非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.201925781925711925441926161926671925950.03
211.251935331924621929980.40
单位质量响应值RSD%判断
17195.9817155.380.17数据可信
供试品溶液-BXK0L71批-盐酸溶液(7.65→1000)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110767-1076728.18723.8150.7728.1923.8150.76
29947-994726.04026.04
39526-952624.93824.94
4-0.0000.00
512969-1296933.95133.95
611360-1136029.73929.74
10min117577-1757746.01543.5317.0046.1743.6617.08
218480-1848048.37948.52
315956-1595641.77141.91
411852-1185231.02731.03
520054-2005452.49952.69
615855-1585541.50741.67
15min121250-2125055.63052.5513.3156.0452.9213.40
222587-2258759.13059.54
319520-1952051.10151.47
415853-1585341.50141.67
522764-2276459.59460.07
618457-1845748.31848.71
20min124043-2404362.94259.6411.5363.6660.3011.60
225773-2577367.47168.21
322824-2282459.75160.41
418991-1899149.71650.12
524696-2469664.65165.46
620358-2035853.29553.96
30min128694-2869475.11868.2710.4776.1969.2710.53
229080-2908076.12877.25
324882-2488265.13866.12
423043-2304360.32461.00
527603-2760372.26273.43
623172-2317260.66261.62
45min132807-3280785.88578.928.8487.3780.308.85
233138-3313886.75288.29
328166-2816673.73675.08
429207-2920776.46177.48
531124-3112481.47983.05
626446-2644669.23370.53
60min135093-3509391.87085.267.9893.8487.087.94
235208-3520892.17194.19
329767-2976777.92779.68
433324-3332487.23988.68
532896-3289686.11888.14
629126-2912676.24977.93
90min137099-3709997.12192.975.3899.6095.265.40
236737-3673796.17398.71
333177-3317786.85489.04
436165-3616594.67696.60
536905-3690596.61399.12
632990-3299086.36488.47
极限137103-3710397.13297.840.81100.15100.640.63
237048-3704896.988100.06
337774-3777498.888101.56
437340-3734097.752100.20
537273-3727397.577100.62
637694-3769498.679101.26
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.201934521937271935091935171935711935550.06
211.251936741937991937360.05
单位质量响应值RSD%判断
17281.7017220.980.25数据可信
供试品溶液-BXK0L71批-pH1.2盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18787-878722.90326.8835.4722.9026.8835.47
25950-595015.50815.51
36586-658617.16617.17
414222-1422237.06837.07
512964-1296433.79033.79
613367-1336734.84034.84
10min117602-1760245.87845.3523.7646.0145.5023.79
211837-1183730.85230.94
312958-1295833.77433.87
421839-2183956.92157.13
520622-2062253.74953.94
619547-1954750.94851.14
15min121165-2116555.16553.9420.3855.5554.3420.43
215094-1509439.34139.60
316084-1608441.92242.20
425000-2500065.16065.68
524577-2457764.05864.54
622243-2224357.97458.45
20min123498-2349861.24660.1418.1061.9360.8418.16
217507-1750745.63146.11
318625-1862548.54449.06
426433-2643368.89569.78
527843-2784372.57073.41
624547-2454763.98064.78
30min126977-2697770.31367.9515.3171.3468.9915.41
220735-2073554.04454.77
321795-2179556.80757.59
428601-2860174.54675.81
530971-3097180.72381.97
627349-2734971.28372.44
45min131928-3192883.21878.3212.1084.6479.7312.23
225141-2514165.52866.56
326039-2603967.86868.97
431830-3183082.96284.64
534314-3431489.43791.13
631033-3103380.88582.44
60min134595-3459590.16984.419.6492.0586.259.79
228163-2816373.40474.80
328975-2897575.52177.00
433175-3317586.46888.61
535924-3592493.63395.82
633473-3347387.24589.24
90min137069-3706996.61792.554.8399.0094.865.07
233716-3371687.87889.68
333152-3315286.40888.31
436052-3605293.96696.59
537272-3727297.14699.86
635785-3578593.27195.75
极限137224-3722497.02197.741.9799.94100.571.88
236703-3670395.66397.95
338725-38725100.933103.31
437721-3772198.317101.46
536878-3687896.11999.37
637751-3775198.395101.40
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