二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
110.172365172362402363892365742364472364330.06
210.212376572380902378740.13
单位质量响应值RSD%判断
23248.0823298.140.16数据可信
供试品溶液-301166A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%
5min129285-2928511.2118.9423.7911.218.9423.81
218272-182726.9956.99
322512-225128.6188.62
10min127269-2726910.43910.9023.1710.4610.9123.10
235587-3558713.62313.63
322563-225638.6378.65
15min159123-5912322.63317.4127.9522.6717.4527.90
233973-3397313.00513.04
343362-4336216.59916.63
20min155343-5534321.18621.3824.9821.2621.4424.90
270046-7004626.81426.87
342162-4216216.14016.20
30min189014-8901434.07526.1428.7034.1826.2328.61
250086-5008619.17319.27
365724-6572425.16025.24
45min183252-8325231.86931.8425.2132.0431.9825.11
2104081-10408139.84339.98
362155-6215523.79323.92
60min1116188-11618844.47834.3529.4644.7034.5429.33
263328-6332824.24224.44
389679-8967934.33034.49
极限1110093-11009342.14441.6925.2542.4441.9425.13
2135778-13577851.97752.22
380829-8082930.94231.16
二甲双胍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DA-11412209074对照品来源工作对照品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20
标示量(mg)500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%
19.851072949107182210727531072288107339210726410.06
29.941077107107770010774040.04
单位质量响应值RSD%判断
108897.56108390.740.33数据可信
供试品溶液-301166A批-二甲双胍-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%
5min1275500-27550022.80019.9113.8022.8019.9113.81
2209461-20946117.33417.33
3236821-23682119.59919.60
10min1264941-26494121.92622.4412.8621.9622.4712.82
2308634-30863425.54225.57
3239779-23977919.84319.88
15min1443502-44350236.70331.6415.3236.7831.7115.30
2326868-32686827.05127.12
3376471-37647131.15631.22
20min1426343-42634335.28335.6614.3435.4235.7814.29
2494775-49477540.94641.06
3371467-37146730.74130.86
30min1585484-58548448.45341.3416.4748.6541.5216.41
2421641-42164134.89435.08
3491298-49129840.65840.83
45min1559813-55981346.32846.5214.9946.6046.7714.91
2647461-64746153.58253.82
3479051-47905139.64539.88
60min1702944-70294458.17349.5417.4158.5349.8717.32
2494506-49450640.92441.26
3598454-59845449.52649.83
极限1677565-67756556.07355.9415.6256.5256.3615.52
2780794-78079464.61665.02
3569676-56967647.14547.53
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