厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.266326463321632816344763647633920.26
210.296290063142630210.28
单位质量响应值RSD%判断
6178.566124.490.63数据可信
供试品溶液-BJ86589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%
5min17197-719710.52113.0152.7510.5213.0152.73
28294-829412.12512.13
36801-68019.9429.94
46373-63739.3179.32
518362-1836226.84426.84
66352-63529.2869.29
10min120654-2065430.19432.3324.8730.3132.4825.00
221008-2100830.71230.85
320838-2083830.46330.57
418237-1823726.66126.76
533100-3310048.38948.69
618872-1887227.58927.69
15min128584-2858441.78742.9018.7642.2443.4018.93
227946-2794640.85541.33
328224-2822441.26141.71
425135-2513536.74537.14
540231-4023158.81459.65
625954-2595437.94238.35
20min134607-3460750.59250.7115.3851.5151.6915.58
233757-3375749.35050.28
332779-3277947.92048.83
430494-3049444.57945.39
545127-4512765.97267.46
631346-3134645.82546.66
30min142666-4266662.37461.289.1863.8562.839.47
241019-4101959.96661.44
339839-3983958.24159.68
437884-3788455.38356.69
549080-4908071.75173.97
641036-4103659.99161.33
45min152333-5233376.50673.967.7278.6876.187.97
250063-5006373.18875.33
347486-4748669.42071.51
446270-4627067.64369.56
557246-5724683.68886.71
650131-5013173.28775.29
60min155810-5581081.58982.566.2484.6185.606.50
257762-5776284.44387.40
354097-5409779.08581.94
451947-5194775.94278.61
562266-6226691.02794.98
656957-5695783.26686.09
90min169534-69534101.65291.986.37105.5895.946.29
262593-6259391.50595.40
359088-5908886.38190.12
458487-5848785.50389.02
563788-6378893.25298.21
664015-6401593.58497.33
120min164743-6474394.64893.142.5699.7198.122.29
266171-6617196.736101.65
363033-6303392.14996.85
464193-6419393.84498.31
561978-6197890.60696.60
662135-6213590.83695.62
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限165563-6556395.84794.022.11101.96100.041.68
265229-6522995.359101.35
364665-6466594.534100.26
465078-6507895.138100.65
562091-6209190.77197.78
663253-6325392.47098.27
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