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 11.133664603666793657743666743667163664610.11
2 11.053645303645613645460.01
单位质量响应值RSD%判断
32925.5232990.590.14数据可信
供试品溶液-2025082921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%
5min111884-1188416.21315.0720.7616.2115.0720.77
28518-851811.62111.62
313611-1361118.56918.57
410329-1032914.09214.09
513426-1342618.31718.32
68511-851111.61111.61
10min122274-2227430.38829.1113.9230.4829.1913.94
219098-1909826.05526.12
325286-2528634.49734.60
420782-2078228.35228.43
523451-2345131.99432.10
617118-1711823.35423.42
15min127479-2747937.48937.3211.5137.7537.5611.53
226280-2628035.85336.06
330899-3089942.15542.45
426530-2653036.19436.43
530566-3056641.70141.98
622378-2237830.53030.72
20min133338-3333845.48245.288.8445.9545.748.89
232772-3277244.71045.12
336655-3665550.00850.54
432650-3265044.54444.98
535544-3554448.49249.00
628190-2819038.45938.82
30min140696-4069655.52156.258.0056.2456.958.04
241606-4160656.76257.42
345195-4519561.65962.47
440841-4084155.71956.40
543519-4351959.37260.15
635506-3550648.44049.02
45min147874-4787465.31467.986.8266.3468.996.85
251644-5164470.45771.43
353886-5388673.51674.67
449661-4966167.75268.75
551609-5160970.40971.52
644276-4427660.40561.25
60min154280-5428074.05376.225.7275.4477.615.75
258772-5877280.18281.55
359245-5924580.82782.38
455948-5594876.32977.70
556395-5639576.93978.44
650554-5055468.97070.15
极限163551-6355186.70189.177.0588.5090.997.01
269153-6915394.34496.15
368822-6882293.89395.90
469663-6966395.04096.83
562800-6280085.67787.61
658189-5818979.38680.95
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 11.133648083653063658723655803649593653050.12
2 11.053646093641373643730.10
单位质量响应值RSD%判断
32821.6532974.930.33数据可信
供试品溶液-2025083021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%
5min114368-1436819.63818.279.8519.6418.279.84
212364-1236416.89916.90
311414-1141415.60015.60
413162-1316217.98917.99
513973-1397319.09819.10
614922-1492220.39520.39
10min124150-2415033.00732.376.4633.1232.476.46
222464-2246430.70330.80
321204-2120428.98129.07
424336-2433633.26233.36
524747-2474733.82333.93
625188-2518834.42634.54
15min130626-3062641.85942.525.3942.1542.805.41
230489-3048941.67141.94
328364-2836438.76739.01
432281-3228144.12144.41
531750-3175043.39543.69
633137-3313745.29145.60
20min135609-3560948.66950.094.8749.1950.614.88
235749-3574948.86049.36
334212-3421246.76047.22
437501-3750151.25551.78
537660-3766051.47252.01
639158-3915853.52054.08
30min143578-4357859.56160.964.4360.3661.764.41
245190-4519061.76462.53
343321-4332159.21059.93
442039-4203957.45758.27
547351-4735164.71865.54
646130-4613063.04963.90
45min153255-5325572.78775.332.2173.9176.462.23
255374-5537475.68376.79
354078-5407873.91274.96
455980-5598076.51277.65
555532-5553275.89977.08
656478-5647877.19278.40
60min157826-5782679.03583.693.1580.5785.253.09
261519-6151984.08285.61
363569-6356986.88488.35
460590-6059082.81284.37
561899-6189984.60186.20
662005-6200584.74686.38
极限171940-7194098.32597.834.09100.2999.843.97
273992-73992101.130103.13
374098-74098101.275103.22
469661-6966195.21097.23
573122-7312299.941102.01
666640-6664091.08193.18
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 11.133649413651113639143647513644973646430.13
2 11.053627183659303643240.63
单位质量响应值RSD%判断
32762.1732970.500.45数据可信
供试品溶液-2025083121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%
5min113285-1328518.17515.1517.3118.1815.1517.32
29330-933012.76412.76
310501-1050114.36614.37
411398-1139815.59415.59
513204-1320418.06418.06
68734-873411.94911.95
10min122624-2262430.95227.8912.7531.0527.9712.75
218623-1862325.47825.55
318741-1874125.64025.72
420796-2079628.45128.54
524108-2410832.98233.08
617403-1740323.80923.88
15min129226-2922639.98436.8710.1140.2637.1210.15
225437-2543734.80035.01
324937-2493734.11634.34
428194-2819438.57238.82
530431-3043141.63341.92
623495-2349532.14432.34
20min134545-3454547.26144.755.8347.7645.195.88
230965-3096542.36342.77
330241-3024141.37341.78
433038-3303845.19945.66
535046-3504647.94648.46
632409-3240944.33944.72
30min142511-4251158.15954.786.6958.9255.476.72
239861-3986154.53455.17
338094-3809452.11652.76
441701-4170157.05157.76
542282-4228257.84658.63
635780-3578048.95149.57
45min151978-5197871.11167.525.2772.1968.515.29
251121-5112169.93970.88
347311-4731164.72665.66
450163-5016368.62869.66
550398-5039868.95070.05
645131-4513161.74462.64
60min158691-5869180.29576.475.9481.7777.845.93
258775-5877580.41081.74
353766-5376673.55774.85
456873-5687377.80879.22
557015-5701578.00279.49
650231-5023168.72169.96
极限166591-6659191.10386.324.2493.0388.124.27
264720-6472088.54390.32
361878-6187884.65586.35
463268-6326886.55788.40
563397-6339786.73388.65
658718-5871880.33281.95
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