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%
110.082262422790227632267322864227430.42
210.092186021759218100.33
单位质量响应值RSD%判断
2256.252161.553.04数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25011201批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15494-549422.33722.801.8322.3422.801.82
25691-569123.13823.14
35641-564122.93522.93
10min16703-670327.25223.7517.8127.2923.7917.78
24686-468619.05219.09
36136-613624.94724.99
15min112420-1242050.49650.610.2050.5850.690.19
212465-1246550.67950.75
312458-1245850.65150.73
20min112610-1261051.26949.604.9251.4449.764.91
211511-1151146.80046.96
312474-1247450.71650.88
30min116292-1629266.23866.011.0366.4966.251.01
216366-1636666.53966.77
316048-1604865.24665.50
45min115769-1576964.11264.622.9964.4764.972.98
215493-1549362.99063.33
316416-1641666.74367.10
60min117527-1752771.26071.700.9171.7372.160.91
217557-1755771.38271.83
317818-1781872.44372.91
极限117876-1787672.67970.842.2873.2771.432.27
217264-1726470.19070.76
317133-1713369.65870.25
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%
110.082258122664227322261222522226220.36
210.092114021117211280.08
单位质量响应值RSD%判断
2244.252093.954.90数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25011301批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17062-706229.26032.2815.7429.2632.2815.74
29205-920538.14038.14
37103-710329.43029.43
10min18925-892536.98036.456.4037.0336.506.42
29283-928338.46338.53
38180-818033.89333.94
15min111392-1139247.20155.2612.7247.3155.3712.71
214507-1450760.10860.24
314110-1411058.46358.57
20min114401-1440159.66958.022.7559.8658.232.72
213972-1397257.89158.12
313635-1363556.49556.70
30min115432-1543263.94068.236.0764.2368.546.07
217424-1742472.19472.52
316548-1654868.56568.86
45min117481-1748172.43070.453.4672.8370.873.44
217180-1718071.18371.63
316347-1634767.73268.14
60min116529-1652968.48673.586.0469.0074.126.02
218488-1848876.60377.17
318259-1825975.65476.18
极限118744-1874477.66374.743.4178.2975.403.35
217764-1776473.60374.29
317611-1761172.96973.62
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%
110.082120121404213662127521403213300.42
210.092131821279212980.13
单位质量响应值RSD%判断
2116.072110.800.18数据可信
供试品溶液批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15280-528022.42626.9814.9722.4326.9814.97
26678-667828.36428.36
37095-709530.13530.14
10min17142-714230.33528.387.0430.3728.427.01
26203-620326.34726.39
36698-669828.44928.50
15min112444-1244452.85552.282.3552.9452.372.35
211977-1197750.87150.96
312504-1250453.10953.21
20min112812-1281254.41854.450.2954.5954.630.28
212859-1285954.61754.79
312788-1278854.31654.50
30min116204-1620468.82567.861.4869.0968.131.47
215996-1599667.94168.21
315733-1573366.82467.10
45min115710-1571066.72766.091.3467.1166.471.33
215323-1532365.08365.46
315644-1564466.44666.83
60min118508-1850878.61177.081.7579.1077.571.74
217912-1791276.07976.57
318024-1802476.55577.05
极限117567-1756774.61473.391.4575.2474.011.44
217148-1714872.83473.45
317121-1712172.72073.35
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