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%
111.373870843866773868233868463867533868370.04
211.353883873882123883000.04
单位质量响应值RSD%判断
34022.6034211.450.40数据可信
供试品溶液-BXJUS91批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17195-71959.4839.6413.239.489.6413.22
26016-60167.9297.93
39031-903111.90211.90
47167-71679.4469.45
57264-72649.5749.57
67219-72199.5149.51
10min127301-2730135.98135.504.2836.0335.564.28
226102-2610234.40134.45
327619-2761936.40036.47
426921-2692135.48035.53
528475-2847537.52837.58
625210-2521033.22533.28
15min136722-3672248.39847.472.1248.6547.722.13
235432-3543246.69746.93
336183-3618347.68747.96
436209-3620947.72147.97
536736-3673648.41648.68
634806-3480645.87246.11
20min141833-4183355.13455.441.0155.6655.961.02
241965-4196555.30855.80
342785-4278556.38856.92
442290-4229055.73656.25
541982-4198255.33055.86
641552-4155254.76355.26
30min150868-5086867.04166.312.7367.8767.132.73
248509-4850963.93264.73
352361-5236169.00969.86
450586-5058666.67067.49
550466-5046666.51167.35
649067-4906764.66865.46
45min159444-5944478.34477.671.0979.5478.861.09
258921-5892177.65578.81
359435-5943578.33279.56
459433-5943378.32979.52
558408-5840876.97878.19
657935-5793576.35577.51
60min165601-6560186.45885.120.9488.0986.740.93
264600-6460085.13986.73
364658-6465885.21686.88
464568-6456885.09786.73
563715-6371583.97385.61
664365-6436584.82986.41
90min170015-7001592.27692.930.6594.3995.020.63
270919-7091993.46795.53
371016-7101693.59595.73
470146-7014692.44994.55
570139-7013992.43994.54
670839-7083993.36295.41
极限173879-7387997.36896.561.38100.0099.171.37
273155-7315596.41498.99
374946-7494698.775101.43
472927-7292796.11498.73
572410-7241095.43298.05
672274-7227495.25397.82
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%
111.371942091945191945351947681945971945260.11
211.351955571957231956400.06
单位质量响应值RSD%判断
17108.7117237.000.53数据可信
供试品溶液-BXK34K1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13818-38189.99716.8848.4810.0016.8848.47
24226-422611.06511.07
34006-400610.48910.49
411553-1155330.25030.25
56404-640416.76816.77
68673-867322.70922.71
10min119833-1983351.93048.0324.8551.9948.1224.88
212938-1293833.87633.94
315281-1528140.01140.07
425986-2598668.04168.21
516521-1652143.25843.35
619496-1949651.04751.17
15min124449-2444964.01660.0219.1264.3660.3819.17
217930-1793046.94747.20
319871-1987152.02952.31
430338-3033879.43679.98
521057-2105755.13555.47
623899-2389962.57662.99
20min127003-2700370.70366.9815.8971.4067.6815.97
221275-2127555.70556.22
322966-2296660.13360.70
432720-3272085.67386.66
523570-2357061.71562.35
625962-2596267.97868.74
30min131134-3113481.52077.6210.9082.6178.6811.04
226093-2609368.32169.14
327233-2723371.30672.21
434978-3497891.58593.05
528054-2805473.45574.44
630374-3037479.53080.66
45min134107-3410789.30485.987.5690.8587.487.72
228927-2892775.74176.94
331562-3156282.64183.94
436080-3608094.47096.44
532314-3231484.61086.00
634034-3403489.11390.69
60min136513-3651395.60491.814.1197.6593.794.27
232643-3264385.47187.09
334727-3472790.92892.69
435790-3579093.71196.21
534470-3447090.25592.12
636248-3624894.91096.98
90min136427-3642795.37995.460.8297.9597.940.82
236104-3610494.53396.63
336520-3652095.62297.89
436201-3620194.78797.80
536941-3694196.72599.09
636548-3654895.69698.29
极限136519-3651995.62095.041.2698.7298.051.07
236559-3655995.72498.34
336704-3670496.10498.90
436060-3606094.41897.96
536456-3645695.45598.35
635481-3548192.90296.03
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%
111.371948921950771952381951971949561950720.08
211.351946721947681947200.04
单位质量响应值RSD%判断
17156.7317155.950.01数据可信
供试品溶液-BXK0L71批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15621-562114.73213.1025.0414.7313.1025.03
23849-384910.08810.09
36816-681617.86417.86
43822-382210.01710.02
55785-578515.16215.16
64096-409610.73510.73
10min116018-1601841.98134.8615.0542.0634.9315.05
211832-1183231.01031.07
313579-1357935.58835.69
411128-1112829.16529.22
515275-1527540.03340.12
611964-1196431.35631.42
15min120117-2011752.72345.9013.5953.0446.1713.60
215542-1554240.73340.96
317679-1767946.33446.63
415098-1509839.56939.79
520613-2061354.02354.33
616038-1603842.03342.27
20min123434-2343461.41754.0913.2862.0254.6113.29
218505-1850548.49948.95
320312-2031253.23453.79
417786-1778646.61447.05
524518-2451864.25864.86
619273-1927350.51150.98
30min127617-2761772.38065.6111.5873.3366.4311.61
222681-2268159.44360.17
324669-2466964.65365.50
422391-2239158.68359.38
529492-2949277.29478.26
623356-2335661.21261.96
45min131894-3189483.58977.5310.1384.9478.7210.17
226905-2690570.51471.57
329484-2948477.27378.48
427082-2708270.97872.00
534353-3435390.03491.43
627770-2777072.78173.87
60min134902-3490291.47385.307.5893.2986.917.67
230349-3034979.54080.99
333117-3311786.79488.43
430314-3031479.44880.86
535898-3589894.08395.98
630691-3069180.43681.93
90min137694-3769498.79093.433.89101.1195.524.03
234330-3433089.97391.86
336020-3602094.40396.52
434091-3409189.34791.21
536582-3658295.87698.29
635174-3517492.18594.12
极限136753-3675396.32496.660.5899.2099.270.40
236819-3681996.49798.88
336966-3696696.88299.53
437037-3703797.06899.42
536566-3656695.83498.78
637147-3714797.35699.81
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