佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.262161221382215462138621430214710.48
2 10.282150221602215520.33
单位质量响应值RSD%判断
2092.692096.500.13数据可信
供试品溶液-2025041421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%
5min113431-1343157.56054.9616.2757.5654.9616.27
211962-1196251.26451.26
311963-1196351.26951.27
416781-1678171.91771.92
511730-1173050.27050.27
611078-1107847.47647.48
10min122234-2223495.28688.026.3395.3888.126.34
219833-1983384.99685.08
320897-2089789.55689.64
421704-2170493.01593.13
519756-1975684.66684.75
618814-1881480.62980.71
15min122470-2247096.29896.412.3596.5596.642.37
222752-2275297.50697.73
322709-2270997.32297.56
423228-2322899.54699.82
522076-2207694.60994.83
621739-2173993.16593.38
20min122936-2293698.29598.181.9098.7198.581.90
223455-23455100.519100.91
322658-2265897.10397.50
423221-2322199.51699.96
522971-2297198.44598.83
622218-2221895.21895.59
30min122887-2288798.08599.132.0098.6699.702.00
223736-23736101.723102.28
322862-2286297.97898.54
423544-23544100.900101.51
523248-2324899.632100.18
622515-2251596.49097.02
45min122804-2280497.72999.041.5498.4799.771.55
223323-2332399.953100.68
323102-2310299.00699.73
423704-23704101.586102.36
522946-2294698.33899.05
622781-2278197.63098.32
60min122588-2258896.80398.672.0497.7199.572.04
223447-23447100.485101.38
323118-2311899.07599.96
423639-23639101.307102.25
522447-2244796.19997.08
622906-2290698.16699.02
90min122672-2267297.16398.672.0598.2399.722.05
223605-23605101.162102.22
323037-2303798.72899.78
423562-23562100.977102.09
522478-2247896.33297.37
622781-2278197.63098.65
极限122670-2267097.15598.672.1198.3899.892.11
223503-23503100.725101.95
323001-2300198.57399.79
423725-23725101.676102.96
522592-2259296.82098.02
622649-2264997.06598.24
佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.262159721496214262149321542215110.30
2 10.282167321472215720.66
单位质量响应值RSD%判断
2096.592098.440.07数据可信
供试品溶液-PN4A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%
5min113966-1396659.76945.5129.7259.7745.5229.72
29155-915539.18039.18
38558-855836.62536.63
48456-845636.18936.19
515351-1535165.69765.70
68322-832235.61535.62
10min121944-2194493.91283.678.7494.0183.748.75
218817-1881780.53080.60
318904-1890480.90280.96
417444-1744474.65474.71
521289-2128991.10991.22
618901-1890180.88980.95
15min123000-2300098.43295.422.3198.6995.632.30
222102-2210294.58894.79
322124-2212494.68394.88
422331-2233195.56995.75
521524-2152492.11592.38
622691-2269197.10997.30
20min123109-2310998.89897.051.6099.3297.431.61
222296-2229695.41995.78
322474-2247496.18096.53
422508-2250896.32696.67
522526-2252696.40396.82
623156-2315699.09999.46
30min123379-23379100.05497.871.30100.6498.411.31
222795-2279597.55498.07
322720-2272097.23397.75
422526-2252696.40396.91
522775-2277597.46998.04
623020-2302098.51799.04
45min123433-23433100.28597.281.55101.0497.981.57
222540-2254096.46397.14
322637-2263796.87897.55
422493-2249396.26296.93
522694-2269497.12297.86
622585-2258596.65697.34
60min123115-2311598.92496.981.2699.8497.841.26
222492-2249296.25897.10
322395-2239595.84296.68
422807-2280797.60698.43
522398-2239895.85596.76
622753-2275397.37598.22
90min123237-2323799.44697.151.49100.5398.171.50
222592-2259296.68597.69
322210-2221095.05196.05
422783-2278397.50398.49
522588-2258896.66897.73
622793-2279397.54698.55
极限123426-23426100.25597.451.91101.5098.631.92
222403-2240395.87797.04
322246-2224695.20596.36
422674-2267497.03698.19
522793-2279397.54698.77
623079-2307998.77099.94
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