非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.041906221908171906411901351906291905690.14
2 11.101891241890421890830.04
单位质量响应值RSD%判断
17261.6817034.500.94数据可信
供试品溶液-2025060821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%
5min14768-47682.5012.4512.412.502.4612.44
23813-38132.0002.00
35150-51502.7012.70
45204-52042.7292.73
54120-41202.1612.16
65026-50262.6362.64
10min110944-109445.7406.6116.485.746.6116.51
211244-112445.8975.90
315565-155658.1638.17
413475-134757.0677.07
510295-102955.3995.40
614045-140457.3667.37
15min114957-149577.8448.7614.607.868.7814.59
215087-150877.9127.93
320167-2016710.57610.59
417499-174999.1779.19
513923-139237.3027.31
618631-186319.7719.79
20min117823-178239.34710.2713.099.3710.3013.10
218367-183679.6329.66
323240-2324012.18812.22
420521-2052110.76210.79
516265-162658.5308.55
621313-2131311.17711.21
30min121962-2196211.51812.7110.7211.5612.7610.73
223289-2328912.21412.26
327752-2775214.55414.61
426016-2601613.64413.69
520965-2096510.99511.03
625433-2543313.33813.39
45min127543-2754314.44515.428.0114.5115.488.03
228998-2899815.20815.27
331459-3145916.49816.58
432270-3227016.92417.00
526052-2605213.66313.72
630036-3003615.75215.83
60min131520-3152016.53017.206.4116.6217.306.41
233227-3322717.42617.51
334571-3457118.13118.24
434997-3499718.35418.45
529317-2931715.37515.46
633190-3319017.40617.51
极限134746-3474618.22219.002.5818.3419.132.60
236493-3649319.13819.26
336752-3675219.27419.41
436720-3672019.25819.39
535473-3547318.60418.71
637221-3722119.52019.65
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.041896641895391893281893201895131894730.08
2 11.101890081887161888620.11
单位质量响应值RSD%判断
17162.4117014.590.62数据可信
供试品溶液-2025060921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%
5min13517-35171.8512.3140.081.852.3140.20
23258-32581.7151.71
37808-78084.1094.11
44671-46712.4582.46
53201-32011.6851.68
63882-38822.0432.04
10min110658-106585.6097.0926.615.617.0926.60
210992-109925.7855.79
319524-1952410.27510.28
415911-159118.3738.38
510785-107855.6765.68
612925-129256.8026.81
15min114563-145637.6649.6221.427.689.6421.41
216370-163708.6158.63
324379-2437912.83012.85
421216-2121611.16511.18
514633-146337.7017.71
618559-185599.7679.78
20min117858-178589.39811.2716.959.4211.3016.96
220690-2069010.88810.92
326696-2669614.04914.09
424439-2443912.86112.90
517470-174709.1949.22
621304-2130411.21111.24
30min122431-2243111.80513.6613.7411.8513.7113.76
226229-2622913.80313.85
330861-3086116.24116.31
428681-2868115.09415.15
521538-2153811.33511.37
625983-2598313.67413.72
45min126423-2642313.90515.9010.8913.9715.9810.90
232278-3227816.98717.05
333886-3388617.83317.93
432350-3235017.02417.11
526048-2604813.70813.77
630319-3031915.95616.03
60min130641-3064116.12517.507.2716.2117.607.31
235098-3509818.47118.57
335761-3576118.82018.95
434054-3405417.92118.03
529880-2988015.72515.81
634060-3406017.92418.02
极限136486-3648619.20119.055.0119.3119.185.04
237029-3702919.48719.61
337682-3768219.83019.99
436217-3621719.06019.20
532646-3264617.18017.29
637105-3710519.52719.66
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.041892701893631894031892641893341893270.04
2 11.101875431877181876300.07
单位质量响应值RSD%判断
17149.1816903.601.02数据可信
供试品溶液-2025061021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%
5min14531-45312.3932.2236.152.392.2236.09
26458-64583.4113.41
33257-32571.7201.72
42660-26601.4051.41
55429-54292.8682.87
62933-29331.5491.55
10min114241-142417.5227.6321.197.537.6321.18
218464-184649.7539.76
315989-159898.4458.45
49341-93414.9344.94
515324-153248.0948.10
613274-132747.0117.01
15min118738-187389.89710.3117.449.9110.3317.43
224086-2408612.72212.74
321580-2158011.39811.42
414303-143037.5557.57
520753-2075310.96210.98
617655-176559.3259.34
20min122118-2211811.68311.7913.9411.7211.8313.94
225938-2593813.70013.74
324393-2439312.88412.92
417179-171799.0749.10
523679-2367912.50712.54
620667-2066710.91610.95
30min127767-2776714.66614.1210.3314.7214.1710.34
229560-2956015.61315.68
328351-2835114.97515.03
421902-2190211.56911.61
527559-2755914.55714.61
625199-2519913.31013.36
45min130833-3083316.28616.017.9116.3616.087.95
232597-3259717.21817.31
331715-3171516.75216.83
426178-2617813.82713.88
531688-3168816.73716.82
628807-2880715.21615.29
60min133662-3366217.78017.406.4317.8817.506.46
234285-3428518.10918.23
334284-3428418.10918.22
429122-2912215.38215.46
534481-3448118.21318.32
631811-3181116.80216.90
极限136882-3688219.48118.615.3719.6118.745.40
235592-3559218.80018.95
336334-3633419.19119.33
431689-3168916.73816.84
536208-3620819.12519.26
634713-3471318.33518.46
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