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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.143844363844683847143846753843523845290.05
211.203838413839023838720.02
单位质量响应值RSD%判断
34517.8634274.290.51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%
5min18074-807410.56312.0112.1810.5612.0112.19
27997-799710.46310.46
39147-914711.96711.97
410091-1009113.20213.20
58928-892811.68111.68
610832-1083214.17214.17
10min121958-2195828.72830.0615.9728.7930.1315.95
220860-2086027.29127.35
320935-2093527.38927.46
422690-2269029.68529.76
521091-2109127.59327.66
630321-3032139.66939.75
15min130552-3055239.97140.7112.4440.1940.9412.45
228310-2831037.03837.25
330276-3027639.61039.83
431024-3102440.58940.83
527933-2793336.54536.76
638583-3858350.47850.78
20min136356-3635647.56547.7111.1248.0148.1711.14
233935-3393544.39744.81
336299-3629947.49047.93
436005-3600547.10647.57
532186-3218642.10942.53
644023-4402357.59658.18
30min144826-4482658.64657.4410.8959.3558.1710.90
240580-4058053.09153.75
345406-4540659.40560.11
442882-4288256.10356.83
537903-3790349.58950.24
651844-5184467.82868.73
45min154753-5475371.63468.338.9572.6669.378.97
248915-4891563.99664.95
353760-5376070.33471.37
449607-4960764.90165.94
546799-4679961.22762.16
659516-5951677.86579.14
60min160401-6040179.02375.458.6880.4576.878.71
253799-5379970.38671.70
358539-5853976.58778.01
454005-5400570.65572.05
553268-5326869.69170.96
665992-6599286.33888.05
极限174393-7439397.32998.031.4099.2099.871.38
276455-76455100.026101.73
373527-7352796.19698.04
474353-7435397.27699.07
575235-7523598.430100.09
675590-7559098.895101.08
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.143839883840113841823838893837633839670.05
211.203839143838463838800.02
单位质量响应值RSD%判断
34467.4134275.000.40数据可信
供试品溶液-24070901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%
5min113372-1337217.50720.1711.1317.5120.1711.11
216577-1657721.70321.70
317342-1734222.70522.70
416820-1682022.02222.02
513748-1374818.00018.00
614585-1458519.09519.10
10min122665-2266529.67434.189.6529.7734.299.66
228524-2852437.34537.47
327985-2798536.63936.77
427503-2750336.00836.13
523245-2324530.43330.53
626715-2671534.97635.08
15min129546-2954638.68344.1210.2238.9544.4210.21
237265-3726548.78949.12
337020-3702048.46848.80
434621-3462145.32745.65
529560-2956038.70138.97
634186-3418644.75845.06
20min134325-3432544.94050.5410.7745.4251.0910.75
242808-4280856.04656.65
344333-4433358.04358.64
438334-3833450.18950.76
534698-3469845.42845.91
637123-3712348.60349.15
30min141626-4162654.49962.019.2055.2362.849.20
251871-5187167.91268.82
352703-5270369.00169.92
447440-4744062.11162.96
543813-4381357.36258.10
646712-4671261.15761.98
45min151423-5142367.32574.086.8468.3575.256.88
260620-6062079.36680.65
361233-6123380.16981.47
456695-5669574.22875.43
553421-5342169.94171.00
656081-5608173.42474.58
60min158862-5886277.06582.335.1678.4783.925.23
266195-6619586.66688.39
366555-6655587.13788.89
463844-6384483.58785.20
559640-5964078.08379.53
662225-6222581.46883.03
极限175440-7544098.769101.531.81100.60103.571.78
277865-77865101.944104.15
376319-7631999.920102.15
478033-78033102.164104.24
579184-79184103.671105.55
678455-78455102.717104.74
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