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%
1 12.441604231604401605871602341604141604200.08
2 12.491627981627621627800.02
单位质量响应值RSD%判断
12895.5013032.830.75数据可信
供试品溶液-24121901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%
5min191565-9156545.43048.4414.5845.4348.4414.58
284945-8494542.14642.15
3109449-10944954.30354.30
4117482-11748258.28958.29
581221-8122140.29840.30
6101168-10116850.19550.19
10min1149200-14920074.02681.818.1974.0981.888.20
2146490-14649072.68172.74
3172067-17206785.37185.45
4175974-17597487.31087.40
5169071-16907183.88583.95
6176496-17649687.56987.64
15min1164861-16486181.79687.125.2081.9887.325.21
2163372-16337281.05781.23
3180879-18087989.74389.95
4183044-18304490.81791.04
5177897-17789788.26488.45
6183494-18349491.04191.25
20min1170731-17073184.70889.313.6685.0189.643.68
2173021-17302185.84586.14
3184157-18415791.37091.71
4185801-18580192.18592.54
5180835-18083589.72190.04
6185546-18554692.05992.40
30min1176726-17672687.68390.952.5288.1191.422.54
2178662-17866288.64389.07
3186082-18608292.32592.81
4187741-18774193.14893.64
5183615-18361591.10191.55
6187094-18709492.82793.31
45min1181101-18110189.85391.832.1890.4192.432.21
2179374-17937488.99789.55
3187737-18773793.14693.77
4189142-18914293.84394.48
5185093-18509391.83492.42
6188112-18811293.33293.95
60min1183623-18362391.10592.301.7191.8093.041.74
2181283-18128389.94490.63
3188026-18802693.28994.05
4189640-18964094.09094.86
5185442-18544292.00792.73
6188238-18823893.39494.15
极限1186948-18694892.75493.161.5093.5994.031.52
2184377-18437791.47992.30
3188530-18853093.53994.44
4192533-19253395.52596.44
5185882-18588292.22693.09
6188319-18831993.43594.34
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%
1 12.441606141608261607831607831608211607650.06
2 12.491612301613641612970.06
单位质量响应值RSD%判断
12923.2312914.090.06数据可信
供试品溶液-24121902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%
5min1174296-17429686.77975.6012.6686.7875.6012.66
2135013-13501367.22167.22
3152603-15260375.97975.98
4170302-17030284.79184.79
5125103-12510362.28762.29
6153720-15372076.53576.53
10min1197498-19749898.33192.648.3898.4692.758.38
2176747-17674788.00088.10
3184616-18461691.91792.03
4196729-19672997.94898.08
5160182-16018279.75279.85
6200602-20060299.87799.99
15min1202242-202242100.69396.557.02100.9796.807.02
2188314-18831493.75993.99
3196329-19632997.74998.00
4202200-202200100.672100.95
5169052-16905284.16884.38
6205350-205350102.241102.51
20min1205344-205344102.23898.036.46102.6798.436.47
2193999-19399996.58996.96
3197303-19730398.23498.63
4203434-203434101.287101.71
5173227-17322786.24786.59
6208109-208109103.614104.03
30min1207750-207750103.43599.705.90104.02100.245.92
2199015-19901599.08699.60
3202125-202125100.635101.18
4205240-205240102.186102.76
5177460-17746088.35588.82
6209850-209850104.481105.05
45min1209628-209628104.371101.065.18105.11101.755.19
2203019-203019101.080101.75
3205248-205248102.190102.89
4206600-206600102.863103.59
5182365-18236590.79791.40
6210951-210951105.029105.76
60min1210303-210303104.707101.374.70105.60102.224.72
2204584-204584101.859102.68
3203376-203376101.258102.11
4207298-207298103.210104.10
5185069-18506992.14392.88
6210957-210957105.032105.92
极限1210785-210785104.947102.654.00106.00103.654.02
2208630-208630103.874104.85
3208635-208635103.876104.88
4207767-207767103.444104.48
5189637-18963794.41795.29
6211564-211564105.334106.38
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