非奈利酮片项目信息
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1000
标示量(mg)10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%
1 11.141907551895331887481891081892711894830.41
2 11.111903911902641903280.05
单位质量响应值RSD%判断
17009.2517131.230.51数据可信
供试品溶液-1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%
5min131751-3175116.72722.6819.9116.7322.6819.91
248220-4822025.40325.40
337401-3740119.70419.70
445368-4536823.90123.90
555865-5586529.43129.43
639687-3968720.90820.91
10min176553-7655340.33047.108.9240.3647.148.92
295500-9550050.31150.35
386572-8657245.60845.64
495058-9505850.07850.12
597196-9719651.20551.25
685598-8559845.09545.13
15min1103860-10386054.71559.974.8354.8160.094.84
2118062-11806262.19762.32
3113669-11366959.88359.99
4117759-11775962.03862.16
5117650-11765061.98062.11
6112033-11203359.02159.13
20min1121071-12107163.78269.234.1263.9769.454.13
2135442-13544271.35371.58
3133315-13331570.23370.44
4134794-13479471.01271.24
5133907-13390770.54570.78
6129995-12999568.48468.69
30min1143479-14347975.58778.712.2775.8879.042.29
2152507-15250780.34380.69
3152040-15204080.09780.42
4150682-15068279.38279.73
5150231-15023179.14479.50
6147530-14753077.72278.04
45min1157890-15789083.17985.672.2583.6086.142.26
2167341-16734188.15888.64
3165571-16557187.22687.69
4163462-16346286.11586.59
5162387-16238785.54886.04
6159084-15908483.80884.26
60min1167476-16747688.22989.372.1288.7989.972.12
2174214-17421491.77992.41
3174009-17400991.67192.28
4169076-16907689.07289.69
5166740-16674087.84288.47
6166291-16629187.60588.20
极限1176197-17619792.82492.931.8493.5393.691.84
2179765-17976594.70395.49
3178672-17867294.12894.89
4178609-17860994.09494.86
5173534-17353491.42192.20
6171626-17162690.41691.15
非奈利酮片项目信息
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1000
标示量(mg)10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%
1 11.141891201888911892611897531892961892640.17
2 11.111898521898711898620.01
单位质量响应值RSD%判断
16989.5917089.290.42数据可信
供试品溶液-2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%
5min138385-3838520.25821.687.9920.2621.687.99
244371-4437123.41823.42
345194-4519423.85223.85
437511-3751119.79719.80
538849-3884920.50320.50
642121-4212122.23022.23
10min1100411-10041152.99448.838.8353.0348.878.83
291405-9140548.24148.28
3101072-10107253.34353.38
478555-7855541.45941.49
592492-9249248.81448.85
691220-9122048.14348.18
15min1126747-12674766.89362.526.8467.0262.646.84
2116092-11609261.27061.39
3128546-12854667.84367.97
4106458-10645856.18556.29
5116939-11693961.71761.83
6116035-11603561.24061.36
20min1140897-14089774.36170.364.9474.5970.584.95
2132204-13220469.77369.99
3139753-13975373.75774.00
4122887-12288764.85665.05
5133668-13366870.54670.76
6130513-13051368.88169.10
30min1155982-15598282.32279.073.1382.6879.413.14
2151547-15154779.98280.32
3153320-15332080.91781.28
4143159-14315975.55575.86
5148118-14811878.17278.51
6146832-14683277.49377.83
45min1167572-16757288.43986.372.2188.9386.842.22
2165595-16559587.39687.87
3164237-16423786.67987.18
4158875-15887583.84984.28
5166075-16607587.64988.12
6159526-15952684.19384.66
60min1173617-17361791.63089.421.9892.2790.031.98
2173234-17323491.42792.04
3169628-16962889.52490.17
4166564-16656487.90788.48
5167542-16754288.42389.04
6165975-16597587.59688.20
极限1176696-17669693.25591.971.2594.0592.741.26
2177070-17707093.45294.22
3173683-17368391.66492.46
4172204-17220490.88491.60
5173958-17395891.81092.57
6172015-17201590.78491.53
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