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%
1 11.173794473793263793713793513793803793750.02
2 11.233781523775623778570.12
单位质量响应值RSD%判断
33963.7433647.110.67数据可信
供试品溶液-1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%
5min14247-42475.6494.5015.685.654.5015.66
23289-32894.3754.37
33049-30494.0564.06
43639-36394.8404.84
53363-33634.4734.47
62696-26963.5863.59
10min122633-2263330.10422.3920.8730.1422.4220.86
216532-1653221.98922.01
314700-1470019.55319.58
419061-1906125.35325.38
512839-1283917.07717.10
615255-1525520.29120.31
15min133530-3353044.59937.2511.3144.8037.4011.34
228105-2810537.38337.53
326197-2619734.84534.98
428785-2878538.28738.46
527287-2728736.29536.41
624111-2411132.07032.20
20min140194-4019453.46346.8110.9253.9147.1710.92
237504-3750449.88550.24
331939-3193942.48242.81
435259-3525946.89847.28
536624-3662448.71449.04
629644-2964439.43039.74
30min150421-5042167.06659.349.0067.8159.969.02
244129-4412958.69659.33
341947-4194755.79456.35
445774-4577460.88561.53
546623-4662362.01462.61
638778-3877851.57952.11
45min160041-6004179.86173.536.4480.9874.476.49
254669-5466972.71673.67
352393-5239369.68970.56
456671-5667175.37976.36
557584-5758476.59377.53
650316-5031666.92667.74
60min167577-6757789.88581.766.5091.4483.116.55
262373-6237382.96384.32
358113-5811377.29778.55
461655-6165582.00883.41
562939-6293983.71685.08
656157-5615774.69575.88
90min171901-7190195.63692.203.2497.7094.003.33
269971-6997193.06994.89
367404-6740489.65591.34
468728-6872891.41693.27
571568-7156895.19397.02
666312-6631288.20289.81
极限175462-75462100.37395.943.76102.9698.263.82
274647-7464799.289101.63
370187-7018793.35795.54
470974-7097494.40396.76
573006-7300697.10699.46
668487-6848791.09593.19
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%
1 11.173778273776503778103782463783603779790.09
2 11.233766903760933763920.12
单位质量响应值RSD%判断
33838.7633516.650.68数据可信
供试品溶液-1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%
5min19426-942612.58513.7712.6912.5913.7712.69
212167-1216716.24516.24
39536-953612.73212.73
411568-1156815.44515.45
510322-1032213.78113.78
68846-884611.81111.81
10min125104-2510433.51833.737.3233.5933.817.31
227334-2733436.49536.59
327732-2773237.02737.10
424091-2409132.16532.25
523393-2339331.23331.31
623931-2393131.95232.02
15min133784-3378445.10744.656.2345.3644.926.22
235849-3584947.86448.16
335903-3590347.93648.21
431505-3150542.06442.33
531256-3125641.73241.98
632366-3236643.21443.46
20min140254-4025453.74552.046.9454.2552.556.93
241736-4173655.72456.28
342054-4205456.14956.69
436250-3625048.39948.90
536178-3617848.30348.79
637367-3736749.89150.37
30min149639-4963966.27663.235.6467.0864.035.64
249687-4968766.34067.21
349978-4997866.72867.58
444461-4446159.36260.13
544841-4484159.87060.62
645528-4552860.78761.55
45min157490-5749076.75874.224.0577.9375.384.05
258830-5883078.54779.78
355066-5506673.52274.75
453073-5307370.86171.96
555645-5564574.29575.38
653447-5344771.36072.46
60min162863-6286383.93281.553.4385.5383.113.44
262311-6231183.19584.87
362598-6259883.57885.21
457691-5769177.02778.52
561677-6167782.34883.84
659323-5932379.20680.70
90min168190-6819091.04490.102.1493.1192.122.17
268307-6830791.20193.34
368531-6853191.50093.60
464646-6464686.31388.23
567790-6779090.51092.46
667427-6742790.02691.96
极限172259-7225996.47795.302.2699.0597.822.20
269605-6960592.93495.58
372195-7219596.39299.00
469108-6910892.27094.67
573029-7302997.50599.96
672052-7205296.20198.64
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