氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.161436226143718814373721437058143854714372780.06
211.211447701144753114476160.01
单位质量响应值RSD%判断
128788.35129136.130.20数据可信
长期6月-供试品溶液-X0734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%
240min1538895-53889537.05032.767.2437.0532.767.25
2461265-46126531.71331.71
3479448-47944832.96332.96
4469352-46935232.26932.27
5475599-47559932.69932.70
6434492-43449229.87229.87
480min11009958-100995869.43763.864.7069.4963.914.70
2933129-93312964.15564.20
3935234-93523464.30064.35
4893466-89346661.42861.48
5903665-90366562.12962.18
6897698-89769861.71961.76
720min11412272-141227297.09790.955.4097.2691.105.40
21313162-131316290.28390.43
31348324-134832492.70192.85
41201523-120152382.60882.75
51361622-136162293.61593.76
61300536-130053689.41589.55
960min11520773-1520773104.557103.231.38104.86103.521.39
21495134-1495134102.794103.07
31502058-1502058103.270103.56
41473065-1473065101.277101.54
51488951-1488951102.369102.65
61529172-1529172105.134105.41
1200min11512269-1512269103.972103.060.94104.43103.500.94
21488393-1488393102.331102.76
31497467-1497467102.955103.39
41492015-1492015102.580103.00
51484304-1484304102.050102.49
61519843-1519843104.493104.92
1440min11506007-1506007103.542102.671.04104.16103.261.04
21481486-1481486101.856102.44
31489256-1489256102.390102.98
41483733-1483733102.010102.58
51480650-1480650101.798102.39
61518452-1518452104.397104.98
极限11505163-1505163103.484102.481.09104.26103.221.09
21479202-1479202101.699102.44
31483324-1483324101.982102.73
41482261-1482261101.909102.63
51476974-1476974101.546102.29
61516361-1516361104.254105.00
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.161432447143434114347321434901143448214341810.07
211.211451060145077014509150.02
单位质量响应值RSD%判断
128510.84129430.420.51数据可信
长期6月-供试品溶液-X0734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%
240min1461222-46122231.70831.567.2131.7131.567.21
2479144-47914432.94132.94
3475113-47511332.66332.66
4394256-39425627.10527.10
5461358-46135831.71831.72
6483528-48352833.24233.24
480min1928334-92833463.82261.935.4163.8761.985.42
2918267-91826763.13063.18
3932800-93280064.12964.18
4803995-80399555.27455.31
5921041-92104163.32063.37
6900180-90018061.88661.94
720min11420512-142051297.65889.055.7897.8089.205.78
21306375-130637589.81289.96
31297688-129768889.21489.36
41187031-118703181.60781.73
51283285-128328588.22488.37
61277262-127726287.81087.95
960min11475384-1475384101.431101.570.74101.72101.840.75
21495266-1495266102.798103.08
31480689-1480689101.796102.07
41465769-1465769100.770101.02
51466574-1466574100.825101.10
61480683-1480683101.795102.07
1200min11468792-1468792100.978101.340.73101.42101.770.73
21493097-1493097102.649103.08
31475431-1475431101.434101.87
41469385-1469385101.018101.42
51461645-1461645100.486100.91
61476196-1476196101.487101.91
1440min11462980-1462980100.578100.990.77101.17101.560.78
21488418-1488418102.327102.91
31469010-1469010100.993101.58
41461469-1461469100.474101.02
51457301-1457301100.188100.76
61474534-1474534101.372101.95
极限11467211-1467211100.869100.790.70101.61101.520.70
21482100-1482100101.893102.63
31464757-1464757100.700101.44
41461568-1461568100.481101.18
51451150-145115099.765100.49
61469562-1469562101.031101.76
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