.011.2485.9384.571.23
2190345-19034582.44683.03
3193712-19371283.90484.47
4196211-19621184.98685.52
5193328-19332883.73884.29
6193112-19311283.64484.20
60min1208163-20816390.16387.643.7690.8888.343.75
2213130-21313092.31593.03
3203817-20381788.28188.99
4192819-19281983.51784.19
5200164-20016486.69987.39
6195943-19594384.87085.56
极限1217127-21712794.04692.072.0894.9292.922.08
2218495-21849594.63895.51
3213122-21312292.31193.17
4208431-20843190.27991.10
5209348-20934890.67791.52
6208898-20889890.48291.31
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%
115.951835718440184201826018334183620.40
215.861860618678186420.28
单位质量响应值RSD%判断
1151.221175.411.48数据可信
供试品溶液-2024080321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%
5min116509-1650989.61190.282.1489.6190.282.14
216849-1684991.45691.46
316244-1624488.17288.17
416504-1650489.58489.58
516450-1645089.29189.29
617241-1724193.58493.58
10min117188-1718893.29693.730.6493.4593.880.64
217107-1710792.85793.01
317349-1734994.17094.32
417266-1726693.72093.87
517282-1728293.80793.96
617412-1741294.51294.67
15min117408-1740894.49193.801.3194.8094.111.31
217405-1740594.47494.78
316844-1684491.42991.73
417283-1728393.81294.12
517463-1746394.78995.09
617283-1728393.81294.13
20min117440-1744094.66494.301.1395.1394.771.12
217070-1707092.65693.12
317502-1750295.00195.46
417356-1735694.20894.67
517622-1762295.65296.12
617249-1724993.62894.10
30min117479-1747994.87694.041.7295.5094.661.71
217494-1749494.95795.58
317640-1764095.75096.36
416791-1679191.14291.76
517252-1725293.64494.27
617291-1729193.85694.48
45min117481-1748194.88793.541.1795.6794.311.17
217175-1717593.22694.00
317486-1748694.91495.69
417040-1704092.49393.26
517060-1706092.60293.38
617150-1715093.09093.87
60min117389-1738994.38793.721.3095.3294.651.29
217377-1737794.32295.26
317479-1747994.87695.81
416986-1698692.20093.12
517387-1738794.37795.31
616974-1697492.13593.07
极限117313-1731393.97592.891.0395.0793.981.02
216922-1692291.85392.94
317180-1718093.25394.34
416914-1691491.80992.89
517290-1729093.85094.94
617063-1706392.61893.71
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%
110.972273562264302273462270082266452269570.19
211.122332672324202328440.26
单位质量响应值RSD%判断
20688.8820939.210.86数据可信
供试品溶液-2024080321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%
5min194861-9486140.93741.863.5840.9441.863.58
299634-9963442.99743.00
392590-9259039.95739.96
4100274-10027443.27343.27
594301-9430140.69640.70
6100357-10035743.30943.31
10min1144549-14454962.38062.281.2262.4562.351.22
2143591-14359161.96762.04
3141421-14142161.03061.10
4146681-14668163.30063.37
5144389-14438962.31162.38
6145232-14523262.67562.75
15min1168912-16891272.89472.150.9973.0772.330.99
2165306-16530671.33871.51
3166078-16607871.67171.84
4169342-16934273.08073.26
5167378-16737872.23272.40
6166165-16616571.70971.89
20min1183241-18324179.07877.801.2379.3778.091.23
2176965-17696576.36976.66
3179204-17920477.33677.62
4181912-18191278.50478.80
5180854-18085478.04878.34
6179479-17947977.45477.75
30min1202261-20226187.28685.143.8987.7185.563.87
2208516-20851689.98590.41
3199164-19916485.94986.37
4187723-18772381.01281.44
5195388-19538884.32084.74
6190650-19065082.27582.70
45min1206605-20660589.16187.411.7089.7387.981.68
2196360-19636084.73985.31
3203772-20377287.93888.50
4203861-20386187.97688.54
5201787-20178787.08187.64
6202921-20292187.57188.13
60min1208421-20842189.94488.661.4190.6689.371.39
2200112-20011286.35987.07
3207220-20722089.42690.13
4206199-20619988.98589.70
5204929-20492988.43789.15
6205826-20582688.82489.53
极限1215013-21501392.78991.781.0693.6692.641.05
2210757-21075790.95291.81
3215690-21569093.08193.94
4210485-21048590.83591.70
5211255-21125591.16792.02
6212795-21279591.83292.69
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