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 11.041917441916651915591914451915381915900.07
2 11.101903941904711904320.03
单位质量响应值RSD%判断
17354.1717156.040.82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%
5min14259-42592.2202.3014.112.222.3014.08
24369-43692.2772.28
33412-34121.7781.78
44287-42872.2342.23
54925-49252.5672.57
65206-52062.7132.71
10min112051-120516.2816.5718.306.286.5818.32
212355-123556.4396.44
311276-112765.8775.88
411397-113975.9405.94
517238-172388.9848.99
611355-113555.9185.92
15min116034-160348.3578.7816.608.378.8016.61
216410-164108.5538.57
315372-153728.0128.02
415480-154808.0688.08
522487-2248711.72011.74
615308-153087.9787.99
20min119837-1983710.33910.3913.9110.3710.4213.91
219560-1956010.19410.22
317817-178179.2869.31
418388-183889.5849.61
525371-2537113.22313.26
618592-185929.6909.72
30min124222-2422212.62412.9210.9912.6712.9711.00
224823-2482312.93712.98
322827-2282711.89711.94
423079-2307912.02812.07
530144-3014415.71115.77
623642-2364212.32212.37
45min129254-2925415.24715.486.5315.3115.556.57
230733-3073316.01816.08
327780-2778014.47914.54
428244-2824414.72014.78
533081-3308117.24117.33
629159-2915915.19715.26
60min134479-3447917.97017.473.6418.0617.563.66
234087-3408717.76617.86
331804-3180416.57616.66
432176-3217616.77016.86
534638-3463818.05318.17
633933-3393317.68517.78
极限136907-3690719.23519.063.3519.3619.193.35
237818-3781819.71019.83
334247-3424717.84917.96
436676-3667619.11519.23
536607-3660719.07919.22
637225-3722519.40119.52
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 11.041902681908281908621905411902461905490.16
2 11.101901221901631901420.02
单位质量响应值RSD%判断
17259.8717129.910.54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%
5min13758-37581.9651.9921.141.971.9921.12
24684-46842.4502.45
34214-42142.2042.20
42388-23881.2491.25
54276-42762.2362.24
63542-35421.8521.85
10min115050-150507.8716.8913.547.876.8913.52
213835-138357.2367.24
311657-116576.0976.10
412881-128816.7376.74
514954-149547.8217.82
610650-106505.5705.57
15min119890-1989010.4029.4312.2910.429.4512.29
218313-183139.5789.59
315573-155738.1458.16
419806-1980610.35910.37
519640-1964010.27210.29
614994-149947.8427.85
20min122587-2258711.81311.0411.7611.8511.0711.75
221321-2132111.15111.18
318594-185949.7259.75
423896-2389612.49812.53
522588-2258811.81411.85
617610-176109.2109.24
30min126449-2644913.83313.469.9913.8913.509.99
225916-2591613.55413.60
323248-2324812.15912.20
429351-2935115.35115.40
527067-2706714.15614.21
622358-2235811.69311.73
45min129584-2958415.47215.557.9015.5515.627.91
231082-3108216.25616.33
327549-2754914.40814.47
433152-3315217.33817.42
530281-3028115.83715.91
626740-2674013.98514.05
60min131886-3188616.67617.225.1916.7817.315.21
234215-3421517.89417.99
332902-3290217.20817.30
434841-3484118.22218.33
533528-3352817.53517.64
630135-3013515.76115.84
极限136531-3653119.10619.171.5819.2419.301.60
237269-3726919.49219.62
336540-3654019.11019.23
436679-3667919.18319.32
537210-3721019.46119.59
635678-3567818.66018.77
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 11.041907541905021907831905111906301906360.07
2 11.101896491894741895620.07
单位质量响应值RSD%判断
17267.7517077.660.79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%
5min13697-36971.9361.8019.911.941.8019.95
24406-44062.3072.31
32799-27991.4661.47
42998-29981.5701.57
53994-39942.0922.09
62776-27761.4541.45
10min113212-132126.9196.118.196.926.118.18
211508-115086.0276.03
311146-111465.8375.84
410809-108095.6615.66
512430-124306.5096.51
610919-109195.7185.72
15min117499-174999.1648.236.689.188.246.70
215372-153728.0508.06
315288-152888.0068.02
414611-146117.6527.66
516365-163658.5708.58
615106-151067.9117.92
20min120074-2007410.51210.113.3310.5410.133.36
219507-1950710.21610.24
318937-189379.9179.94
418482-184829.6799.70
519951-1995110.44810.48
618858-188589.8769.90
30min124698-2469812.93412.651.4712.9812.701.49
224171-2417112.65812.70
323850-2385012.49012.53
424377-2437712.76612.81
524144-2414412.64412.69
623723-2372312.42312.46
45min129625-2962515.51415.482.6415.5815.542.61
229575-2957515.48815.55
328361-2836114.85214.92
430804-3080416.13216.19
529381-2938115.38615.45
629608-2960815.50515.57
60min133281-3328117.42917.272.0017.5217.361.98
233043-3304317.30417.40
332122-3212216.82216.91
434054-3405417.83417.92
532718-3271817.13417.23
632658-3265817.10217.19
极限136205-3620518.96018.931.2819.0819.041.29
236606-3660619.17019.29
335267-3526718.46918.58
436413-3641319.06919.19
536184-3618418.94919.07
636179-3617918.94619.06
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