贝派度酸片项目信息
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对照品来源自制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50
标示量(mg)180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%
19.923047173045043043013043243042793044250.07
29.873039943040793040360.02
单位质量响应值RSD%判断
30688.0030804.050.27数据可信
供试品溶液-24052801批-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%
5min1109762-10976235.60035.163.0435.6035.163.04
2105207-10520734.12234.12
3114065-11406536.99537.00
4106773-10677334.63034.63
5105760-10576034.30234.30
6108909-10890935.32335.32
10min1226710-22671073.53073.810.9873.9374.200.96
2228911-22891174.24474.62
3224851-22485172.92773.34
4229476-22947674.42774.81
5225414-22541473.11073.49
6230064-23006474.61875.01
15min1248966-24896680.74981.251.1081.9682.461.08
2251442-25144281.55282.76
3246856-24685680.06481.29
4252384-25238481.85783.07
5249018-24901880.76581.96
6254404-25440482.51283.73
20min1258091-25809183.70884.271.1685.8286.381.15
2261452-26145284.79886.91
3256454-25645483.17785.29
4262031-26203184.98687.11
5257074-25707483.37885.47
6263793-26379385.55787.70
30min1268055-26805586.94087.891.3489.9890.941.32
2273198-27319888.60891.66
3268110-26811086.95889.99
4273884-27388488.83091.90
5267170-26717086.65389.67
6275563-27556389.37592.46
45min1274848-27484889.14390.731.6693.1594.751.63
2282783-28278391.71795.75
3277851-27785190.11794.12
4283530-28353091.95996.01
5274367-27436788.98792.97
6284999-28499992.43596.52
60min1276535-27653589.69091.561.8494.6996.601.80
2285422-28542292.57397.63
3281379-28137991.26196.26
4286388-28638892.88697.96
5275981-27598189.51094.48
6288159-28815993.46098.57
极限1279059-27905990.50992.572.0896.5098.622.02
2287989-28798993.40599.49
3285171-28517192.49198.51
4291235-29123594.458100.56
5277685-27768590.06396.03
6291341-29134194.492100.64
贝派度酸片项目信息
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对照品来源自制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50
标示量(mg)180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%
19.923035283036653036533036633036943036410.03
29.873038493040633039560.05
单位质量响应值RSD%判断
30608.9730795.950.44数据可信
供试品溶液-24052801批-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min130635-306359.95011.328.829.9511.328.82
237124-3712412.05812.06
331936-3193610.37310.37
437321-3732112.12212.12
537913-3791312.31412.31
634262-3426211.12811.13
10min176221-7622124.75625.082.8324.8725.202.85
278516-7851625.50225.64
375394-7539424.48824.60
480389-8038926.11026.24
578147-7814725.38225.52
674587-7458724.22624.35
15min189737-8973729.14629.991.6029.5330.391.59
292403-9240330.01230.43
393032-9303230.21730.60
492650-9265030.09330.52
592005-9200529.88330.30
694178-9417830.58930.98
20min197918-9791831.80432.651.6532.5133.391.66
2101690-10169033.02933.78
399462-9946232.30533.03
4102496-10249633.29034.05
5100464-10046432.63033.38
6101184-10118432.86433.60
30min1106360-10636034.54535.721.7235.6136.821.72
2110250-11025035.80936.93
3110491-11049135.88736.97
4111837-11183736.32437.45
5110923-11092336.02837.14
6110060-11006035.74736.85
45min1112481-11248136.53438.802.9437.9840.302.90
2120336-12033639.08540.60
3120131-12013139.01840.50
4121146-12114639.34840.88
5122235-12223539.70241.22
6120460-12046039.12540.62
60min1115800-11580037.61240.113.1139.4642.043.06
2125530-12553040.77242.72
3125040-12504040.61342.53
4125752-12575240.84442.81
5125060-12506040.61942.57
6123757-12375740.19642.13
极限1123016-12301639.95541.872.8942.2344.242.83
2131445-13144542.69345.10
3131266-13126642.63545.00
4129702-12970242.12744.55
5132310-13231042.97445.38
6125711-12571140.83143.21
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