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%
110.295772565770975776785774975770855773230.05
210.355785465786235785840.01
单位质量响应值RSD%判断
56105.2555901.840.26数据可信
供试品溶液-2024052811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%
5min159079-590799.39810.8713.159.4010.8713.13
277008-7700812.25112.25
368932-6893210.96610.97
10min153188-531888.46111.9238.118.4811.9438.05
264300-6430010.22910.25
3107233-10723317.05917.08
15min1100782-10078216.03316.355.1516.0616.395.13
2108769-10876917.30317.34
398776-9877615.71315.76
20min162344-623449.91816.5341.519.9716.6041.41
2100959-10095916.06116.13
3148467-14846723.61823.69
30min1133261-13326121.19920.713.8621.2720.803.75
2132847-13284721.13421.23
3124370-12437019.78519.90
45min184115-8411513.38120.1336.1513.4920.2636.00
2120486-12048619.16719.30
3174984-17498427.83727.98
60min1164531-16453126.17424.715.8726.3024.875.69
2155176-15517624.68624.85
3146329-14632923.27823.47
极限1104498-10449816.62423.2531.2816.8023.4631.12
2138965-13896522.10722.31
3195066-19506631.03131.26
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%
110.295783045793665785275783615782865785690.08
210.355788095792645790360.06
单位质量响应值RSD%判断
56226.3455945.510.36数据可信
供试品溶液-2024052811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%
5min1441770-44177070.17468.592.2570.1768.592.25
2431138-43113868.48668.49
3422391-42239167.09667.10
10min1382694-38269460.79059.774.0160.9159.894.01
2387123-38712361.49461.61
3359076-35907657.03957.15
15min1488974-48897477.67377.600.7777.8977.810.77
2492017-49201778.15678.37
3484590-48459076.97677.18
20min1493863-49386378.44977.501.3478.8077.851.34
2488901-48890177.66178.01
3480975-48097576.40276.74
30min1500934-50093479.57379.660.9280.0580.140.92
2506357-50635780.43480.91
3497228-49722878.98479.45
45min1514312-51431281.69881.300.4382.3181.910.43
2510727-51072781.12881.74
3510440-51044081.08381.68
60min1507283-50728380.58180.611.3081.3381.351.30
2514121-51412181.66782.41
3501001-50100179.58380.31
极限1522392-52239282.98182.650.3583.8683.520.36
2519418-51941882.50983.39
3519098-51909882.45883.32
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