比索洛尔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100711-202203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2000
标示量(mg)5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%
110.388411784145840638396183953840480.11
210.458411784203841600.08
单位质量响应值RSD%判断
8097.118053.590.39数据可信
工艺验证-工艺验证-供试品溶液-G01RY4批-5mg规格-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%
5min171284-7128479.28868.3719.9679.2968.3619.97
265499-6549972.85372.85
369838-6983877.68077.68
450747-5074756.44556.44
569650-6965077.47077.47
641774-4177446.46446.46
10min181631-8163190.79781.9413.9190.9382.0513.91
275438-7543883.90884.03
380936-8093690.02490.15
467053-6705374.58274.68
580858-8085889.93790.07
656076-5607662.37262.45
15min184740-8474094.25586.9711.2294.5487.2211.24
278601-7860187.42687.69
383884-8388493.30393.58
473796-7379682.08282.30
585354-8535494.93895.22
662752-6275269.79869.98
20min186604-8660496.32889.919.7396.7790.309.75
280478-8047889.51489.92
385837-8583795.47595.91
477589-7758986.30186.66
587585-8758597.41997.86
666890-6689074.40174.70
30min188767-8876798.73493.377.5199.3493.927.54
282882-8288292.18892.74
387887-8788797.75598.35
482155-8215591.38091.88
589290-8929099.31699.92
672690-7269080.85281.27
45min190072-90072100.18596.065.55100.9596.765.59
284459-8445993.94294.65
389393-8939399.430100.19
485704-8570495.32795.98
590550-90550100.717101.48
677986-7798686.74287.30
极限191080-91080101.307100.361.85102.24101.221.86
287375-8737597.18698.05
391825-91825102.135103.06
489173-8917399.186100.00
591314-91314101.567102.50
690627-90627100.803101.50
比索洛尔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100711-202203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2000
标示量(mg)5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%
110.388413284175841878413684124841510.04
210.458411484140841270.03
单位质量响应值RSD%判断
8107.038050.430.50数据可信
工艺验证-工艺验证-供试品溶液-G01RY4批-5mg规格-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%
5min171782-7178279.80964.7224.6179.8164.7224.61
266473-6647373.90673.91
335374-3537439.33039.33
470273-7027378.13178.13
547943-4794353.30453.30
657406-5740663.82563.83
10min182062-8206291.23876.5118.9591.3776.6218.96
275158-7515883.56283.69
347172-4717252.44752.51
478556-7855687.34087.47
560446-6044667.20567.29
669482-6948277.25277.36
15min186529-8652996.20582.9014.5196.4983.1314.53
278833-7883387.64887.91
357037-5703763.41563.57
482313-8231391.51791.79
567113-6711374.61874.82
675535-7553583.98184.22
20min188666-8866698.58186.3212.1399.0386.6912.16
281292-8129290.38290.79
362501-6250169.49069.75
483894-8389493.27593.70
571326-7132679.30279.63
678131-7813186.86887.24
30min191143-91143101.33590.449.59101.9490.969.62
284752-8475294.22994.79
369132-6913276.86277.24
486026-8602695.64696.23
576406-7640684.95085.41
680585-8058589.59690.12
45min192674-92674103.03794.106.93103.8294.766.99
287518-8751897.30498.02
376380-7638084.92185.42
487983-8798397.82198.56
580759-8075989.79090.39
682481-8248191.70492.37
极限193607-93607104.074100.163.52105.02100.983.52
290882-90882101.045101.92
390327-90327100.428101.07
490375-90375100.481101.39
591196-91196101.394102.14
684104-8410493.50994.33
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