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%
110.002119121322211652126721245212380.30
210.082125821077211680.61
单位质量响应值RSD%判断
2123.802100.000.80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%
5min117313-1731373.59162.9413.7873.5962.9413.78
211728-1172849.85149.85
313097-1309755.67055.67
415840-1584067.33067.33
515791-1579167.12267.12
615074-1507464.07464.07
10min121098-2109889.68085.688.0489.8085.788.04
217154-1715472.91573.00
319521-1952182.97683.07
421267-2126790.39890.51
521341-2134190.71290.82
620563-2056387.40687.51
15min122010-2201093.55692.036.6693.8392.276.67
218919-1891980.41780.62
321451-2145191.18091.41
422356-2235695.02795.29
523090-2309098.14798.41
622075-2207593.83294.08
20min122545-2254595.83095.104.7296.2695.504.73
220362-2036286.55186.89
322541-2254195.81396.20
423058-2305898.01198.43
523365-2336599.31699.74
622362-2236295.05295.46
30min122817-2281796.98697.492.4597.5798.052.47
222126-2212694.04994.53
323002-2300297.77398.32
423257-2325798.85799.44
523777-23777101.067101.66
622638-2263896.22696.79
45min122958-2295897.58698.152.0798.3498.882.08
222649-2264996.27296.91
323177-2317798.51799.22
423283-2328398.96799.72
523886-23886101.530102.29
622597-2259796.05196.78
60min123253-2325398.84098.371.9099.7599.261.91
222738-2273896.65197.45
323241-2324198.78999.66
423267-2326798.89999.81
523795-23795101.144102.07
622564-2256495.91196.80
90min123368-2336899.32898.701.96100.4199.741.98
222693-2269396.45997.42
323417-2341799.537100.57
423291-2329199.001100.08
523858-23858101.411102.51
622687-2268796.43497.48
极限123333-2333399.18098.341.92100.4299.551.93
222721-2272196.57897.70
323254-2325498.844100.04
423356-2335699.277100.52
523663-23663100.582101.85
622482-2248295.56296.77
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%
110.002132021274212312112221145212180.40
210.082122421211212180.05
单位质量响应值RSD%判断
2121.802104.960.57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%
5min117503-1750374.34558.6414.2974.3558.6414.29
213073-1307355.52955.53
312562-1256253.35853.36
413636-1363657.92057.92
511923-1192350.64450.64
614140-1414060.06160.06
10min121518-2151891.39985.535.0991.5285.635.09
219865-1986584.37884.47
319215-1921581.61781.71
420625-2062587.60687.70
518814-1881479.91480.00
620783-2078388.27788.38
15min122704-2270496.43794.362.1496.7194.602.15
222062-2206293.71093.94
322044-2204493.63493.86
422749-2274996.62896.87
521474-2147491.21291.43
622260-2226094.55194.80
20min122861-2286197.10497.001.2597.5497.401.26
222855-2285597.07897.47
322889-2288997.22397.60
423188-2318898.49398.90
522313-2231394.77695.15
622912-2291297.32097.73
30min123134-2313498.26398.450.7998.8699.010.79
223372-2337299.27499.83
323155-2315598.35398.90
423416-2341699.461100.03
522974-2297497.58498.11
623013-2301397.74998.32
45min123261-2326198.80398.320.8299.5799.050.83
223202-2320298.55299.27
323281-2328198.88899.59
423320-2332099.05399.79
522874-2287497.15997.85
622949-2294997.47898.21
60min123125-2312598.22598.560.8699.1599.450.86
223438-2343899.555100.44
323208-2320898.57899.45
423441-2344199.567100.47
523042-2304297.87398.72
622976-2297697.59298.48
90min123338-2333899.13098.421.10100.2299.481.11
223264-2326498.81699.86
323312-2331299.019100.06
423348-2334899.172100.24
522696-2269696.40397.42
623071-2307197.99699.05
极限123190-2319098.50198.020.8299.7699.240.83
223159-2315998.37099.58
323223-2322398.64199.84
423166-2316698.39999.63
522723-2272396.51897.69
623006-2300697.72098.94
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