艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493815793801303809923814853815253811420.17
214.403806983798153802560.17
单位质量响应值RSD%判断
26303.8026406.670.28数据可信
供试品溶液-2026032521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%
5min1227912-22791259.71658.904.7459.7258.904.74
2220354-22035457.73657.74
3224933-22493358.93658.94
4244105-24410563.95963.96
5215217-21521756.39056.39
6216343-21634356.68556.68
10min1276299-27629972.39473.304.7872.4973.404.78
2272047-27204771.28071.38
3271467-27146771.12871.23
4306659-30665980.34980.46
5275987-27598772.31372.41
6276175-27617572.36272.46
15min1292730-29273076.69978.793.8676.9279.003.86
2297213-29721377.87478.09
3293373-29337376.86877.08
4323768-32376884.83285.07
5297988-29798878.07778.29
6299100-29910078.36878.58
20min1302004-30200479.12982.644.2079.4883.004.19
2316639-31663982.96483.31
3307773-30777380.64180.99
4340302-34030289.16489.55
5312048-31204881.76182.11
6313721-31372182.19982.55
30min1312615-31261581.91087.424.3882.3987.914.38
2335435-33543587.88988.37
3341778-34177889.55190.03
4355848-35584893.23793.77
5328655-32865586.11286.59
6327498-32749885.80986.29
45min1323785-32378584.83690.704.2085.4591.334.20
2349018-34901891.44892.08
3349527-34952791.58192.21
4368482-36848296.54897.23
5340070-34007089.10389.73
6346014-34601490.66191.29
60min1331821-33182186.94292.554.2387.7093.344.22
2355377-35537793.11493.90
3352676-35267692.40693.19
4377605-37760598.93899.78
5346281-34628190.73191.50
6355651-35565193.18693.96
极限1355437-35543793.13094.042.1594.0394.982.17
2358430-35843093.91494.85
3355232-35523293.07694.01
4374283-37428398.06799.08
5353453-35345392.61093.53
6356583-35658393.43094.36
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493822043813673820403810943808863815180.16
214.403804213816383810300.23
单位质量响应值RSD%判断
26329.7426460.420.36数据可信
供试品溶液-2026032521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%
5min1236174-23617461.78860.525.1361.7960.525.14
2214873-21487356.21556.21
3224476-22447658.72758.73
4231233-23123360.49560.49
5230816-23081660.38660.39
6250369-25036965.50165.50
10min1295189-29518977.22775.223.7077.3375.323.70
2279212-27921273.04773.14
3276746-27674672.40272.50
4286560-28656074.97075.07
5282584-28258473.92974.03
6304707-30470779.71779.83
15min1320157-32015783.75980.803.7983.9981.023.79
2301709-30170978.93379.15
3295387-29538777.27977.50
4303934-30393479.51579.74
5305903-30590380.03080.25
6325911-32591185.26585.51
20min1331009-33100986.59883.613.6386.9783.973.63
2314531-31453182.28782.63
3305318-30531879.87780.22
4313360-31336081.98182.34
5317368-31736883.03083.39
6335891-33589187.87688.26
30min1346147-34614790.55987.243.1791.0787.743.17
2328426-32842685.92386.41
3322110-32211084.27084.75
4325140-32514085.06385.56
5332379-33237986.95787.45
6346564-34656490.66891.20
45min1349084-34908491.32790.112.5191.9990.762.52
2344227-34422790.05690.68
3337739-33773988.35988.98
4331902-33190286.83287.47
5347377-34737790.88091.52
6356321-35632193.22093.90
60min1348515-34851591.17891.891.6992.0092.691.69
2349162-34916291.34792.12
3344055-34405590.01190.78
4349760-34976091.50492.29
5355032-35503292.88393.68
6360961-36096194.43495.27
极限1355640-35564093.04293.441.1594.0194.391.16
2356100-35610093.16394.09
3359762-35976294.12195.04
4350513-35051391.70192.63
5358448-35844893.77794.72
6362476-36247694.83195.83
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