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%
111.193804023803793802273803533805883803900.04
211.173797973800223799100.05
单位质量响应值RSD%判断
33993.7434011.640.04数据可信
供试品溶液-250214701-2裸片批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14216-42165.5755.0215.515.585.0215.50
24048-40485.3535.35
33850-38505.0915.09
44422-44225.8485.85
53401-34014.4974.50
62827-28273.7383.74
10min110420-1042013.77916.7823.1213.8116.8023.11
215543-1554320.55420.58
313208-1320817.46617.49
416068-1606821.24821.28
512447-1244716.45916.48
68449-844911.17311.19
15min124828-2482832.83236.3717.6132.9436.4917.62
233273-3327343.99944.14
326184-2618434.62534.75
433399-3339944.16644.32
525981-2598134.35634.47
621340-2134028.21928.30
20min134579-3457945.72649.3612.2746.0249.6812.30
243988-4398858.16858.56
334931-3493146.19246.51
442110-4211055.68556.08
535631-3563147.11747.42
632710-3271043.25543.49
30min148318-4831863.89465.428.3664.4466.028.41
256121-5612174.21374.92
347217-4721762.43863.01
452966-5296670.04070.75
546208-4620861.10461.67
646018-4601860.85361.33
45min158780-5878077.72978.205.6578.6379.165.70
262520-6252082.67483.80
356881-5688175.21876.14
463350-6335083.77284.87
554545-5454572.12873.04
658730-5873077.66378.48
60min164838-6483885.74084.944.3687.0786.344.41
266325-6632587.70689.29
362553-6255382.71884.06
468014-6801489.93991.50
560146-6014679.53580.84
663540-6354084.02385.27
极限177946-77946103.073103.021.41104.88104.891.37
276309-76309100.908102.98
379477-79477105.098106.90
478720-78720104.097106.16
577547-77547102.546104.30
677458-77458102.428104.14
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%
111.193797703797813798803797163792753796840.07
211.173802893804433803660.03
单位质量响应值RSD%判断
33930.6534052.460.26数据可信
供试品溶液-250214701-裸片批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14427-44275.8565.979.635.865.989.63
25228-52286.9166.92
34309-43095.7005.70
44296-42965.6835.68
54019-40195.3165.32
64816-48166.3716.37
10min116848-1684822.28722.379.0022.3222.409.00
219331-1933125.57125.61
317917-1791723.70123.73
416175-1617521.39621.43
515015-1501519.86219.89
616168-1616821.38721.42
15min128136-2813637.21837.833.8737.3737.983.88
230332-3033240.12340.30
329010-2901038.37538.54
428712-2871237.98038.13
526962-2696235.66535.81
628425-2842537.60137.75
20min135388-3538846.81147.412.5047.1747.782.53
237136-3713649.12449.53
336059-3605947.69948.08
436270-3627047.97848.34
534467-3446745.59345.93
635738-3573847.27447.64
30min144821-4482159.28960.262.4259.9160.892.42
246063-4606360.93261.61
346524-4652461.54262.18
446964-4696462.12462.75
544674-4467459.09559.69
644299-4429958.59959.22
45min154646-5464672.28673.202.3173.2474.172.29
255191-5519173.00774.02
356395-5639574.59975.58
457165-5716575.61876.59
555070-5507072.84773.77
653571-5357170.86471.82
60min161604-6160481.49082.582.6082.8483.962.56
262746-6274683.00184.42
362103-6210382.15083.55
464010-6401084.67386.07
564232-6423284.96686.29
659889-5988979.22180.57
极限166035-6603587.35192.204.8589.1694.034.79
274971-7497199.172101.05
369945-6994592.52394.38
471211-7121194.19896.06
570018-7001892.62094.42
666032-6603287.34789.13
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