非奈利酮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1000
标示量(mg)10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%
111.163093323092253093113095133091523093070.05
211.143081473085823083640.10
单位质量响应值RSD%判断
27715.6827680.790.09数据可信
供试品溶液-6022601批-恩格列净-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%
5min1185309-18530960.21362.3718.3560.2162.3718.35
2152550-15255049.56849.57
3229271-22927174.49774.50
4231066-23106675.08075.08
5201498-20149865.47365.47
6152067-15206749.41149.41
10min1286520-28652093.09994.211.6893.2094.321.70
2282187-28218791.69191.77
3295965-29596596.16896.29
4290739-29073994.47094.60
5291860-29186094.83494.94
6292429-29242995.01995.10
15min1295885-29588596.14296.831.0696.4097.091.08
2293583-29358395.39495.63
3302624-30262498.33298.62
4298144-29814496.87697.16
5300009-30000997.48297.75
6297678-29767896.72596.97
20min1298258-29825896.91397.581.0997.3398.011.10
2296983-29698396.49996.89
3305996-30599699.42799.88
4299562-29956297.33797.78
5302093-30209398.15998.59
6299036-29903697.16697.57
30min1301344-30134497.91698.260.7798.4998.840.78
2300014-30001497.48498.04
3305500-30550099.26699.88
4301511-30151197.97098.58
5305098-30509899.13699.73
6300939-30093997.78498.35
45min1302521-30252198.29898.690.8999.0499.440.90
2300750-30075097.72398.44
3306931-30693199.731100.51
4303140-30314098.49999.27
5307175-30717599.811100.57
6301888-30188898.09398.82
60min1303480-30348098.61098.950.8299.5199.860.83
2301818-30181898.07098.95
3306848-30684899.704100.65
4303747-30374798.69799.63
5308310-308310100.179101.10
6303007-30300798.45699.35
极限1304019-30401998.78598.980.9399.85100.060.94
2301588-30158897.99599.04
3306735-30673599.668100.78
4304120-30412098.81899.92
5309056-309056100.422101.51
6302218-30221898.20099.25
非奈利酮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D250501对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.153977943978353977253979853977753978230.03
211.223963693967563965620.07
单位质量响应值RSD%判断
35679.1935344.210.67数据可信
供试品溶液-6022601批-非奈利酮-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%
5min130493-304937.72111.5550.317.7211.5550.31
225680-256806.5026.50
374102-7410218.76218.76
473210-7321018.53618.54
545401-4540111.49511.50
624797-247976.2786.28
10min1181122-18112245.85847.986.0145.8748.006.02
2170758-17075843.23443.25
3192883-19288348.83648.87
4198643-19864350.29450.33
5193378-19337848.96148.98
6200293-20029350.71250.72
15min1247885-24788562.76264.082.3862.8564.182.39
2243357-24335761.61661.70
3256680-25668064.98965.10
4255462-25546264.68064.80
5256930-25693065.05265.15
6258162-25816265.36465.46
20min1284696-28469672.08273.291.8372.2873.501.84
2281523-28152371.27971.46
3294966-29496674.68274.90
4289855-28985573.38873.61
5293356-29335674.27574.48
6292428-29242874.04074.24
30min1327569-32756982.93783.701.2183.2584.031.22
2324565-32456582.17782.48
3334083-33408384.58684.93
4329807-32980783.50483.85
5334508-33450884.69485.03
6332927-33292784.29484.62
45min1356913-35691390.36791.171.1190.8291.641.12
2354472-35447289.74990.19
3364851-36485192.37792.86
4358885-35888590.86691.35
5363173-36317391.95292.43
6362192-36219291.70392.17
60min1371611-37161194.08894.801.0494.6995.421.05
2368835-36883593.38593.98
3378553-37855395.84696.49
4373009-37300994.44295.08
5377776-37777695.64996.28
6376764-37676495.39396.01
极限1377138-37713895.48796.091.0596.2596.871.06
2373360-37336094.53195.28
3383803-38380397.17597.98
4378294-37829495.78096.57
5382871-38287196.93997.73
6381671-38167196.63597.41
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