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500
标示量(mg)20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%
111.053778883779863775343777613771533776640.09
211.123793513793553793530.01
单位质量响应值RSD%判断
34177.7434114.480.14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%
5min141158-4115810.8398.4525.5610.848.4525.56
224740-247406.5166.52
321427-214275.6435.64
430054-300547.9157.92
540894-4089410.77010.77
634287-342879.0309.03
10min1114439-11443930.13924.6620.7830.1624.6820.79
279727-7972720.99721.01
363303-6330316.67216.68
494940-9494025.00425.02
5111761-11176129.43429.45
697656-9765625.71925.73
15min1178795-17879547.08842.8810.1247.1642.9310.14
2151656-15165639.94139.99
3136968-13696836.07236.11
4164923-16492343.43543.49
5180184-18018447.45447.52
6164307-16430743.27243.33
20min1212875-21287556.06353.686.3856.2153.816.40
2195153-19515351.39651.51
3181698-18169847.85247.95
4207360-20736054.61154.74
5216054-21605456.90157.05
6209838-20983855.26355.39
30min1241366-24136663.56762.444.1863.8162.654.20
2229656-22965660.48360.68
3220698-22069858.12458.30
4240117-24011763.23863.46
5246495-24649564.91865.16
6244098-24409864.28664.51
45min1261133-26113368.77368.862.8369.1269.182.86
2254627-25462767.05967.36
3250857-25085766.06666.34
4265196-26519669.84370.17
5268888-26888870.81571.16
6268196-26819670.63370.96
60min1273876-27387672.12972.562.2172.5973.002.23
2268888-26888870.81571.23
3268173-26817370.62771.01
4279903-27990373.71674.16
5280436-28043673.85674.32
6281914-28191474.24674.69
极限1280964-28096473.99574.811.7474.5875.371.76
2277843-27784373.17373.70
3280511-28051173.87674.38
4286618-28661875.48476.05
5288614-28861476.01076.60
6289871-28987176.34176.91
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500
标示量(mg)20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%
111.053787283780143776763781643785323782230.12
211.123792173782853787510.18
单位质量响应值RSD%判断
34228.3334060.340.35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%
5min136421-364219.5927.8619.899.597.8619.87
229111-291117.6677.67
319695-196955.1875.19
427627-276277.2767.28
534354-343549.0489.05
631841-318418.3868.39
10min1103095-10309527.15324.8812.9927.1724.9013.00
291230-9123024.02824.04
381692-8169221.51621.52
486401-8640122.75622.77
5114858-11485830.25130.27
689614-8961423.60223.62
15min1160011-16001142.14341.155.7642.2041.205.77
2148567-14856739.12939.18
3154781-15478140.76640.81
4152698-15269840.21740.27
5172456-17245645.42145.49
6148955-14895539.23139.28
20min1188240-18824049.57849.573.2849.7149.703.29
2180540-18054047.55047.67
3189119-18911949.81049.92
4187286-18728649.32749.44
5199130-19913052.44652.59
6185032-18503248.73348.85
30min1218130-21813057.45158.282.4057.6658.482.41
2213542-21354256.24256.44
3225570-22557059.41059.61
4220572-22057258.09458.29
5228494-22849460.18060.41
6221327-22132758.29358.49
45min1243784-24378464.20765.502.0064.5265.801.99
2241765-24176563.67563.97
3254875-25487567.12867.42
4249675-24967565.75966.05
5251529-25152966.24766.58
6250524-25052465.98266.28
60min1258077-25807767.97269.681.9868.3970.091.97
2258288-25828868.02768.42
3270876-27087671.34371.75
4266198-26619870.11170.52
5266063-26606370.07570.51
6267796-26779670.53170.94
极限1266855-26685570.28471.781.7170.8172.311.71
2266699-26669970.24370.75
3277885-27788573.18973.71
4274339-27433972.25572.78
5274154-27415472.20672.76
6275320-27532072.51373.04
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