达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
112.331587111586051582081587961588471586330.17
212.361599421592371595900.32
单位质量响应值RSD%判断
12865.6112911.810.26数据可信
供试品溶液-24120502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%
5min166067-6606732.97033.489.1432.9733.489.15
268350-6835034.11034.11
358595-5859529.24129.24
473777-7377736.81836.82
562047-6204730.96430.96
673641-7364136.75036.75
10min1173841-17384186.75487.172.1886.8087.222.18
2176204-17620487.93387.98
3172283-17228385.97786.02
4179181-17918189.41989.47
5168868-16886884.27284.32
6177695-17769588.67788.73
15min1195702-19570297.66497.661.3197.8497.841.31
2197983-19798398.80298.99
3197500-19750098.56198.73
4195732-19573297.67997.87
5190836-19083695.23595.41
6196407-19640798.01698.20
20min1199427-19942799.52399.521.1899.8599.841.18
2201216-201216100.415100.75
3201699-201699100.656100.98
4198499-19849999.06099.40
5195252-19525297.43997.75
6200393-200393100.005100.34
30min1202167-202167100.890100.931.04101.37101.411.04
2204055-204055101.832102.31
3204743-204743102.176102.65
4201412-201412100.513101.00
5198816-19881699.21899.68
6202324-202324100.968101.45
45min1203269-203269101.440101.701.13102.07102.331.13
2204023-204023101.816102.45
3205876-205876102.741103.37
4202795-202795101.203101.84
5200216-20021699.916100.53
6206568-206568103.086103.72
60min1203813-203813101.711101.841.04102.49102.621.04
2205358-205358102.482103.27
3206725-206725103.165103.94
4203053-203053101.332102.12
5200594-200594100.105100.87
6204841-204841102.224103.02
极限1204687-204687102.148102.031.17103.08102.961.17
2205474-205474102.540103.48
3207584-207584103.593104.53
4203520-203520101.565102.50
5200407-200407100.012100.92
6205060-205060102.334103.28
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
112.331589471588721594241590891593701591400.16
212.361586821584871585840.09
单位质量响应值RSD%判断
12906.7312830.420.42数据可信
供试品溶液-24120503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%
5min16630-66303.3143.6967.553.313.6867.58
25168-51682.5832.58
317448-174488.7218.72
45364-53642.6812.68
54590-45902.2942.29
65054-50542.5262.53
10min162630-6263031.30429.967.6031.3129.977.61
259536-5953629.75829.76
367264-6726433.62033.63
455810-5581027.89527.90
554887-5488727.43427.44
659546-5954629.76329.77
15min1122401-12240161.17958.257.3361.2358.307.34
2112645-11264556.30356.35
3129549-12954964.75264.82
4109883-10988354.92254.97
5106612-10661253.28853.33
6118211-11821159.08559.13
20min1174531-17453187.23583.506.3287.3883.646.32
2157251-15725178.59878.73
3181082-18108290.51090.67
4160644-16064480.29480.42
5155719-15571977.83277.96
6173169-17316986.55486.69
30min1189676-18967694.80595.221.8595.0895.481.86
2188537-18853794.23694.49
3197430-19743098.68198.98
4187908-18790893.92194.17
5190438-19043895.18695.43
6188990-18899094.46294.73
45min1192839-19283996.38697.421.7996.8097.821.79
2194140-19414097.03697.43
3201271-201271100.601101.05
4193151-19315196.54296.93
5196262-19626298.09798.48
6191742-19174295.83896.25
60min1193588-19358896.76098.271.5497.3298.821.54
2195864-19586497.89898.44
3201867-201867100.898101.49
4195178-19517897.55598.09
5198332-19833299.13299.66
6194826-19482697.37997.93
极限1194362-19436297.14798.701.3697.8599.391.37
2197024-19702498.47899.16
3202324-202324101.127101.87
4197855-19785598.89399.57
5197242-19724298.58799.27
6195950-19595097.94198.64
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