氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)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%
115.479889298887987799872198614987790.12
215.509832698534984300.15
单位质量响应值RSD%判断
6385.206350.320.39数据可信
供试品溶液-24070201批-氨氯地平-pH2.0的盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165034-6503466.20664.082.7966.2164.082.79
263493-6349364.63864.64
364013-6401365.16765.17
463324-6332464.46664.47
561615-6161562.72662.73
660179-6017961.26461.26
10min183603-8360385.11082.304.0585.2282.414.05
280691-8069182.14682.25
385919-8591987.46887.58
478482-7848279.89780.00
578685-7868580.10480.21
677694-7769479.09579.20
15min193305-9330594.98791.193.6495.2491.433.64
287901-8790189.48689.73
394143-9414395.84096.09
487299-8729988.87389.11
588022-8802289.60989.85
686755-8675588.31988.55
20min196568-9656898.30994.773.5798.7295.163.57
290595-9059592.22892.62
397811-9781199.57499.99
490453-9045392.08492.47
592743-9274394.41594.80
690369-9036991.99892.38
30min199040-99040100.82697.183.17101.4097.743.17
292002-9200293.66194.21
399110-99110100.897101.48
492958-9295894.63495.18
594346-9434696.04796.59
695308-9530897.02697.56
45min1102525-102525104.37399.573.65105.12100.293.65
295250-9525096.96797.67
3102107-102107103.948104.70
494772-9477296.48197.18
596903-9690398.65099.35
695295-9529597.01397.71
极限1100588-100588102.40195.136.66103.3296.016.63
294774-9477496.48397.35
3100773-100773102.590103.51
486894-8689488.46189.32
589443-8944391.05691.92
688170-8817089.76090.62
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.583667503667903666903667683664143666820.05
211.663685543688613687080.06
单位质量响应值RSD%判断
31665.1131621.610.10数据可信
供试品溶液-24070201批-阿托伐他汀钙-pH2.0的盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144886-4488611.71712.916.1911.7212.916.17
252386-5238613.67513.67
347541-4754112.41012.41
452192-5219213.62413.62
551554-5155413.45713.46
648141-4814112.56612.57
10min180253-8025320.94923.197.7920.9723.217.78
299024-9902425.84925.87
390785-9078523.69823.72
493619-9361924.43824.46
584041-8404121.93821.96
685355-8535522.28122.30
15min1116391-11639130.38232.776.4330.4432.836.42
2135799-13579935.44835.51
3127576-12757633.30233.36
4133010-13301034.72034.78
5117024-11702430.54730.61
6123501-12350132.23832.30
20min1143569-14356937.47640.195.0537.5840.305.06
2161262-16126242.09542.22
3156121-15612140.75340.87
4162833-16283342.50542.63
5146390-14639038.21338.32
6153549-15354940.08240.19
30min1177599-17759946.35949.044.0646.5349.224.06
2189629-18962949.50049.69
3190726-19072649.78649.97
4199587-19958752.09952.29
5181859-18185947.47147.65
6187730-18773049.00449.18
45min1204054-20405453.26556.094.4753.5156.354.47
2209552-20955254.70054.98
3218646-21864657.07457.34
4231759-23175960.49760.78
5211001-21100155.07955.33
6214218-21421855.91856.18
极限1224267-22426758.54160.953.1858.8761.313.18
2233166-23316660.86461.23
3234700-23470061.26561.63
4245865-24586564.17964.56
5227872-22787259.48259.83
6235145-23514561.38161.73
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)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%
115.479881798860989379893899011989130.08
215.509888999059989740.13
单位质量响应值RSD%判断
6393.866385.420.10数据可信
供试品溶液-24070201批-氨氯地平-醋酸盐缓冲液(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%
5min174811-7481175.89879.026.0875.9079.026.08
284749-8474985.98185.98
373045-7304574.10774.11
481611-8161182.79782.80
579244-7924480.39680.40
673862-7386274.93674.94
10min184572-8457285.80189.124.9785.9389.264.97
292962-9296294.31394.46
385385-8538586.62686.75
492134-9213493.47393.61
589699-8969991.00391.14
682335-8233583.53283.66
15min188927-8892790.22093.714.4490.4993.994.44
296165-9616597.56397.86
390510-9051091.82692.09
496916-9691698.32598.62
594651-9465196.02796.31
687047-8704788.31288.58
20min189830-8983091.13695.144.5591.5695.584.55
296409-9640997.81098.27
393007-9300794.35994.78
499005-99005100.444100.90
596434-9643497.83698.28
687993-8799389.27289.68
30min191237-9123792.56396.434.5093.1397.024.50
297830-9783099.25299.88
394419-9441995.79196.37
499964-99964101.417102.04
597818-9781899.24099.85
688996-8899690.29090.85
45min192646-9264693.99396.904.2894.7297.654.28
297905-9790599.328100.12
395259-9525996.64497.38
4100307-100307101.765102.56
597829-9782999.251100.03
689109-8910990.40491.11
极限193231-9323194.58697.114.1795.4798.024.18
297715-9771599.135100.09
395466-9546696.85497.75
4100398-100398101.857102.82
598204-9820499.631100.57
689291-8929190.58991.45
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.583690503690793692343692803696463692580.07
211.663716293719673717980.07
单位质量响应值RSD%判断
31887.5631886.620.01数据可信
供试品溶液-24070201批-阿托伐他汀钙-醋酸盐缓冲液(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%
5min1139660-13966036.17736.063.4136.1836.063.41
2146825-14682538.03338.03
3133624-13362434.61434.61
4136323-13632335.31335.31
5136668-13666835.40235.40
6142116-14211636.81436.81
10min1217279-21727956.28456.351.5456.3456.401.54
2222023-22202357.51357.58
3214432-21443255.54655.60
4213804-21380455.38455.44
5216737-21673756.14356.20
6220854-22085457.21057.27
15min1258409-25840966.93867.601.1967.0967.751.19
2263064-26306468.14468.30
3259609-25960967.24967.40
4257393-25739366.67566.83
5261621-26162167.77067.92
6265672-26567268.81968.98
20min1280019-28001972.53674.251.3172.8074.521.31
2287426-28742674.45574.73
3287115-28711574.37474.64
4286263-28626374.15374.42
5287465-28746574.46574.73
6291597-29159775.53575.81
30min1300768-30076877.91181.152.0578.3081.542.04
2316063-31606381.87382.27
3313955-31395581.32781.71
4318196-31819682.42582.81
5313220-31322081.13681.53
6317349-31734982.20682.60
45min1316208-31620881.91085.082.0382.4385.602.02
2328855-32885585.18685.72
3330652-33065285.65286.17
4334834-33483486.73587.26
5326782-32678284.64985.17
6333290-33329086.33586.87
极限1341988-34198888.58890.061.7589.2490.721.74
2343835-34383589.06789.74
3355014-35501491.96292.63
4343876-34387689.07789.75
5345524-34552489.50490.17
6355668-35566892.13292.81
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)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%
115.479903399117991719921399174991420.08
215.509965199761997060.08
单位质量响应值RSD%判断
6408.666432.650.27数据可信
供试品溶液-24070201批-氨氯地平-磷酸盐缓冲液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150429-5042950.91545.1815.5550.9245.1815.55
249995-4999550.47750.48
339294-3929439.67339.67
434755-3475535.09035.09
551612-5161252.10952.11
642424-4242442.83342.83
10min173214-7321473.92067.9110.5374.0067.9910.53
268728-6872869.39069.47
361814-6181462.41062.48
456068-5606856.60856.67
574635-7463575.35475.44
669128-6912869.79469.87
15min182071-8207182.86281.324.7383.0781.514.74
282799-8279983.59783.80
376895-7689577.63677.81
475101-7510175.82575.98
585179-8517986.00086.21
681209-8120981.99282.18
20min186941-8694187.77987.003.0188.1387.333.03
287214-8721488.05588.39
384220-8422085.03285.33
482111-8211182.90283.18
589426-8942690.28890.64
687124-8712487.96488.29
30min189199-8919990.05990.981.5290.5591.451.54
289732-8973290.59791.08
390606-9060691.47991.92
488813-8881389.66990.09
592618-9261893.51194.02
689683-8968390.54791.02
45min190333-9033391.20492.641.3391.8593.261.32
290866-9086691.74292.38
393121-9312194.01894.61
491632-9163292.51593.08
593331-9333194.23094.89
691265-9126592.14592.77
极限192644-9264493.53796.872.3294.3397.652.31
295911-9591196.83597.63
398313-9831399.261100.01
494220-9422095.12895.85
598197-9819799.14399.96
696395-9639597.32498.10
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.583696403697053697083699793699803698020.05
211.663724623726963725790.05
单位质量响应值RSD%判断
31934.5431953.600.05数据可信
供试品溶液-24070201批-阿托伐他汀钙-磷酸盐缓冲液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193910-19391050.14141.8716.1050.1441.8616.10
2177745-17774545.96145.96
3139698-13969836.12336.12
4127173-12717332.88432.88
5180206-18020646.59746.60
6152707-15270739.48739.49
10min1278409-27840971.99062.1711.9872.0762.2411.98
2253180-25318065.46765.54
3206941-20694153.51053.57
4206446-20644653.38253.44
5256722-25672266.38266.46
6240819-24081962.27062.34
15min1314829-31482981.40873.387.2581.6173.557.26
2290432-29043275.09975.28
3252299-25229965.23965.39
4275129-27512971.14271.29
5289314-28931474.81075.00
6280605-28060572.55872.73
20min1328237-32823784.87578.445.4285.2178.735.43
2304668-30466878.78079.09
3276827-27682771.58171.84
4306511-30651179.25779.52
5304055-30405578.62278.93
6299707-29970777.49777.79
30min1339648-33964887.82582.604.3088.3183.034.30
2315784-31578481.65482.10
3301148-30114877.87078.25
4330945-33094585.57585.97
5316000-31600081.71082.15
6313161-31316180.97681.40
45min1352534-35253491.15784.544.9091.7885.104.90
2320056-32005682.75983.34
3310645-31064580.32680.83
4340491-34049188.04388.58
5319378-31937882.58483.16
6318507-31850782.35982.91
极限1385347-38534799.64295.642.25100.4296.352.27
2366799-36679994.84695.56
3360463-36046393.20793.85
4370343-37034395.76296.45
5368700-36870095.33796.06
6367603-36760395.05495.75
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