达格列净片项目信息
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%
112.692072072069182069262071802070342070530.07
212.852081702082972082340.05
单位质量响应值RSD%判断
16316.2316204.980.49数据可信
供试品溶液-2025080421批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179979-17997988.99188.391.1688.9988.391.15
2177172-17717287.60387.60
3181618-18161889.80189.80
4176165-17616587.10587.11
5177749-17774987.88887.89
6179858-17985888.93188.93
10min1191998-19199894.93494.171.4495.0794.301.44
2188291-18829193.10193.23
3194349-19434996.09696.23
4186784-18678492.35692.49
5189789-18978993.84293.97
6191474-19147494.67594.81
15min1196511-19651197.16596.461.4797.4496.731.46
2192667-19266795.26595.54
3199317-19931798.55398.83
4191274-19127494.57694.85
5195016-19501696.42696.70
6195700-19570096.76497.04
20min1199399-19939998.59397.741.6699.0198.161.66
2194790-19479096.31496.73
3202392-202392100.073100.50
4193244-19324495.55095.96
5198078-19807897.94098.36
6198188-19818897.99598.42
30min1201429-20142999.59798.981.75100.1799.541.75
2196995-19699597.40597.96
3205803-205803101.760102.34
4196017-19601796.92197.48
5200927-20092799.34999.91
6199876-19987698.82999.40
45min1202328-202328100.04299.471.92100.76100.181.91
2197504-19750497.65698.36
3207387-207387102.543103.27
4196749-19674997.28397.98
5202157-20215799.957100.67
6200871-20087199.321100.04
极限1202459-202459100.10699.601.94100.98100.461.94
2197770-19777097.78898.64
3207917-207917102.805103.69
4197324-19732497.56798.41
5202667-202667100.209101.07
6200464-20046499.12099.98
达格列净片项目信息
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%
112.692067182068912069732070132067242068640.07
212.852082592080352081470.08
单位质量响应值RSD%判断
16301.3416198.210.45数据可信
供试品溶液-2025080421批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179102-17910288.61688.210.9388.6288.210.94
2180100-18010089.11089.11
3177777-17777787.96187.96
4177343-17734387.74687.75
5175681-17568186.92486.92
6179639-17963988.88288.88
10min1190998-19099894.50293.870.8894.6494.000.88
2191220-19122094.61294.75
3188960-18896093.49493.63
4188893-18889393.46193.59
5187112-18711292.57992.71
6191081-19108194.54394.68
15min1195779-19577996.86896.150.9497.1496.420.94
2195771-19577196.86497.14
3193977-19397795.97696.25
4194136-19413696.05596.33
5190969-19096994.48894.76
6195347-19534796.65496.93
20min1198050-19805097.99197.431.0698.4197.851.06
2198927-19892798.42598.85
3196313-19631397.13297.55
4197518-19751897.72898.14
5193051-19305195.51895.93
6197644-19764497.79198.21
30min1199939-19993998.92698.511.0599.4999.081.04
2201102-20110299.501100.07
3199291-19929198.60599.17
4199919-19991998.91699.48
5195099-19509996.53197.09
6199286-19928698.60399.17
45min1200810-20081099.35798.971.14100.0799.681.14
2202721-202721100.303101.02
3199685-19968598.80099.51
4200852-20085299.378100.09
5195872-19587296.91497.61
6200244-20024499.07799.79
极限1200841-20084199.37298.961.13100.2499.821.13
2202897-202897100.390101.26
3199426-19942698.67299.53
4200153-20015399.03299.89
5196054-19605497.00497.85
6200702-20070299.304100.17
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