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(%)96.5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%
112.813342633350833346383345843363743349880.25
212.853352073346103349080.13
单位质量响应值RSD%判断
26150.5126062.880.24数据可信
供试品溶液-2025030122批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1370090-37009099.24798.520.8999.2598.520.89
2362824-36282497.29897.30
3370618-37061899.38899.39
4369855-36985599.18499.18
5365900-36590098.12398.12
6364930-36493097.86397.86
10min1372663-37266399.93799.440.85100.1099.610.85
2366861-36686198.38198.54
3375284-375284100.639100.81
4372387-37238799.863100.03
5369344-36934499.04799.21
6368404-36840498.79498.96
15min1373734-373734100.22499.290.81100.5699.620.82
2366651-36665198.32498.65
3372767-37276799.964100.30
4372113-37211399.789100.12
5368993-36899398.95299.28
6367343-36734398.51098.84
20min1371366-37136699.58998.990.78100.0999.490.78
2366545-36654598.29698.79
3372620-37262099.925100.43
4370892-37089299.46299.96
5367806-36780698.63499.13
6365649-36564998.05698.55
30min1371118-37111899.52298.890.79100.1999.550.79
2365080-36508097.90398.56
3371953-37195399.746100.41
4370823-37082399.443100.11
5367094-36709498.44399.10
6366478-36647898.27898.93
45min1370243-37024399.28898.650.72100.1299.470.72
2364470-36447097.73998.56
3370797-37079799.436100.27
4369373-36937399.05499.88
5366699-36669998.33799.16
6365534-36553498.02598.84
极限1370078-37007899.24398.560.89100.2499.550.88
2362965-36296597.33698.32
3371150-37115099.531100.53
4369673-36967399.135100.13
5366095-36609598.17599.16
6365203-36520397.93698.92
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(%)96.5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%
112.813347843348543340953340383336063342750.16
212.853333763333143333450.02
单位质量响应值RSD%判断
26094.8525941.250.42数据可信
供试品溶液-2025030222批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1368446-36844699.14397.911.9399.1497.901.93
2367634-36763498.92498.92
3354205-35420595.31195.31
4359979-35997996.86596.86
5373045-373045100.380100.38
6359827-35982796.82496.82
10min1369336-36933699.38298.751.3699.5598.921.36
2369881-36988199.52999.69
3364101-36410197.97498.13
4361989-36198997.40597.57
5374375-374375100.738100.91
6362330-36233097.49797.66
15min1368985-36898599.28898.581.4199.6298.911.41
2368851-36885199.25299.58
3363994-36399497.94598.27
4361449-36144997.26097.58
5374070-374070100.656100.99
6360855-36085597.10097.42
20min1368062-36806299.04098.331.3099.5498.831.30
2367741-36774198.95399.45
3362651-36265197.58498.07
4360677-36067797.05297.54
5372492-372492100.232100.73
6361027-36102797.14797.63
30min1367250-36725098.82197.951.3599.4898.601.35
2367298-36729898.83499.50
3361422-36142297.25397.90
4359428-35942896.71697.36
5370249-37024999.628100.30
6358353-35835396.42797.07
45min1365790-36579098.42897.761.4899.2598.581.48
2367552-36755298.90299.73
3360248-36024896.93797.75
4357720-35772096.25797.07
5370518-37051899.700100.54
6358099-35809996.35997.17
极限1366407-36640798.59497.651.3799.5898.631.37
2366201-36620198.53999.53
3359426-35942696.71697.69
4358153-35815396.37397.34
5369284-36928499.368100.37
6357911-35791196.30897.28
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(%)96.5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%
112.813336803330043333313331273328343331950.10
212.853325753321063323400.10
单位质量响应值RSD%判断
26010.5425863.040.41数据可信
供试品溶液-2025030322批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1366669-36666998.97497.481.1798.9797.481.17
2361900-36190097.68797.69
3358601-35860196.79696.80
4364748-36474898.45598.46
5359774-35977497.11397.11
6355129-35512995.85995.86
10min1370102-37010299.90098.281.12100.0798.451.12
2366008-36600898.79598.96
3361333-36133397.53397.69
4366278-36627898.86899.03
5361901-36190197.68797.85
6359082-35908296.92697.09
15min1370124-37012499.90698.231.15100.2498.561.15
2364920-36492098.50298.83
3360658-36065897.35197.68
4366828-36682899.01799.35
5361894-36189497.68598.01
6359048-35904896.91797.24
20min1368955-36895599.59198.041.18100.0998.531.18
2364784-36478498.46598.96
3361377-36137797.54598.03
4366130-36613098.82899.32
5360946-36094697.42997.92
6357006-35700696.36696.85
30min1369674-36967499.78597.901.29100.4598.551.29
2364079-36407998.27598.93
3359419-35941997.01797.67
4365406-36540698.63399.29
5360964-36096497.43498.08
6356592-35659296.25496.90
45min1369485-36948599.73497.801.28100.5698.621.28
2364225-36422598.31499.13
3359364-35936497.00297.81
4364136-36413698.29099.11
5360541-36054197.32098.13
6356206-35620696.15096.95
极限1369635-36963599.77497.661.35100.7798.641.35
2363136-36313698.02099.00
3357686-35768696.54997.52
4363751-36375198.18699.17
5360489-36048997.30698.28
6356070-35607096.11397.08
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