苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018991790075898328958889340897500.33
214.058936689546894560.15
单位质量响应值RSD%判断
6406.146366.980.44数据可信
长期24月-供试品溶液-2022032901批-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%
5min168815-6881575.60177.247.5575.6077.247.55
265918-6591872.41972.42
362775-6277568.96668.97
473594-7359480.85180.85
575746-7574683.21683.22
675014-7501482.41282.41
10min177780-7778085.45087.392.8586.2188.162.86
282660-8266090.81291.54
376193-7619383.70784.40
479812-7981287.68388.49
580534-8053488.47689.31
680301-8030188.22089.04
15min179924-7992487.80687.960.7289.4289.610.68
280792-8079288.75990.39
380099-8009987.99889.52
480656-8065688.61090.30
579400-7940087.23088.95
679539-7953987.38389.09
20min179582-7958287.43087.661.3689.9290.191.39
280030-8003087.92290.44
377730-7773085.39587.80
480502-8050288.44191.01
580279-8027988.19690.78
680643-8064388.59691.18
30min178576-7857686.32586.462.2489.6989.862.10
279366-7936687.19390.59
380460-8046088.39591.66
480400-8040088.32991.78
577360-7736084.98988.46
676024-7602483.52186.99
45min179650-7965087.50587.561.5091.7391.821.42
280679-8067988.63592.91
379740-7974087.60491.75
478702-7870286.46390.80
578099-7809985.80190.12
681319-8131989.33893.64
60min178941-7894186.72684.932.1691.8390.082.09
278108-7810885.81190.97
374120-7412081.42986.45
477296-7729684.91990.12
577488-7748885.13090.31
677909-7790985.59290.79
极限178768-7876886.53685.091.9692.5091.081.86
278503-7850386.24592.26
376137-7613783.64589.48
478337-7833786.06292.12
575035-7503582.43588.46
677931-7793185.61691.67
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018910988775889458911889031889960.16
214.058905488903889780.12
单位质量响应值RSD%判断
6352.326332.950.22数据可信
长期24月-供试品溶液-2022033001批-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%
5min147323-4732352.34966.2614.9452.3566.2614.94
264170-6417070.98670.99
354889-5488960.71960.72
472448-7244880.14380.14
555770-5577061.69461.69
664814-6481471.69871.70
10min181267-8126789.89989.431.2590.4290.091.21
279629-7962988.08788.80
381630-8163090.30090.91
480094-8009488.60189.40
580244-8024488.76789.38
682205-8220590.93691.65
15min179226-7922687.64189.332.3389.0690.882.30
282681-8268191.46393.05
378979-7897987.36888.88
479299-7929987.72289.41
583243-8324392.08593.59
681062-8106289.67291.30
20min178170-7817086.47386.793.5588.7789.243.41
274664-7466482.59485.10
380330-8033088.86291.25
475653-7565383.68886.25
580700-8070089.27291.70
681233-8123389.86192.38
30min178759-7875987.12486.571.2690.2989.891.20
276928-7692885.09988.43
379324-7932487.74991.02
477587-7758785.82889.23
577709-7770985.96389.28
679231-7923187.64791.07
45min181031-8103189.63888.662.8993.6792.842.69
281386-8138690.03094.21
381516-8151690.17494.32
476370-7637084.48288.74
582319-8231991.06395.24
678280-7828086.59590.89
60min179637-7963788.09686.872.4293.0391.942.25
280719-8071989.29394.38
378717-7871787.07892.13
476565-7656584.69789.80
579646-7964688.10693.19
675905-7590583.96789.13
极限177236-7723685.44086.222.4691.2592.162.31
278008-7800886.29492.27
376920-7692085.09091.01
479439-7943987.87793.83
580706-8070689.27895.25
675323-7532383.32389.33
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.018921889191895318909589106892280.20
214.058945389592895220.11
单位质量响应值RSD%判断
6368.886371.670.04数据可信
长期24月-供试品溶液-2022033101批-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%
5min153767-5376759.22067.4411.2459.2267.4411.23
257662-5766263.51063.51
360322-6032266.43966.44
456987-5698762.76662.77
566253-6625372.97272.97
672365-7236579.70479.70
10min183248-8324891.69091.232.4492.2891.902.47
279745-7974587.83288.47
381810-8181090.10790.77
483215-8321591.65492.28
583062-8306291.48692.22
685887-8588794.59795.39
15min185796-8579694.49791.533.1896.0193.123.16
281363-8136389.61491.13
384119-8411992.65094.22
480765-8076588.95690.50
580289-8028988.43190.08
686300-8630095.05296.79
20min183555-8355592.02990.631.3194.4893.131.27
281794-8179490.08992.50
380613-8061388.78891.28
482439-8243990.79993.23
583286-8328691.73294.26
682007-8200790.32493.02
30min184693-8469393.28290.062.7696.6693.472.72
278881-7888186.88190.19
381237-8123789.47592.86
479652-7965287.73091.07
583448-8344891.91195.36
682706-8270691.09394.69
45min181174-8117489.40688.751.0793.7193.061.08
279747-7974787.83492.01
379725-7972587.81092.08
481408-8140889.66493.88
579954-7995488.06292.43
681482-8148289.74594.25
60min184146-8414692.67990.481.3497.8895.681.29
281079-8107989.30194.36
381383-8138389.63694.79
482503-8250390.87095.99
581818-8181890.11595.36
681982-8198290.29695.70
极限181494-8149489.75987.191.9995.8993.291.80
279502-7950287.56593.52
380085-8008588.20794.26
478945-7894586.95192.98
577724-7772485.60691.75
677223-7722385.05491.36
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.019039790241905449053590736904910.21
214.058896988854889120.10
单位质量响应值RSD%判断
6459.036328.261.45数据可信
长期24月-供试品溶液-FA2515批-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%
5min161649-6164967.66068.512.4067.6668.512.40
261128-6112867.08867.09
362665-6266568.77568.77
463015-6301569.15969.16
561088-6108867.04467.04
665017-6501771.35671.36
10min169003-6900375.73177.822.3576.4178.502.33
272501-7250179.57080.24
372686-7268679.77380.46
471682-7168278.67179.36
568949-6894975.67276.34
670617-7061777.50278.22
15min172511-7251179.58181.413.9881.0182.883.91
278204-7820485.82987.30
376091-7609183.51085.00
475227-7522782.56284.04
573182-7318280.31781.74
669860-6986076.67278.16
20min171855-7185578.86182.502.6581.0984.782.60
277671-7767185.24487.57
374732-7473282.01984.34
474952-7495282.26084.56
576681-7668184.15886.39
675151-7515182.47884.73
30min172974-7297480.08981.663.4283.1184.763.35
276584-7658484.05187.23
377050-7705084.56387.70
475597-7559782.96886.09
570304-7030477.15980.23
673901-7390181.10784.19
45min169946-6994676.76679.885.1680.5983.804.96
276390-7639083.83887.86
373239-7323980.38084.37
475017-7501782.33186.29
575402-7540282.75486.60
666683-6668373.18577.08
60min173337-7333780.48881.441.5785.0786.161.58
275456-7545682.81387.67
375219-7521982.55387.34
473780-7378080.97485.75
574892-7489282.19486.87
672557-7255779.63184.25
极限176722-7672284.20384.143.6089.5989.683.33
271502-7150278.47484.16
377542-7754285.10390.72
479535-7953587.29092.88
578181-7818185.80491.30
676516-7651683.97689.40
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