磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.683396023393563393643396283394733394850.04
212.723389543389063389300.02
单位质量响应值RSD%判断
26773.2626645.440.34数据可信
供试品溶液-2025060411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%
5min1377295-37729598.69197.523.6498.6997.523.64
2387658-387658101.402101.40
3380485-38048599.52699.53
4376498-37649898.48398.48
5365655-36565595.64695.65
6349313-34931391.37291.37
10min1380276-38027699.471101.040.9199.64101.200.91
2390517-390517102.150102.32
3387212-387212101.285101.45
4388243-388243101.555101.72
5386597-386597101.124101.28
6384843-384843100.665100.82
15min1380228-38022899.458101.080.9299.79101.420.92
2390364-390364102.110102.45
3387190-387190101.279101.61
4389041-389041101.764102.10
5386535-386535101.108101.44
6385270-385270100.777101.10
20min1379410-37941099.244100.911.0099.74101.411.00
2390114-390114102.044102.55
3386493-386493101.097101.60
4388971-388971101.745102.25
5385831-385831100.924101.42
6383808-383808100.395100.88
30min1378344-37834498.965100.761.0899.63101.431.08
2389171-389171101.798102.48
3385762-385762100.906101.58
4389487-389487101.880102.55
5385200-385200100.759101.42
6383232-383232100.244100.90
45min1377600-37760098.771100.591.1299.60101.431.12
2388286-388286101.566102.42
3384276-384276100.517101.36
4389826-389826101.969102.81
5384261-384261100.513101.35
6383076-383076100.203101.03
极限1377182-37718298.662100.521.1999.65101.531.18
2387753-387753101.427102.45
3384100-384100100.471101.48
4390413-390413102.122103.13
5383628-383628100.348101.35
6382710-382710100.108101.10
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.683396223394253395243393793388853393670.09
212.723398203393893396040.09
单位质量响应值RSD%判断
26763.9626698.430.18数据可信
供试品溶液-2025060412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%
5min1384563-384563100.51097.963.70100.5197.963.70
2353062-35306292.27692.28
3386248-386248100.950100.95
4363138-36313894.91094.91
5375896-37589698.24498.24
6385996-385996100.884100.88
10min1388534-388534101.547100.601.50101.71100.761.50
2376581-37658198.42398.58
3390134-390134101.966102.13
4380627-38062799.48199.64
5382761-382761100.039100.20
6390704-390704102.115102.28
15min1388169-388169101.452100.561.43101.79100.891.43
2376708-37670898.45798.77
3389797-389797101.878102.22
4380724-38072499.50699.83
5382979-382979100.096100.43
6390115-390115101.961102.30
20min1387555-387555101.292100.481.42101.80100.981.42
2376160-37616098.31398.80
3389313-389313101.751102.26
4380836-38083699.536100.03
5382827-382827100.056100.55
6389983-389983101.926102.43
30min1386575-386575101.035100.371.42101.71101.041.42
2375528-37552898.14898.79
3389031-389031101.677102.35
4381156-38115699.619100.27
5382223-38222399.898100.56
6389704-389704101.853102.53
45min1387179-387179101.193100.211.34102.04101.041.35
2374955-37495597.99898.81
3387827-387827101.363102.21
4381691-38169199.759100.58
5381155-38115599.619100.45
6387684-387684101.325102.17
极限1384794-384794100.57099.931.39101.58100.931.39
2373589-37358997.64198.61
3386835-386835101.103102.12
4381262-38126299.647100.63
5379864-37986499.281100.28
6387842-387842101.367102.38
磷酸西格列汀片项目信息
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101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.683391313394103392723388663390193391400.07
212.723385133385603385360.01
单位质量响应值RSD%判断
26746.0626614.470.35数据可信
供试品溶液-2025060511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%
5min1371724-37172497.34096.642.0997.3496.642.09
2377747-37774798.91798.92
3374483-37448398.06298.06
4356368-35636893.31993.32
5369587-36958796.78096.78
6364411-36441195.42595.42
10min1382717-382717100.21999.040.81100.3899.200.81
2380142-38014299.54499.71
3377859-37785998.94699.11
4378491-37849199.11299.27
5375832-37583298.41698.58
6374207-37420797.99098.15
15min1383001-383001100.29399.080.86100.6299.410.86
2380070-38007099.52599.86
3377784-37778498.92799.26
4379469-37946999.36899.69
5376376-37637698.55898.88
6373583-37358397.82798.15
20min1382368-382368100.12799.030.79100.6299.520.79
2379415-37941599.35499.85
3377986-37798698.98099.47
4379517-37951799.38199.87
5375833-37583398.41698.91
6373945-37394597.92198.41
30min1381346-38134699.86098.890.75100.5299.540.75
2378739-37873999.17799.84
3377356-37735698.81599.47
4379394-37939499.348100.00
5375436-37543698.31298.97
6373576-37357697.82598.47
45min1381262-38126299.83898.830.87100.6799.650.87
2378400-37840099.08899.92
3376798-37679898.66999.49
4380314-38031499.589100.41
5375099-37509998.22499.04
6372568-37256897.56198.37
极限1380954-38095499.75798.690.87100.7599.680.87
2378016-37801698.98899.98
3376166-37616698.50399.49
4379545-37954599.388100.37
5374304-37430498.01599.00
6372267-37226797.48298.46
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