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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
111.159676139693979675229676489673209679000.09
211.179696949695989696460.01
单位质量响应值RSD%判断
86807.1786808.060.01数据可信
供试品溶液-2024092721批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1175729-17572918.17424.2625.3418.1724.2625.35
2281543-28154329.11729.12
3202900-20290020.98420.98
4331102-33110234.24234.24
5220290-22029022.78222.78
6196183-19618320.28920.29
10min1453388-45338846.88962.9719.7947.0963.2319.82
2730170-73017075.51375.84
3561994-56199458.12058.35
4774566-77456680.10480.48
5581319-58131960.11960.37
6551620-55162057.04857.27
15min1681214-68121470.45085.7611.8271.1786.7311.92
2935520-93552096.75097.91
3820638-82063884.86985.75
4937969-93796997.00398.27
5824888-82488885.30986.23
6775504-77550480.20181.06
20min1800433-80043382.77993.826.8184.2995.746.95
2961515-96151599.438101.68
3937226-93722696.92698.75
4951118-95111898.363100.71
5924942-92494295.65697.52
6867963-86796389.76391.51
30min1836774-83677486.53894.354.3088.9697.314.50
2941749-94174997.394100.74
3936288-93628896.82999.73
4931850-93185096.37099.81
5922083-92208395.36098.29
6905057-90505793.59996.35
45min1873039-87303990.28894.952.5193.6898.972.74
2938798-93879897.089101.51
3928612-92861296.036100.01
4922709-92270995.42599.94
5920765-92076595.22499.22
6925000-92500095.66299.45
60min1895306-89530692.59194.140.9596.9899.201.21
2918383-91838394.978100.48
3912031-91203194.32199.36
4905429-90542993.63899.21
5917124-91712494.84799.90
6913214-91321494.44399.29
极限1914727-91472794.60094.681.05100.02100.790.80
2906195-90619593.717100.28
3918221-91822194.961101.05
4903333-90333393.421100.03
5921700-92170095.321101.42
6928754-92875496.050101.95
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%
110.162580552583592584232583082581552582600.06
210.192587602590572589080.09
单位质量响应值RSD%判断
25419.2925408.050.04数据可信
供试品溶液-2024092721批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122481-224818.82113.7227.218.8213.7227.21
243525-4352517.07917.08
331710-3171012.44312.44
448421-4842119.00019.00
534142-3414213.39713.40
629437-2943711.55111.55
10min173185-7318528.71737.6418.9828.8137.7919.01
2113717-11371744.62144.81
388831-8883134.85634.99
4121135-12113547.53247.74
594371-9437137.03037.18
684330-8433033.09033.22
15min1117829-11782946.23555.8111.7146.6556.3811.81
2157865-15786561.94462.63
3139082-13908254.57455.10
4162462-16246263.74864.49
5144885-14488556.85157.41
6131246-13124651.49952.00
20min1157319-15731961.73066.735.7162.6667.925.88
2177779-17777969.75871.13
3171118-17111867.14568.28
4180543-18054370.84372.29
5174449-17444968.45269.64
6159167-15916762.45563.52
30min1175094-17509468.70574.284.1470.3276.214.29
2191161-19116175.00977.16
3193959-19395976.10777.99
4195183-19518376.58778.82
5194873-19487376.46678.42
6185501-18550172.78874.55
45min1200235-20023578.57082.673.7680.9585.433.77
2206328-20632880.96083.94
3212406-21240683.34586.07
4211895-21189583.14586.23
5224032-22403287.90790.71
6209250-20925082.10784.68
60min1219726-21972686.21885.942.1589.4789.622.00
2210862-21086282.74086.62
3220262-22026286.42890.08
4218401-21840185.69889.71
5225399-22539988.44492.22
6219513-21951386.13489.62
极限1227353-22735389.21089.713.1493.4294.342.97
2215764-21576484.66389.46
3230755-23075590.54595.16
4228913-22891389.82394.78
5237400-23740093.15397.91
6231589-23158990.87395.31
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