恩格列净片项目信息
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.292855057285511928549652854069285456028547540.02
210.352863698286351828636080.01
单位质量响应值RSD%判断
277429.93276677.100.20数据可信
每杯投2片--供试品溶液-2024052411批-25mg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%
5min11881247-188124760.49554.947.3360.4954.947.33
21715555-171555555.16755.17
31691827-169182754.40454.40
41806947-180694758.10558.11
51623045-162304552.19252.19
61532204-153220449.27149.27
10min12327703-232770374.85172.812.8774.9572.902.87
22262086-226208672.74172.83
32241483-224148372.07972.17
42317864-231786474.53574.63
52285808-228580873.50473.59
62149859-214985969.13269.21
15min12462565-246256579.18878.192.0479.4178.402.05
22405818-240581877.36377.58
32392979-239297976.95077.16
42478758-247875879.70979.93
52482597-248259779.83280.04
62365741-236574176.07476.27
20min12512363-251236380.78980.071.7781.1580.411.77
22458259-245825979.04979.39
32445961-244596178.65478.99
42530997-253099781.38881.74
52543000-254300081.77482.12
62448570-244857078.73879.06
30min12543753-254375381.79981.471.7582.2981.941.75
22504328-250432880.53181.00
32487632-248763279.99480.46
42580774-258077482.98983.48
52588521-258852183.23883.72
62495770-249577080.25680.71
45min12562998-256299882.41782.281.7983.0582.901.79
22531955-253195581.41982.03
32513161-251316180.81581.42
42603853-260385383.73184.36
52621986-262198684.31484.93
62519012-251901281.00381.59
60min12568086-256808682.58182.742.0183.3583.492.01
22536405-253640581.56282.31
32535856-253585681.54582.28
42612966-261296684.02484.79
52656606-265660685.42886.19
62528102-252810281.29582.02
极限12892984-289298493.02994.942.0393.9395.822.01
22954868-295486895.01995.90
32932131-293213194.28895.16
42923644-292364494.01594.92
53066419-306641998.60699.51
62943746-294374694.66195.52
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