佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
110.392169221325215202149821479215030.61
210.402158621690216380.34
单位质量响应值RSD%判断
2069.592080.580.38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%
5min113057-1305756.48456.5212.9256.4856.5212.92
213246-1324657.30157.30
310375-1037544.88244.88
412209-1220952.81552.82
515270-1527066.05766.06
614240-1424061.60161.60
10min119178-1917882.96385.505.5683.2885.825.58
219968-1996886.38086.70
317852-1785277.22777.48
420325-2032587.92588.22
520912-2091290.46490.83
620355-2035588.05488.40
15min122046-2204695.37095.374.0996.1496.164.13
222038-2203895.33596.13
320492-2049288.64789.33
421948-2194894.94695.73
523237-23237100.522101.39
622517-2251797.40798.24
20min122445-2244597.09697.603.1998.4098.923.24
222524-2252497.43798.77
321323-2132392.24293.41
422534-2253497.48198.79
523400-23400101.227102.65
623141-23141100.106101.48
30min122585-2258597.70198.702.2499.55100.572.29
222568-2256897.62899.50
322065-2206595.45297.14
422960-2296099.323101.17
523298-23298100.786102.78
623425-23425101.335103.26
45min122980-2298099.41099.882.00101.80102.282.05
222701-2270198.203100.61
322518-2251897.41199.62
423166-23166100.215102.62
523785-23785102.892105.44
623375-23375101.119103.61
60min122752-2275298.42499.741.59101.36102.701.63
222647-2264797.969100.93
322847-2284798.835101.59
423159-23159100.184103.14
523549-23549101.871104.99
623383-23383101.153104.21
90min122841-2284198.80999.751.37102.29103.261.41
222691-2269198.160101.66
322967-2296799.354102.66
422976-2297699.393102.91
523511-23511101.707105.39
623359-23359101.049104.66
极限122930-2293099.19499.671.40103.23103.741.42
222602-2260297.775101.82
323057-2305799.743103.60
422876-2287698.960103.03
523534-23534101.806106.06
623235-23235100.513104.69
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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%
110.392166321571215542160021449215670.37
210.402163221545215880.29
单位质量响应值RSD%判断
2075.752075.770.01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%
5min117576-1757676.00771.3214.4376.0171.3214.43
211715-1171550.66150.66
316600-1660071.78771.79
417630-1763076.24176.24
517751-1775176.76476.76
617683-1768376.47076.47
10min121464-2146492.82188.088.2593.2488.488.27
217008-1700873.55173.83
320726-2072689.62990.03
420896-2089690.36590.79
520719-2071989.59990.03
621400-2140092.54492.97
15min123023-2302399.56394.274.41100.5095.164.45
220197-2019787.34288.03
321582-2158293.33194.23
422485-2248597.23698.16
521839-2183994.44395.37
621668-2166893.70394.64
20min123465-23465101.47496.942.80102.9798.352.85
221594-2159493.38394.56
322591-2259197.69599.11
422468-2246897.16398.63
522032-2203295.27796.73
622344-2234496.62698.09
30min123634-23634102.20596.793.71104.2698.743.66
222388-2238896.81798.51
321852-2185294.49996.46
422595-2259597.71299.72
521171-2117191.55493.53
622650-2265097.95099.95
45min123573-23573101.94197.832.30104.56100.312.26
222881-2288198.949101.18
322225-2222596.11298.59
422353-2235396.66599.21
522338-2233896.60199.09
622363-2236396.70999.25
60min123177-23177100.22996.562.77103.4299.592.67
222937-2293799.191101.97
322054-2205495.37298.39
421617-2161793.48396.57
522347-2234796.63999.66
621839-2183994.44397.52
90min123269-23269100.62796.692.66104.37100.262.58
222901-2290199.035102.37
322039-2203995.30898.85
421830-2183094.40498.01
521860-2186094.53398.09
622259-2225996.25999.86
极限123146-23146100.09596.592.09104.40100.692.05
222632-2263297.872101.75
322102-2210295.58099.66
422036-2203695.29599.42
522167-2216795.86199.95
621924-2192494.81098.95
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