艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.623721213724163722853722813722443722690.03
214.723723123724373723740.03
单位质量响应值RSD%判断
25463.0025297.150.47数据可信
供试品溶液-25112801批-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%
5min1240077-24007765.05366.574.7465.0566.574.74
2241528-24152865.44665.45
3259859-25985970.41370.41
4231586-23158662.75262.75
5241002-24100265.30465.30
6260036-26003670.46170.46
10min1296701-29670180.39681.292.0680.5081.402.06
2299823-29982381.24281.35
3304995-30499582.64482.76
4292600-29260079.28579.39
5296500-29650080.34280.45
6309290-30929083.80883.93
15min1315314-31531485.44085.981.3185.6886.231.32
2316251-31625185.69485.94
3319024-31902486.44586.70
4310855-31085584.23284.47
5319436-31943686.55786.80
6322962-32296287.51287.77
20min1326399-32639988.44488.571.3488.8388.961.34
2324397-32439787.90188.29
3325765-32576588.27288.67
4320900-32090086.95487.33
5331147-33114789.73090.12
6332665-33266590.14190.54
30min1339864-33986492.09291.641.5392.6292.181.53
2334980-33498090.76991.30
3335711-33571190.96791.51
4331242-33124289.75690.28
5345351-34535193.57994.12
6341994-34199492.66993.22
45min1353758-35375895.85794.121.8196.5494.821.80
2343179-34317992.99093.68
3341729-34172992.59893.30
4340767-34076792.33793.01
5354900-35490096.16696.86
6349847-34984794.79795.50
60min1364375-36437598.73496.753.7399.5897.603.70
2348034-34803494.30695.15
3345052-34505293.49894.35
4350126-35012694.87395.70
5380529-380529103.111103.96
6354165-35416595.96796.83
极限1377557-377557102.306100.252.57103.32101.262.55
2369236-369236100.051101.05
3352592-35259295.54196.55
4370563-370563100.411101.39
5370376-370376100.360101.38
6379426-379426102.812103.84
艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.623723603725593724083724093723853724240.03
214.723731573729313730440.05
单位质量响应值RSD%判断
25473.6025342.660.37数据可信
供试品溶液-25112802批-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%
5min1256609-25660969.45670.474.9369.4670.474.93
2273683-27368374.07774.08
3252587-25258768.36768.37
4251928-25192868.18968.19
5279081-27908175.53875.54
6248230-24823067.18867.19
10min1320379-32037986.71684.724.2886.8384.844.28
2320737-32073786.81386.94
3295583-29558380.00580.12
4305784-30578482.76682.88
5331566-33156689.74489.87
6303913-30391382.25982.37
15min1348663-34866394.37290.004.5994.6390.264.59
2335749-33574990.87691.14
3311742-31174284.37884.63
4323954-32395487.68487.94
5350478-35047894.86395.14
6324466-32446687.82288.07
20min1361594-36159497.87292.684.3998.2993.084.39
2341940-34194092.55292.97
3322997-32299787.42587.81
4335666-33566690.85491.25
5358574-35857497.05497.49
6333615-33361590.29990.69
30min1371578-371578100.57495.353.90101.1595.913.90
2348166-34816694.23794.81
3337411-33741191.32691.86
4346300-34630093.73294.28
5366895-36689599.30699.90
6343303-34330392.92193.47
45min1377261-377261102.11297.313.10102.8698.033.10
2352316-35231695.36096.09
3349796-34979694.67895.36
4354336-35433695.90796.61
5369497-369497100.011100.77
6353858-35385895.77896.48
60min1385883-385883104.44698.373.53105.3699.253.52
2354325-35432595.90496.79
3356045-35604596.37097.21
4358276-35827696.97497.84
5371698-371698100.607101.53
6354350-35435095.91196.77
极限1379350-379350102.678100.122.52103.77101.172.51
2356448-35644896.47997.53
3360387-36038797.54598.55
4376014-376014101.775102.80
5371604-371604100.581101.68
6375581-375581101.658102.68
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