贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.459710369733009725939724529723199723400.09
211.419749309762739756020.10
单位质量响应值RSD%判断
84920.5285504.120.49数据可信
供试品溶液-24052301批-贝派度酸-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148987-489875.1574.2125.355.164.2125.31
245237-452374.7624.76
327458-274582.8912.89
430741-307413.2363.24
551909-519095.4655.46
635517-355173.7393.74
10min168912-689127.2547.243.867.317.293.97
269372-693727.3037.36
366883-668837.0417.07
464928-649286.8356.87
572561-725617.6397.70
670209-702097.3917.43
15min171486-714867.5257.721.847.667.841.84
273400-734007.7277.86
374330-743307.8257.94
471805-718057.5597.67
574649-746497.8588.00
674058-740587.7967.92
20min168992-689927.2637.432.087.487.641.95
268627-686277.2247.44
372129-721297.5937.79
470790-707907.4527.65
570854-708547.4597.69
671945-719457.5747.78
30min170665-706657.4398.4211.047.748.7110.67
270823-708237.4567.76
374979-749797.8938.17
485437-854378.9949.27
587677-876779.2309.55
690228-902289.4989.79
45min173890-738907.7789.2813.878.169.6713.25
277438-774388.1528.54
397046-9704610.21610.59
4104994-10499411.05311.43
582007-820078.6339.05
693416-934169.83410.23
60min196265-9626510.13410.532.8110.6111.022.65
2104053-10405310.95411.43
3101288-10128810.66311.15
4100063-10006310.53411.04
597420-9742010.25610.77
6100805-10080510.61211.12
极限1185883-18588319.56815.1321.7720.1515.7420.87
2122826-12282612.93013.53
3129990-12999013.68414.29
4157199-15719916.54917.17
5165719-16571917.44518.07
6101001-10100110.63211.26
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180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%
110.262605582601572600692599532596962600870.13
210.272613492615042614260.05
单位质量响应值RSD%判断
25349.6125455.310.30数据可信
供试品溶液-24052301批-依折麦布-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min197795-9779538.39129.5232.1138.3929.5232.11
282565-8256532.41232.41
346877-4687718.40218.40
457105-5710522.41722.42
5106677-10667741.87741.88
660105-6010523.59523.59
10min1179852-17985270.60362.5613.4471.0362.8813.52
2169092-16909266.37966.74
3136367-13636753.53353.74
4131293-13129351.54151.79
5180819-18081970.98371.45
6158691-15869162.29662.56
15min1199924-19992478.48375.845.8479.6976.865.98
2197175-19717577.40378.50
3184912-18491272.58973.39
4174288-17428868.41969.24
5203942-20394280.06081.31
6198912-19891278.08579.04
20min1208052-20805281.67379.734.5883.7681.604.70
2201255-20125579.00580.96
3198869-19886978.06879.67
4187444-18744473.58375.17
5211418-21141882.99585.14
6211604-21160483.06884.89
30min1221309-22130986.87886.663.0989.8789.423.15
2221224-22122486.84489.68
3221217-22121786.84189.31
4208964-20896482.03184.43
5221522-22152286.96190.03
6230341-23034190.42393.17
45min1231242-23124290.77791.612.4094.7395.332.47
2232344-23234491.20995.01
3233144-23314491.52494.96
4225024-22502488.33691.65
5236818-23681892.96697.00
6241645-24164594.86198.61
60min1234995-23499592.25093.562.3997.2198.292.34
2234003-23400391.86196.67
3242368-24236895.14499.60
4232324-23232491.20295.49
5239087-23908793.85798.92
6247199-24719997.041101.84
极限1235074-23507492.28194.922.1098.27100.691.93
2244683-24468396.053101.89
3246086-24608696.604102.12
4239101-23910193.86299.17
5238067-23806793.45699.56
6247695-24769597.236103.12
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