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101546-202302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%
1 12.683398423399213400043398743398983399080.02
2 12.723394493392593393540.04
单位质量响应值RSD%判断
26806.6226678.770.34数据可信
供试品溶液-2025060411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%
5min1350440-35044091.55294.722.7491.5594.722.75
2368806-36880696.35096.35
3362582-36258294.72494.72
4372302-37230297.26497.26
5370794-37079496.87096.87
6350526-35052691.57591.57
10min1375684-37568498.14798.670.5998.3098.830.59
2376168-37616898.27498.43
3378993-37899399.01299.17
4381220-38122099.59399.76
5378246-37824698.81698.98
6375866-37586698.19598.35
15min1377998-37799898.75299.170.6399.0799.490.63
2377133-37713398.52698.85
3381215-38121599.59299.92
4383467-383467100.180100.51
5379529-37952999.15299.48
6378220-37822098.81099.13
20min1379479-37947999.13999.290.7399.6299.780.73
2377044-37704498.50298.99
3381217-38121799.593100.08
4384807-384807100.531101.03
5379696-37969699.19599.69
6378032-37803298.76199.24
30min1379686-37968699.19399.510.7699.84100.170.76
2378477-37847798.87799.53
3382784-382784100.002100.66
4385822-385822100.796101.46
5380166-38016699.31899.97
6378579-37857998.90399.55
45min1380303-38030399.35499.700.75100.17100.520.74
2379034-37903499.02299.84
3384108-384108100.348101.17
4386120-386120100.874101.70
5380456-38045699.394100.22
6379668-37966899.188100.00
极限1381082-38108299.557100.380.95100.53101.360.95
2381599-38159999.692100.68
3385895-385895100.815101.80
4390767-390767102.088103.09
5383224-383224100.117101.10
6382710-38271099.983100.96
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101546-202302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%
1 12.683399863398783401943399683397523399560.05
2 12.723390243387293388760.07
单位质量响应值RSD%判断
26810.4126641.190.45数据可信
供试品溶液-2025060412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%
5min1371614-37161497.14692.953.4497.1592.953.44
2353954-35395492.52992.53
3352396-35239692.12292.12
4367267-36726796.00996.01
5350179-35017991.54291.54
6337954-33795488.34688.35
10min1380473-38047399.46297.801.6599.6297.961.65
2365979-36597995.67395.83
3375369-37536998.12798.28
4381622-38162299.76299.92
5371473-37147397.10997.26
6369789-36978996.66996.82
15min1381635-38163599.76598.191.72100.0998.501.72
2367319-36731996.02396.34
3376098-37609898.31898.63
4384149-384149100.422100.75
5373841-37384197.72898.04
6370567-37056796.87297.18
20min1381585-38158599.75298.331.66100.2598.811.66
2368227-36822796.26096.73
3376311-37631198.37498.85
4384891-384891100.616101.11
5374226-37422697.82898.31
6371550-37155097.12997.60
30min1381688-38168899.77998.551.68100.4499.201.68
2368846-36884696.42297.06
3377059-37705998.56999.21
4386395-386395101.010101.67
5375610-37561098.19098.83
6372425-37242597.35897.99
45min1383526-383526100.26099.051.78101.0999.861.78
2371149-37114997.02497.82
3379146-37914699.11599.92
4389243-389243101.754102.58
5377450-37745098.67199.48
6372858-37285897.47198.26
极限1386658-386658101.07899.921.72102.07100.901.72
2375176-37517698.07799.03
3383081-383081100.143101.12
4392333-392333102.562103.56
5380166-38016699.381100.35
6376045-37604598.30499.26
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101546-202302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%
1 12.683396963398893401163400303400383399540.05
2 12.723393933388143391040.13
单位质量响应值RSD%判断
26810.2526659.120.40数据可信
供试品溶液-2025060511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%
5min1366909-36690995.88490.814.8595.8890.814.85
2342646-34264689.54389.54
3326833-32683385.41185.41
4330416-33041686.34786.35
5355460-35546092.89292.89
6362810-36281094.81294.81
10min1377091-37709198.54496.921.0498.7097.071.04
2366944-36694495.89396.04
3369867-36986796.65796.80
4369590-36959096.58496.73
5373696-37369697.65797.81
6367975-36797596.16296.32
15min1376969-37696998.51397.570.9198.8497.880.91
2368869-36886996.39696.70
3375634-37563498.16498.47
4373442-37344297.59197.90
5375599-37559998.15598.47
6369606-36960696.58896.91
20min1377688-37768898.70097.670.9899.1998.150.98
2368498-36849896.29996.77
3375645-37564598.16798.63
4374685-37468597.91698.38
5375991-37599198.25798.74
6370072-37007296.71097.19
30min1378263-37826398.85197.860.9599.5098.500.95
2370012-37001296.69597.32
3376054-37605498.27398.90
4376218-37621898.31698.95
5376259-37625998.32798.97
6370021-37002196.69797.34
45min1378377-37837798.88198.090.8699.7098.900.86
2371161-37116196.99597.79
3376451-37645198.37799.17
4377440-37744098.63699.43
5377295-37729598.59899.41
6371441-37144197.06897.87
极限1381554-38155499.71198.820.71100.6999.780.71
2374574-37457497.88798.84
3377606-37760698.67999.64
4379673-37967399.219100.18
5379793-37979399.251100.22
6375676-37567698.17599.14
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