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%
115.951848518483185221850818552185100.16
215.861862418685186540.24
单位质量响应值RSD%判断
1160.501176.170.95数据可信
供试品溶液-2024080121批-20mg2.5mg-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%
5min116403-1640388.64787.653.1088.6587.653.10
216308-1630888.13488.13
315369-1536983.05983.06
415936-1593686.12486.12
516802-1680290.80490.80
616491-1649189.12389.12
10min116864-1686491.13993.481.5291.2993.621.51
217163-1716392.75592.90
317292-1729293.45293.59
417375-1737593.90194.04
517611-1761195.17695.33
617473-1747394.43094.58
15min117531-1753194.74494.011.6095.0494.311.60
216940-1694091.55091.85
317422-1742294.15594.45
417213-1721393.02593.33
517711-1771195.71696.03
617553-1755394.86295.17
20min117204-1720492.97693.711.1293.4394.171.11
217087-1708792.34492.80
317414-1741494.11194.56
417294-1729493.46393.92
517644-1764495.35495.82
617394-1739494.00394.47
30min117427-1742794.18292.910.8894.7993.530.86
217064-1706492.22092.83
317238-1723893.16093.77
417275-1727593.36093.97
517032-1703292.04792.68
617115-1711592.49593.12
45min117353-1735393.78292.421.4494.5593.191.42
216900-1690091.33392.10
317163-1716392.75593.52
417418-1741894.13394.90
516911-1691191.39392.17
616864-1686491.13991.91
60min117294-1729493.46392.741.1394.3993.661.12
216814-1681490.86991.78
317204-1720492.97693.89
417235-1723593.14494.07
517074-1707492.27493.21
617341-1734193.71794.64
极限117019-1701991.97793.751.8393.0694.821.81
217042-1704292.10193.17
317693-1769395.61996.69
417278-1727893.37694.45
517762-1776295.99297.08
617286-1728693.42094.50
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%
110.972261132267682271272272072270322268490.20
211.122284502291472287980.22
单位质量响应值RSD%判断
20679.0320575.360.36数据可信
供试品溶液-2024080121批-20mg2.5mg-坎地沙坦酯-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%
5min19853-98534.2904.444.434.294.444.47
210806-108064.7054.71
310074-100744.3874.39
49581-95814.1724.17
510339-103394.5024.50
610539-105394.5894.59
10min120339-203398.8578.880.688.868.890.70
220371-203718.8708.88
320381-203818.8758.88
420221-202218.8058.81
520623-206238.9808.99
620489-204898.9228.93
15min127045-2704511.77711.711.1011.8011.741.10
226532-2653211.55311.58
326640-2664011.60011.62
426785-2678511.66311.69
527317-2731711.89511.92
627052-2705211.78011.80
20min131443-3144313.69213.640.7213.7313.680.71
231099-3109913.54213.58
331035-3103513.51413.56
431266-3126613.61513.66
531605-3160513.76213.80
631476-3147613.70613.75
30min137141-3714116.17316.060.6916.2416.120.68
236426-3642615.86215.93
336838-3683816.04116.10
437080-3708016.14616.21
536831-3683116.03816.10
636909-3690916.07216.14
45min141538-4153818.08817.980.6218.1818.080.61
240939-4093917.82717.92
341095-4109517.89517.99
441593-4159318.11218.20
541370-4137018.01418.11
641261-4126117.96718.06
60min144149-4414919.22519.100.7119.3519.220.71
243606-4360618.98819.11
343756-4375619.05319.17
444223-4422319.25719.38
543437-4343718.91519.04
643956-4395619.14119.26
极限146585-4658520.28520.140.6620.4420.290.65
245758-4575819.92520.08
346106-4610620.07720.23
446525-4652520.25920.41
546178-4617820.10820.26
646313-4631320.16720.32
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%
115.951821718236182051820018207182130.08
215.861833018386183580.22
单位质量响应值RSD%判断
1141.881157.500.97数据可信
供试品溶液-2024080421批-20mg2.5mg-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%
5min116272-1627289.36690.992.1989.3790.992.19
215990-1599087.81787.82
316685-1668591.63491.63
416710-1671091.77191.77
516953-1695393.10693.11
616792-1679292.22192.22
10min117125-1712594.05095.281.9094.2095.431.89
217291-1729194.96295.11
317588-1758896.59396.75
417877-1787798.18098.33
517233-1723394.64394.80
616980-1698093.25493.41
15min117611-1761196.71996.450.7497.0296.760.74
217418-1741895.65995.96
317565-1756596.46796.78
417717-1771797.30197.62
517402-1740295.57195.88
617660-1766096.98897.30
20min117207-1720794.50195.971.5094.9796.441.50
217436-1743695.75896.22
317524-1752496.24296.72
417940-1794098.52699.00
517252-1725294.74895.22
617486-1748696.03396.50
30min117068-1706893.73794.442.0594.3695.082.04
216751-1675191.99692.62
317345-1734595.25895.89
417667-1766797.02797.67
516895-1689592.78793.42
617454-1745495.85796.49
45min117491-1749196.06095.581.6896.8496.371.67
217560-1756096.43997.22
317338-1733895.22096.01
417812-1781297.82398.63
517275-1727594.87495.66
616950-1695093.08993.88
60min117593-1759396.62096.161.1297.5697.101.12
217510-1751096.16597.10
317375-1737595.42396.38
417854-1785498.05499.02
517397-1739795.54496.49
617323-1732395.13896.08
极限117494-1749496.07796.561.4697.1897.671.45
217570-1757096.49497.59
317594-1759496.62697.74
418052-1805299.141100.27
517281-1728194.90796.01
617501-1750196.11597.22
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%
110.972265402264322263242263612269222265160.11
211.122251152251532251340.02
单位质量响应值RSD%判断
20648.6820245.861.40数据可信
供试品溶液-2024080421批-20mg2.5mg-坎地沙坦酯-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%
5min114411-144116.3316.264.866.336.254.85
213367-133675.8725.87
313793-137936.0606.06
415235-152356.6936.69
513873-138736.0956.09
614759-147596.4846.48
10min122407-224079.8449.851.929.859.861.94
222203-222039.7549.76
322004-220049.6679.68
423233-2323310.20710.22
522226-222269.7649.77
622505-225059.8879.90
15min128080-2808012.33612.311.5312.3612.341.54
227910-2791012.26112.29
327612-2761212.13012.16
428836-2883612.66812.70
527863-2786312.24112.27
627809-2780912.21712.24
20min131936-3193614.03014.101.3214.0814.141.32
232291-3229114.18614.23
331740-3174013.94413.99
432853-3285314.43314.48
531836-3183613.98614.03
631854-3185413.99414.04
30min137250-3725016.36516.391.1516.4416.461.16
237652-3765216.54116.61
337199-3719916.34216.41
437953-3795316.67316.75
536792-3679216.16316.23
636997-3699716.25316.32
45min141932-4193218.42218.381.3118.5218.481.30
242592-4259218.71118.81
341796-4179618.36218.46
442206-4220618.54218.64
541344-4134418.16318.26
641108-4110818.06018.16
60min143961-4396119.31319.501.2919.4419.631.29
245323-4532319.91120.04
344291-4429119.45819.59
444849-4484919.70319.84
543979-4397919.32119.45
643951-4395119.30919.44
极限146422-4642220.39420.420.9920.5620.580.98
247125-4712520.70320.86
346340-4634020.35820.52
446912-4691220.60920.77
546124-4612420.26320.42
645939-4593920.18220.34
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%
115.951865318684186001868618672186590.20
215.861866718721186940.21
单位质量响应值RSD%判断
1169.841178.690.54数据可信
供试品溶液-2024080421批-20mg2.5mg-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%
5min116418-1641888.27889.552.2588.2889.552.25
216876-1687690.74090.74
317032-1703291.57991.58
416117-1611786.65986.66
517014-1701491.48291.48
616472-1647288.56888.57
10min117665-1766594.98393.882.3795.1394.032.36
217545-1754594.33794.49
316807-1680790.36990.52
417397-1739793.54293.69
518048-1804897.04297.19
617299-1729993.01593.16
15min117537-1753794.29494.451.0994.6094.751.09
217615-1761594.71495.02
317731-1773195.33795.64
417206-1720692.51592.81
517707-1770795.20895.52
617595-1759594.60694.91
20min117776-1777695.57995.331.1596.0495.791.15
217739-1773995.38095.85
317769-1776995.54296.00
417571-1757194.47794.93
518055-1805597.08097.55
617463-1746393.89694.36
30min117258-1725892.79494.021.5293.4294.641.52
217691-1769195.12295.75
317725-1772595.30595.93
417378-1737893.43994.05
517737-1773795.37096.00
617129-1712992.10192.72
45min117514-1751494.17194.891.6794.9595.661.66
217761-1776195.49996.28
317840-1784095.92496.70
417314-1731493.09593.86
518073-1807397.17697.97
617381-1738193.45694.23
60min117917-1791796.33895.431.7997.2796.361.77
217788-1778895.64496.59
318067-1806797.14498.08
417640-1764094.84895.77
517902-1790296.25797.21
617172-1717292.33293.26
极限117795-1779595.68295.051.6496.7896.141.63
217390-1739093.50494.61
317913-1791396.31697.42
417480-1748093.98895.07
518071-1807197.16698.28
617411-1741193.61794.70
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%
110.972289022287822285552284642288832287170.09
211.122293932289802291860.13
单位质量响应值RSD%判断
20849.3220610.250.82数据可信
供试品溶液-2024080421批-20mg2.5mg-坎地沙坦酯-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%
5min113540-135405.8675.894.325.875.904.29
214245-142456.1726.17
314059-140596.0926.09
413968-139686.0526.05
512900-129005.5905.59
612915-129155.5965.60
10min122016-220169.5409.542.129.559.552.11
222445-224459.7269.74
322207-222079.6229.63
422340-223409.6809.69
521882-218829.4829.49
621156-211569.1679.18
15min127908-2790812.09312.021.5412.1212.051.54
228053-2805312.15512.18
327846-2784612.06612.09
428116-2811612.18312.21
527574-2757411.94811.97
626963-2696311.68311.71
20min131859-3185913.80513.831.1613.8513.881.15
232111-3211113.91413.96
331928-3192813.83513.88
432299-3229913.99514.04
532075-3207513.89813.94
631231-3123113.53313.58
30min137217-3721716.12616.111.3016.2016.181.32
237493-3749316.24616.32
337283-3728316.15516.22
437662-3766216.31916.39
537194-3719416.11616.18
636275-3627515.71815.78
45min142253-4225318.30818.201.0418.4018.291.05
241981-4198118.19118.29
341921-4192118.16518.26
442340-4234018.34618.44
542281-4228118.32118.42
641171-4117117.84017.93
60min144597-4459719.32419.321.2919.4519.441.30
244731-4473119.38219.51
344690-4469019.36419.49
445007-4500719.50219.63
544988-4498819.49319.62
643460-4346018.83118.95
极限146829-4682920.29120.141.0420.4520.301.04
246543-4654320.16720.33
346718-4671820.24320.40
446811-4681120.28320.44
546445-4644520.12520.28
645550-4555019.73719.89
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