非奈利酮恩格列净片项目信息
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(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163132623133643129293142273138643135290.17
211.133154283156313155300.05
单位质量响应值RSD%判断
28094.0028349.510.65数据可信
供试品溶液-G79580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%
5min139128-3912862.39169.579.0262.3969.579.02
245379-4537972.35972.36
346387-4638773.96673.97
10min146455-4645574.07584.7911.3174.7785.5611.29
255027-5502787.74388.55
358040-5804092.54893.37
15min146734-4673474.52084.069.8776.0485.779.88
255208-5520888.03289.81
356200-5620089.61491.46
20min147073-4707375.06084.079.4177.4086.729.43
254777-5477787.34590.10
356329-5632989.81992.67
30min145999-4599973.34883.0010.3976.5386.5910.37
253766-5376685.73289.46
356397-5639789.92893.77
45min146365-4636573.93183.279.9877.9287.779.98
253952-5395286.02990.71
356340-5634089.83794.68
60min145983-4598373.32282.419.8578.1487.849.85
253296-5329684.98390.62
355764-5576488.91894.76
90min147512-4751275.76083.738.4381.3990.078.54
254080-5408086.23392.81
355936-5593689.19396.02
120min146653-4665374.39081.728.1280.8689.008.25
252352-5235283.47891.02
354746-5474687.29595.12
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限155572-5557288.61288.521.1795.9196.701.43
254842-5484287.44895.91
356130-5613089.50298.29
非奈利酮恩格列净片项目信息
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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003935243944873941913960083953543947130.25
211.023975513979363977440.07
单位质量响应值RSD%判断
35883.0036092.920.42数据可信
供试品溶液-G79580批-非奈利酮-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%
5min18831-883111.03110.7611.3311.0310.7611.36
29468-946811.82711.83
37551-75519.4339.43
10min121953-2195327.42330.6519.3727.5530.7719.32
230019-3001937.49937.63
321634-2163427.02527.13
15min128671-2867135.81539.8718.8436.2440.3318.82
238852-3885248.53349.08
328223-2822335.25635.66
20min134186-3418642.70447.0615.7543.5347.9715.77
244523-4452355.61756.70
334318-3431842.86943.67
30min141967-4196752.42457.6213.3953.7259.0513.48
253219-5321966.48068.19
343197-4319753.96155.23
45min151200-5120063.95869.2510.4465.8471.3210.59
262027-6202777.48379.93
353092-5309266.32168.19
60min157186-5718671.43676.127.7774.0378.958.00
266253-6625382.76286.07
359357-5935774.14776.76
90min166579-6657983.16985.903.4186.5689.593.77
271240-7124088.99193.22
368482-6848285.54688.98
120min168559-6855985.64287.712.0589.9592.352.27
270938-7093888.61493.83
371151-7115188.88093.26
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限168905-6890586.07588.492.4591.3494.102.55
271369-7136989.15395.35
372249-7224990.25295.62
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