非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972636962638392637032637742635072637040.05
211.172711032706122708580.13
单位质量响应值RSD%判断
24038.6524248.700.62数据可信
供试品溶液-3788B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%
5min1189872-18987270.70964.6712.3670.7164.6712.36
2176858-17685865.86265.86
3196671-19667173.24173.24
4149747-14974755.76655.77
5144962-14496253.98453.98
6183824-18382468.45768.46
10min1239969-23996989.36589.021.9889.4889.131.99
2241053-24105389.76989.88
3242891-24289190.45390.58
4231405-23140586.17686.27
5235390-23539087.66087.75
6243564-24356490.70490.82
15min1254408-25440894.74294.831.3895.0195.091.39
2255389-25538995.10895.37
3254075-25407594.61894.89
4251341-25134193.60093.84
5251626-25162693.70693.94
6261022-26102297.20597.47
20min1263421-26342198.09996.661.5198.5297.071.51
2260616-26061697.05497.47
3256559-25655995.54395.97
4256247-25624795.42795.82
5255806-25580695.26395.66
6264643-26464398.55498.98
30min1264177-26417798.38097.531.3098.9798.101.30
2262938-26293897.91998.50
3258288-25828896.18796.78
4259116-25911696.49597.05
5259798-25979896.74997.30
6266986-26698699.426100.02
45min1263547-26354798.14697.291.5098.9098.021.50
2262814-26281497.87398.62
3256687-25668795.59196.34
4260252-26025296.91997.63
5257285-25728595.81496.53
6266839-26683999.372100.13
60min1264404-26440498.46597.231.5299.3898.131.53
2263182-26318298.01098.92
3256187-25618795.40596.31
4259574-25957496.66697.54
5257291-25729195.81696.69
6265823-26582398.99399.92
90min1264657-26465798.55997.001.5599.6498.061.55
2261348-26134897.32798.40
3254965-25496594.95096.02
4259034-25903496.46597.50
5257599-25759995.93196.96
6265175-26517598.75299.84
极限1262363-26236397.70596.511.2198.9597.741.21
2260397-26039796.97398.20
3255274-25527495.06596.29
4258700-25870096.34197.54
5255816-25581695.26796.46
6262388-26238897.71498.97
非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.975385355387505391905378965374745383690.13
211.175476005470025473010.08
单位质量响应值RSD%判断
49076.4848997.400.12数据可信
供试品溶液-4229B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%
5min1351677-35167764.48155.0322.4564.4855.0322.45
2328054-32805460.14960.15
3328812-32881260.28860.29
4170914-17091431.33731.34
5283134-28313451.91351.91
6338148-33814862.00062.00
10min1477524-47752487.55585.395.7087.6685.485.71
2481118-48111888.21488.31
3473733-47373386.86086.96
4412464-41246475.62675.68
5468729-46872985.94286.03
6480848-48084888.16488.27
15min1513424-51342494.13793.201.9494.3993.431.97
2512695-51269594.00394.25
3506384-50638492.84693.09
4489313-48931389.71689.89
5511887-51188793.85594.09
6516106-51610694.62994.88
20min1522095-52209595.72795.851.4196.1496.241.41
2523225-52322595.93496.34
3514995-51499594.42594.83
4514304-51430494.29994.63
5530004-53000497.17797.56
6531897-53189797.52497.93
30min1531502-53150297.45297.011.3298.0297.561.32
2529101-52910197.01297.58
3517624-51762494.90795.46
4525740-52574096.39596.88
5532311-53231197.60098.15
6538199-53819998.68099.25
45min1530261-53026197.22497.041.1797.9697.751.17
2526250-52625096.48997.21
3520583-52058395.45096.17
4527506-52750696.71997.36
5531704-53170497.48998.20
6539097-53909798.84499.58
60min1531300-53130097.41596.951.4898.3197.821.48
2528073-52807396.82397.71
3515334-51533494.48795.36
4527410-52741096.70297.51
5531366-53136697.42798.30
6539185-53918598.86099.76
90min1533043-53304397.73496.801.3798.7997.831.37
2525315-52531596.31797.37
3516586-51658694.71795.75
4525627-52562796.37597.34
5529649-52964997.11298.15
6537435-53743598.54099.60
极限1527088-52708896.64296.091.3397.8697.281.32
2523369-52336995.96197.17
3511780-51178093.83695.03
4523545-52354595.99397.12
5525813-52581396.40997.61
6532776-53277697.68598.91
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