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)0
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%
110.843659253680743655643686273658493668080.39
210.813721213707373714290.27
单位质量响应值RSD%判断
33838.3834359.761.09数据可信
供试品溶液-2025083121批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1200442-20044252.86550.495.0052.8650.495.00
2203496-20349653.67053.67
3187528-18752849.45949.46
4193667-19366751.07851.08
5185255-18525548.85948.86
6178305-17830547.02647.03
10min1262941-26294169.34868.691.4369.4468.771.43
2264319-26431969.71269.80
3258635-25863568.21368.30
4260206-26020668.62768.71
5262399-26239969.20569.29
6254106-25410667.01867.10
15min1287918-28791875.93675.900.5776.1476.100.57
2289697-28969776.40576.61
3286579-28657975.58375.78
4289735-28973576.41576.61
5286192-28619275.48175.68
6286534-28653475.57175.76
20min1303152-30315279.95480.010.7380.2880.330.73
2304030-30403080.18580.52
3302331-30233179.73780.06
4304127-30412780.21180.54
5306548-30654880.84981.17
6299947-29994779.10879.42
30min1320014-32001484.40184.430.7184.8684.890.71
2321619-32161984.82485.29
3317837-31783783.82784.28
4321357-32135784.75585.22
5322841-32284185.14685.60
6317109-31710983.63584.08
45min1331420-33142087.40987.900.7788.0188.500.77
2334881-33488188.32288.93
3331561-33156187.44688.04
4333557-33355787.97388.57
5337440-33744088.99789.60
6330794-33079487.24487.83
60min1340993-34099389.93490.050.5890.6890.800.58
2341965-34196590.19090.95
3338110-33811089.17489.91
4343153-34315390.50491.25
5343531-34353190.60391.35
6340889-34088989.90690.64
极限1341090-34109089.95990.830.9790.8691.720.96
2347028-34702891.52692.43
3341579-34157990.08890.98
4344373-34437390.82591.72
5349518-34951892.18293.08
6342681-34268190.37991.26
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)0
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%
110.843729653721613711093715783705163716660.26
210.813725563713373719460.24
单位质量响应值RSD%判断
34286.5334407.590.25数据可信
供试品溶液-2025083121批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1285519-28551974.75577.876.7974.7677.876.79
2261526-26152668.47368.47
3308223-30822380.70080.70
4306345-30634580.20880.21
5314568-31456882.36182.36
6308276-30827680.71480.71
10min1347358-34735890.94690.601.3491.0790.731.35
2337457-33745788.35488.47
3345244-34524490.39390.53
4346430-34643090.70390.84
5350825-35082591.85491.99
6348869-34886991.34291.48
15min1360217-36021794.31393.820.7794.5994.100.78
2353965-35396592.67692.94
3356049-35604993.22293.51
4358888-35888893.96594.25
5359913-35991394.23394.52
6361004-36100494.51994.81
20min1363853-36385395.26595.130.5095.7095.560.50
2364166-36416695.34795.76
3359942-35994294.24194.68
4362753-36275394.97795.42
5364923-36492395.54595.99
6364363-36436395.39895.84
30min1368804-36880496.56195.980.6397.1596.580.63
2366326-36632695.91296.49
3362448-36244894.89795.49
4366377-36637795.92696.53
5368599-36859996.50797.11
6366959-36695996.07896.68
45min1372741-37274197.59297.110.7198.3497.870.70
2372513-37251397.53298.27
3365802-36580295.77596.53
4372258-37225897.46598.23
5370756-37075697.07297.84
6371412-37141297.24498.01
60min1375042-37504298.19497.520.5599.1198.430.55
2371799-37179997.34598.24
3369127-36912796.64697.56
4372286-37228697.47398.39
5374059-37405997.93798.87
6372399-37239997.50298.43
极限1375144-37514498.22197.390.7399.3098.460.72
2372694-37269497.58098.64
3367635-36763596.25597.33
4373842-37384297.88098.96
5370211-37021196.93098.02
6372185-37218597.44698.53
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