氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373340103339083347013344223344333342950.10
214.323337723338873338300.03
单位质量响应值RSD%判断
23263.4023312.150.15数据可信
供试品溶液-2025011521批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1219111-21911154.59749.0513.9054.6049.0513.90
2206200-20620051.38051.38
3144097-14409735.90635.91
4215915-21591553.80153.80
5195662-19566248.75448.75
6200036-20003649.84449.84
10min1351077-35107787.48085.729.0787.5785.809.07
2367893-36789391.67091.76
3282976-28297670.51170.57
4365976-36597691.19391.28
5347241-34724186.52486.61
6348871-34887186.93087.01
15min1393819-39381998.13098.825.1998.3799.045.20
2390358-39035897.26897.51
3364945-36494590.93691.11
4407197-407197101.464101.71
5427522-427522106.528106.75
6395580-39558098.56998.80
20min1392157-39215797.716100.722.1398.12101.112.11
2416204-416204103.708104.11
3408381-408381101.759102.09
4403865-403865100.634101.04
5407547-407547101.551101.95
6397079-39707998.94399.34
30min1392882-39288297.89799.621.3798.46100.181.35
2395293-39529398.49899.07
3403006-403006100.420100.92
4406025-406025101.172101.75
5404578-404578100.811101.38
6397002-39700298.92499.48
45min1384350-38435095.77199.272.4596.5099.992.42
2393653-39365398.08998.83
3408390-408390101.761102.43
4402296-402296100.243100.99
5408793-408793101.862102.60
6392811-39281197.87998.60
极限1389304-38930497.00599.562.2297.89100.452.20
2393349-39334998.01398.91
3408972-408972101.906102.74
4407447-407447101.526102.44
5406096-406096101.190102.10
6392196-39219697.72698.61
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.373343853343593341343344293341773342970.04
214.323334703336523335610.04
单位质量响应值RSD%判断
23263.5423293.370.10数据可信
供试品溶液-2025011521批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1201150-20115050.14247.5519.1950.1447.5519.19
2190192-19019247.41047.41
3118259-11825929.47929.48
4207835-20783551.80851.81
5215522-21552253.72553.72
6211481-21148152.71752.72
10min1350567-35056787.38885.8910.5387.4785.9710.54
2335637-33563783.66683.75
3276659-27665968.96569.01
4363972-36397290.73090.82
5378925-37892594.45794.55
6361514-36151490.11790.20
15min1388894-38889496.94298.074.3397.1798.304.35
2397664-39766499.12899.35
3362025-36202590.24490.41
4402178-402178100.253100.49
5398352-39835299.30099.55
6411423-411423102.558102.80
20min1392230-39223097.77499.811.3198.16100.191.32
2397240-39724099.02299.41
3401276-401276100.029100.34
4402135-402135100.243100.65
5401548-401548100.096100.51
6407857-407857101.669102.08
30min1388953-38895396.95799.991.9197.51100.541.89
2399357-39935799.550100.10
3407744-407744101.641102.12
4402694-402694100.382100.95
5397779-39777999.15799.74
6410236-410236102.262102.84
45min1392746-39274697.902100.151.8298.62100.871.80
2398778-39877899.406100.12
3408070-408070101.722102.37
4404030-404030100.715101.45
5395599-39559998.61399.36
6411422-411422102.558103.31
极限1390653-39065397.381101.003.0498.26101.883.02
2395723-39572398.64499.52
3408516-408516101.833102.65
4401123-40112399.990100.90
5425452-425452106.055106.96
6409479-409479102.073102.99
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