二甲双胍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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.109742897318969689746996711971790.34
210.149638496253963180.10
单位质量响应值RSD%判断
9621.689498.820.91数据可信
供试品溶液-2024112921批-恩格列净-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min149198-4919846.31740.0616.4946.3240.0716.48
230258-3025828.48628.49
339522-3952237.20737.21
448570-4857045.72645.73
542988-4298840.47040.47
644800-4480042.17642.18
10min187680-8768082.54578.839.9082.6278.909.90
267672-6767263.70963.76
382933-8293378.07678.14
490669-9066985.35985.44
585567-8556780.55680.62
687906-8790682.75882.83
15min199695-9969593.85793.823.2294.0794.013.24
293434-9343487.96288.12
3100348-10034894.47194.66
4102020-10202096.04596.26
5100248-10024894.37794.58
6102161-10216196.17896.39
20min199991-9999194.13595.231.3394.5195.581.34
299261-9926193.44893.75
3101345-10134595.41095.76
4102756-10275696.73897.12
5101198-10119895.27295.63
6102346-10234696.35296.72
30min199732-9973293.89195.391.3094.4295.901.31
299854-9985494.00694.46
3101253-10125395.32395.83
4102921-10292196.89497.43
5101812-10181295.85096.37
6102374-10237496.37996.91
45min199783-9978393.93995.271.1594.6295.941.17
299949-9994994.09694.71
3101229-10122995.30195.97
4102470-10247096.46997.17
5101317-10131795.38496.06
6102449-10244996.44997.14
60min1100063-10006394.20395.001.0395.0495.831.05
299722-9972293.88294.65
3100269-10026994.39795.22
4102107-10210796.12796.99
5101292-10129295.36096.20
6102017-10201796.04396.89
极限199340-9934093.52295.251.3994.5296.241.39
2100093-10009394.23195.16
3100618-10061894.72595.71
4101892-10189295.92596.95
5102012-10201296.03897.03
6103110-10311097.07298.08
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.101027585102693910297171026976102828010278990.12
210.031020102102014110201220.01
单位质量响应值RSD%判断
101772.18101707.080.05数据可信
供试品溶液-2024112921批-二甲双胍-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1603625-60362553.39747.0114.3353.4047.0114.34
2397737-39773735.18435.18
3496419-49641943.91443.91
4593839-59383952.53252.53
5538299-53829947.61947.62
6558525-55852549.40849.41
10min1982060-98206086.87483.548.3486.9683.628.34
2792033-79203370.06470.12
3935568-93556882.76182.83
41010430-101043089.38489.47
5962082-96208285.10785.19
6984155-98415587.05987.14
15min11089056-108905696.33996.342.5896.5796.562.59
21034811-103481191.54191.72
31093678-109367896.74896.96
41112825-111282598.44298.68
51096265-109626596.97797.20
61107557-110755797.97698.20
20min11090755-109075596.48997.501.1796.8897.871.19
21085780-108578096.04996.38
31096435-109643596.99297.36
41116989-111698998.81099.21
51110078-111007898.19998.58
61112778-111277898.43898.83
30min11088765-108876596.31397.521.1296.8798.061.12
21090281-109028196.44796.94
31096136-109613696.96597.50
41117883-111788398.88999.45
51111221-111122198.30098.85
61110197-111019798.20998.76
45min11088571-108857196.29697.331.0197.0198.031.02
21089610-108961096.38897.04
31093130-109313096.69997.40
41113426-111342698.49599.22
51106133-110613397.85098.56
61110400-111040098.22798.95
60min11086114-108611496.07997.111.0896.9697.981.08
21086675-108667596.12896.94
31088726-108872696.31097.17
41111220-111122098.30099.19
51106367-110636797.87098.74
61107601-110760197.98098.86
极限11083852-108385295.87996.961.1196.9297.991.12
21084923-108492395.97396.94
31086882-108688296.14797.16
41110186-111018698.20899.27
51104730-110473097.72698.76
61106122-110612297.84998.89
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