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%
110.002102221201210212103720903210370.51
210.102104521036210400.04
单位质量响应值RSD%判断
2103.702083.170.70数据可信
供试品溶液-2025031821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%
5min19403-940340.32161.5517.1340.3261.5517.14
215362-1536265.87465.87
314588-1458862.55562.55
415797-1579767.73967.74
515522-1552266.56066.56
615447-1544766.23866.24
10min116647-1664771.38486.859.2071.4586.959.21
220677-2067788.66588.77
320308-2030887.08287.19
421953-2195394.13694.25
521321-2132191.42691.54
620615-2061588.39988.51
15min119614-1961484.10694.065.9384.2994.315.95
221874-2187493.79794.06
322422-2242296.14796.40
423544-23544100.959101.23
522384-2238495.98496.25
621770-2177093.35293.61
20min121576-2157692.52097.663.9792.8598.073.98
222364-2236495.89996.31
323398-23398100.333100.74
424113-24113103.399103.84
522940-2294098.36998.79
622262-2226295.46195.87
30min122747-2274797.54199.122.9198.0299.682.92
222716-2271697.40897.98
323046-2304698.82399.40
424317-24317104.273104.88
523408-23408100.375100.96
622458-2245896.30296.87
45min123129-2312999.17999.743.0899.82100.473.08
222767-2276797.62798.36
323148-2314899.261100.00
424610-24610105.530106.31
523318-2331899.989100.74
622585-2258596.84697.58
60min123250-2325099.698100.612.79100.51101.512.80
223010-2301098.66999.57
323477-23477100.671101.58
424645-24645105.680106.64
523619-23619101.280102.20
622779-2277997.67898.57
90min123141-2314199.23099.732.82100.21100.802.83
222724-2272497.44298.51
323289-2328999.865100.94
424480-24480104.972106.11
523251-2325199.702100.79
622660-2266097.16898.23
极限123376-23376100.238100.083.31101.38101.313.30
222549-2254996.69297.92
323283-2328399.839101.08
424776-24776106.242107.55
523228-2322899.604100.86
622824-2282497.87199.09
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%
110.002126621092212772124321149212050.39
210.102091121023209670.38
单位质量响应值RSD%判断
2120.502075.941.51数据可信
供试品溶液-2025031821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%
5min115365-1536565.74259.907.8665.7459.907.86
214498-1449862.03262.03
314665-1466562.74762.75
412682-1268254.26254.26
512679-1267954.24954.25
614110-1411060.37260.37
10min120452-2045287.50885.473.3487.6285.573.34
219332-1933282.71582.82
319497-1949783.42183.53
419604-1960483.87983.97
519895-1989585.12485.21
621074-2107490.16990.27
15min122376-2237695.74094.832.2496.0095.082.24
221401-2140191.56891.81
321940-2194093.87494.12
422170-2217094.85895.09
522190-2219094.94495.18
622906-2290698.00798.26
20min123042-2304298.58997.461.3199.0097.861.31
222575-2257596.59196.99
322327-2232795.53095.93
422684-2268497.05897.45
523039-2303998.57698.97
623001-2300198.41498.83
30min122877-2287797.88398.750.8198.4699.310.80
223026-2302698.52199.08
322903-2290397.99598.55
423369-2336999.988100.54
523186-2318699.20599.76
623114-2311498.89799.48
45min122944-2294498.17099.260.7398.9199.990.72
223360-2336099.950100.67
323062-2306298.67599.40
423345-2334599.886100.60
523303-2330399.706100.43
623176-2317699.16399.91
60min122928-2292898.10299.230.8899.01100.120.87
223336-2333699.847100.73
322979-2297998.32099.21
423437-23437100.279101.16
523298-2329899.685100.57
623173-2317399.150100.06
90min122840-2284097.72599.391.8498.79100.451.82
223890-23890102.218103.27
322713-2271397.18298.23
423311-2331199.740100.79
523189-2318999.218100.27
623437-23437100.279101.35
极限122852-2285297.77698.981.2999.01100.201.27
223456-23456100.361101.58
323075-2307598.73199.94
423403-23403100.134101.35
523281-2328199.612100.83
622732-2273297.26398.50
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