恩格列净片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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400
标示量(mg)25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%
110.291419050141964614200481418968142011614195660.04
210.351419249142000014196240.04
单位质量响应值RSD%判断
137955.88137161.740.41数据可信
供试品溶液-2024052411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%
5min1138106-1381068.9455.4056.958.945.4056.92
253905-539053.4913.49
358058-580583.7603.76
10min1144153-1441539.3368.8045.059.348.8045.06
2192362-19236212.45912.46
370891-708914.5914.59
15min1183482-18348211.8837.9642.8111.887.9642.81
288921-889215.7595.76
396248-962486.2346.23
20min1204205-20420513.22612.2033.9413.2312.2033.93
2242730-24273015.72115.72
3117932-1179327.6387.64
30min1213808-21380813.84810.0632.6713.8510.0632.68
2123287-1232877.9857.98
3128866-1288668.3468.35
45min1253110-25311016.39314.6228.3416.3914.6128.35
2271332-27133217.57317.57
3152573-1525739.8829.88
60min1238676-23867615.45812.2323.0915.4612.2323.08
2169676-16967610.98910.99
3158064-15806410.23710.24
极限1288169-28816918.66416.5824.2818.6616.5824.28
2295577-29557719.14319.14
3184423-18442311.94411.94
恩格列净片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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400
标示量(mg)25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%
110.291426144142574814244681424715142518814252530.05
210.351437838143813414379860.02
单位质量响应值RSD%判断
138508.55138935.850.22数据可信
供试品溶液-2024052411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%
5min1836038-83603853.69351.4419.6553.6951.4419.65
2937785-93778560.22760.23
3628993-62899340.39640.40
10min1784717-78471750.39749.342.6950.4049.342.68
2774855-77485549.76349.76
3745156-74515647.85647.86
15min11066723-106672368.50867.277.9868.5167.277.99
21119682-111968271.90971.91
3955965-95596561.39561.39
20min11027934-102793466.01766.911.6066.0266.911.60
21060252-106025268.09268.09
31037326-103732666.62066.62
30min11126174-112617472.32670.577.7472.3370.577.74
21166724-116672474.93074.93
31003569-100356964.45264.45
45min11113568-111356871.51672.501.7871.5272.501.78
21151645-115164573.96273.96
31121509-112150972.02672.03
60min11163423-116342374.71872.488.0574.7272.488.05
21196582-119658276.84876.85
31025500-102550065.86065.86
极限11151874-115187473.97774.691.0473.9874.691.04
21175862-117586275.51775.52
31161334-116133474.58474.58
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