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200
标示量(mg)50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%
110.212830911283193028313692831793282992528311860.03
210.29285082151541427988140.92
单位质量响应值RSD%判断
277295.40138774.3447.09数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024053011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%
5min12218193-2218193106.836104.692.44106.84104.682.44
22195325-2195325105.735105.73
32211015-2211015106.490106.49
42159274-2159274103.998104.00
52183083-2183083105.145105.14
62074478-207447899.91499.91
10min12715877-2715877130.806128.171.41130.98128.351.41
22663464-2663464128.282128.46
32680473-2680473129.101129.28
42649749-2649749127.621127.79
52655556-2655556127.901128.08
62602335-2602335125.338125.50
15min12843460-2843460136.951135.221.20137.35135.611.20
22808975-2808975135.290135.68
32800728-2800728134.893135.29
42844994-2844994137.025137.41
52789961-2789961134.374134.76
62756761-2756761132.775133.15
20min12922654-2922654140.765138.421.43141.39139.031.43
22867189-2867189138.094138.71
32858937-2858937137.696138.31
42924336-2924336140.846141.46
52845662-2845662137.057137.67
62824673-2824673136.046136.64
30min13005593-3005593144.760142.071.48145.62142.921.48
22962868-2962868142.702143.55
32929828-2929828141.111141.96
42988902-2988902143.956144.81
52918949-2918949140.587141.43
62892701-2892701139.323140.15
45min13043631-3043631146.592144.641.26147.69145.711.26
23041713-3041713146.500147.58
32971810-2971810143.133144.21
43025204-3025204145.704146.79
52964877-2964877142.799143.87
62970770-2970770143.083144.14
60min13051874-3051874146.989145.401.10148.33146.721.10
23056366-3056366147.205148.53
32984361-2984361143.737145.06
43035525-3035525146.202147.53
52985884-2985884143.811145.12
62998879-2998879144.437145.73
极限13075143-3075143148.110148.090.83149.70149.660.83
23114390-3114390150.000151.57
33045564-3045564146.685148.25
43092273-3092273148.935150.51
53067293-3067293147.732149.28
63054248-3054248147.103148.64
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200
标示量(mg)50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%
110.2128367649765966066618361371614138202.38
210.292837576284268328401300.13
单位质量响应值RSD%判断
60150.64276008.7590.82数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024053011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%
5min12137780-2137780192.819190.723.17192.82190.723.17
22094946-2094946188.955188.96
32211330-2211330199.453199.45
42011284-2011284181.409181.41
52142594-2142594193.253193.25
62089392-2089392188.454188.45
10min12663727-2663727240.257238.741.31240.58239.061.31
22614413-2614413235.809236.12
32671919-2671919240.996241.33
42607504-2607504235.186235.49
52693681-2693681242.959243.28
62630074-2630074237.221237.54
15min12808156-2808156253.284252.350.96254.01253.060.96
22785414-2785414251.232251.94
32808778-2808778253.340254.07
42779835-2779835250.729251.42
52839839-2839839256.141256.87
62764599-2764599249.355250.06
20min12875910-2875910259.395258.511.09260.54259.651.09
22864385-2864385258.355259.48
32890117-2890117260.676261.83
42838703-2838703256.039257.15
52905036-2905036262.022263.18
62822531-2822531254.580255.71
30min12962908-2962908267.242266.120.97268.82267.690.98
22953865-2953865266.426267.98
32976054-2976054268.427270.02
42914551-2914551262.880264.42
52979145-2979145268.706270.30
62916524-2916524263.058264.61
45min13003771-3003771270.927270.300.57272.95272.310.58
22987383-2987383269.449271.45
33014215-3014215271.869273.91
42968491-2968491267.745269.72
53011049-3011049271.584273.62
62995703-2995703270.200272.19
60min12994054-2994054270.051270.970.42272.52273.430.42
22992302-2992302269.893272.34
33022211-3022211272.591275.08
42994153-2994153270.060272.48
53012795-3012795271.741274.23
63009782-3009782271.470273.91
极限13026758-3026758273.001274.260.61275.92277.170.61
23024899-3024899272.833275.73
33058685-3058685275.880278.83
43036110-3036110273.844276.72
53068317-3068317276.749279.69
63029363-3029363273.236276.13
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