阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302850842854852849992855972854572853240.10
210.332860132858442859280.05
单位质量响应值RSD%判断
27701.3627679.380.06数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119083-190836.1844.4548.556.184.4548.54
28978-89782.9092.91
318444-184445.9775.98
42410-24100.7810.78
517839-178395.7815.78
615633-156335.0665.07
10min186886-8688628.15523.9421.1528.1923.9621.17
277631-7763125.15625.17
361133-6113319.81019.84
449098-4909815.91015.91
589008-8900828.84328.87
679435-7943525.74125.77
15min1140341-14034145.47743.207.8345.6743.357.89
2139965-13996545.35545.51
3128042-12804241.49241.63
4114648-11464837.15137.24
5141764-14176445.93846.13
6135051-13505143.76343.93
20min1165511-16551153.63352.495.0154.0852.885.07
2171238-17123855.48955.90
3159361-15936151.64152.01
4148193-14819348.02248.32
5167457-16745754.26454.71
6160064-16006451.86852.28
30min1188823-18882361.18860.772.6861.9361.462.73
2193907-19390762.83563.55
3187018-18701860.60361.26
4181066-18106658.67459.24
5191673-19167362.11162.86
6182644-18264459.18559.89
45min1202667-20266765.67465.682.3766.7666.702.40
2209123-20912367.76668.83
3203378-20337865.90466.90
4198071-19807164.18465.08
5206313-20631366.85567.95
6196489-19648963.67264.70
60min1208836-20883667.67367.341.9969.1268.731.98
2213027-21302769.03170.47
3209000-20900067.72669.09
4207462-20746267.22868.48
5208126-20812667.44368.91
6200373-20037364.93066.32
极限1233181-23318175.56275.641.1277.3877.401.16
2237895-23789577.08978.91
3232880-23288075.46477.20
4231685-23168575.07776.70
5234467-23446775.97877.82
6230338-23033874.64176.39
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937192171989717757197671662718650.20
214.987214072098721190.05
单位质量响应值RSD%判断
4813.464814.350.02数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119024-1902425.62219.9564.5425.6219.9464.54
220176-2017627.17327.17
3-0.0000.00
419797-1979726.66326.66
524036-2403632.37232.37
65822-58227.8417.84
10min154859-5485973.88569.1511.0774.0369.2611.07
251337-5133769.14169.29
351835-5183569.81269.81
441932-4193256.47456.62
558816-5881679.21479.39
649285-4928566.37766.42
15min163184-6318485.09783.595.2385.6584.085.26
262847-6284784.64385.18
363288-6328885.23785.62
457278-5727877.14277.60
566414-6641489.44790.07
659362-5936279.94980.36
20min165102-6510287.68088.522.9388.7189.482.99
266221-6622189.18790.19
366102-6610289.02789.89
463908-6390886.07286.96
569077-6907793.03394.15
663938-6393886.11286.97
30min166459-6645989.50890.723.0091.0292.183.03
266294-6629489.28590.79
367758-6775891.25792.61
468468-6846892.21393.58
570512-7051294.96696.60
664687-6468787.12188.46
45min167159-6715990.45091.123.1692.4693.073.17
265822-6582288.65090.65
367953-6795391.52093.38
468966-6896692.88494.76
570930-7093095.52997.69
665090-6509087.66489.48
60min166821-6682189.99590.123.4992.5192.583.45
265920-6592088.78291.27
368235-6823591.89994.27
469765-6976593.96096.36
567769-6776991.27293.96
662962-6296284.79887.10
极限169279-6927993.30692.041.9296.3295.011.95
266698-6669889.82992.81
367675-6767591.14594.03
469589-6958993.72396.64
569622-6962293.76796.97
667193-6719390.49693.27
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302863722861732863132861472863852862780.04
210.332849932850702850320.02
单位质量响应值RSD%判断
27793.9827592.640.52数据可信
供试品溶液-2023101221批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13639-36391.1794.9149.881.184.9249.89
218421-184215.9695.97
37971-79712.5832.58
421303-213036.9036.90
522028-220287.1377.14
617645-176455.7175.72
10min156379-5637918.26826.7218.7718.2726.7418.81
292804-9280430.07030.10
373230-7323023.72823.74
497656-9765631.64231.68
592186-9218629.87029.91
682533-8253326.74226.77
15min1126517-12651740.99446.136.2641.1046.306.33
2147960-14796047.94248.14
3138476-13847644.86945.01
4150861-15086148.88249.10
5147508-14750847.79548.00
6142825-14282546.27846.46
20min1154653-15465350.11054.944.6850.4555.374.74
2174195-17419556.44256.91
3167733-16773354.34854.74
4176951-17695157.33557.82
5171042-17104255.42155.89
6172748-17274855.97356.41
30min1184659-18465959.83364.093.6860.4564.833.74
2201205-20120565.19465.97
3196591-19659163.69964.40
4206030-20603066.75767.56
5197240-19724063.90964.69
6201086-20108665.15565.90
45min1203438-20343865.91769.923.2966.8671.023.34
2215641-21564169.87171.01
3216811-21681170.25171.30
4225275-22527572.99374.17
5215208-21520869.73170.87
6218445-21844570.78071.89
60min1217378-21737870.43472.952.5471.7574.442.59
2224653-22465372.79274.32
3225039-22503972.91774.36
4235121-23512176.18377.76
5223612-22361272.45473.98
6225101-22510172.93774.44
极限1233603-23360375.69179.602.8677.4081.482.90
2246702-24670279.93681.87
3247686-24768680.25582.10
4254752-25475282.54484.55
5243149-24314978.78580.71
6248044-24804480.37182.28
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937227972355722997242672176723070.13
214.987185671972719140.12
单位质量响应值RSD%判断
4843.074800.670.63数据可信
供试品溶液-2023101221批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115483-1548320.81932.9627.9420.8232.9627.94
226917-2691736.19336.19
318302-1830224.60924.61
424352-2435232.74432.74
534484-3448446.36846.37
627549-2754937.04337.04
10min152009-5200969.93274.767.8970.0574.947.92
258525-5852578.69378.89
348559-4855965.29365.43
456569-5656976.06376.25
558084-5808478.10078.36
659831-5983180.44980.66
15min163951-6395185.98987.822.9286.4988.422.97
264965-6496587.35387.99
363079-6307984.81785.32
465264-6526487.75588.36
566047-6604788.80889.50
668566-6856692.19592.85
20min167912-6791291.31590.812.5592.3091.902.55
265492-6549288.06189.18
366806-6680689.82890.80
466972-6697290.05191.14
567420-6742090.65491.84
670636-7063694.97896.14
30min170531-7053194.83794.192.1896.3395.782.12
269060-6906092.85994.47
371472-7147296.10297.57
468742-6874292.43194.02
568428-6842892.00993.70
672058-7205896.89098.58
45min171660-7166096.35593.912.0398.3796.021.98
267955-6795591.37393.50
369643-6964393.64395.65
469164-6916492.99995.10
569255-6925593.12195.32
671368-7136895.96298.19
60min174896-74896100.70694.443.36103.2697.073.23
268815-6881592.52995.17
369575-6957593.55196.08
468865-6886592.59795.22
568960-6896092.72495.44
670285-7028594.50697.27
极限166385-6638589.26292.832.5992.3795.992.56
268324-6832491.86995.02
369374-6937493.28196.32
469484-6948493.42996.57
568781-6878192.48495.72
671871-7187196.63999.93
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