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%
111.023826443825653833523837493831823830980.13
210.883810593814433812510.08
单位质量响应值RSD%判断
34763.8835041.450.57数据可信
供试品溶液-BXK0LE1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%
5min110852-1085213.9819.9125.3813.989.9125.39
25885-58857.5827.58
36684-66848.6118.61
48715-871511.22711.23
58183-818310.54210.54
65825-58257.5047.50
10min125664-2566433.06330.0112.1633.1430.0712.17
221462-2146227.64927.69
322053-2205328.41128.46
427961-2796136.02236.08
521409-2140927.58127.64
621229-2122927.34927.39
15min134068-3406843.88941.1211.3144.1541.3411.32
229782-2978238.36838.56
329005-2900537.36737.57
438220-3822049.23849.50
529221-2922137.64537.86
631215-3121540.21440.41
20min139668-3966851.10448.2410.2051.6148.6910.21
235992-3599246.36846.78
334106-3410643.93844.35
444107-4410756.82357.36
534423-3442344.34744.77
636374-3637446.86047.28
30min148991-4899163.11558.497.8963.9059.217.93
244546-4454657.38858.05
341944-4194454.03654.69
450687-5068765.29966.15
542745-4274555.06855.74
643517-4351756.06256.74
45min155820-5582071.91269.574.7873.0570.624.86
252402-5240267.50968.49
352640-5264067.81668.77
458461-5846175.31576.53
552073-5207367.08568.06
652635-5263567.80968.80
60min161122-6112278.74376.603.9180.2878.033.98
259489-5948976.63978.00
357345-5734573.87775.21
462870-6287080.99582.63
556626-5662672.95174.30
659293-5929376.38677.75
极限165664-6566484.59482.782.8986.5784.642.94
263703-6370382.06883.85
364412-6441282.98184.73
465909-6590984.91086.99
560851-6085178.39480.14
665009-6500983.75085.54
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%
111.023801583791473798283793073798423796560.11
210.883778783764893771840.27
单位质量响应值RSD%判断
34451.5434667.650.45数据可信
供试品溶液-BXK0LE1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%
5min17069-70699.1978.4724.109.208.4724.09
25632-56327.3287.33
37367-73679.5859.58
45589-55897.2727.27
58891-889111.56811.57
64517-45175.8775.88
10min126588-2658834.59328.5216.7934.6428.5616.79
222106-2210628.76128.80
320973-2097327.28727.34
421477-2147727.94327.98
524594-2459431.99932.06
615787-1578720.54020.57
15min137479-3747948.76338.6616.3549.0138.8716.35
230394-3039439.54539.75
328834-2883437.51537.72
426408-2640834.35934.55
531857-3185741.44841.69
623322-2332230.34430.49
20min144032-4403257.28945.8415.1357.8046.2615.13
236287-3628747.21247.63
332917-3291742.82743.24
431675-3167541.21141.60
537582-3758248.89749.37
628913-2891337.61837.93
30min153812-5381270.01356.7812.9370.8557.4612.96
244590-4459058.01558.70
342346-4234655.09555.75
439755-3975551.72452.34
543868-4386857.07557.82
637479-3747948.76349.29
45min162276-6227681.02567.6410.3782.2568.6310.42
252407-5240768.18569.19
349164-4916463.96664.92
448356-4835662.91563.82
552004-5200467.66168.72
647732-4773262.10362.90
60min167341-6734187.61576.078.8389.2977.438.91
259986-5998678.04679.43
354894-5489471.42172.73
456077-5607772.96074.21
559700-5970077.67479.11
652793-5279368.68769.83
极限170213-7021391.35281.127.1093.5182.917.20
261357-6135779.83081.65
358843-5884376.55978.27
459700-5970077.67479.33
564769-6476984.26986.14
659193-5919377.01478.54
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%
111.023793413803793790543792623787293793530.17
210.883785913807563796740.41
单位质量响应值RSD%判断
34424.0534896.510.97数据可信
供试品溶液-BXJUS91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%
5min16650-66508.6278.6022.338.638.6022.34
25144-51446.6746.67
36064-60647.8677.87
45689-56897.3817.38
59366-936612.15112.15
66842-68428.8768.88
10min125644-2564433.26930.257.3733.3230.307.36
222369-2236929.02029.06
323325-2332530.26030.30
424427-2442731.69031.73
523482-2348230.46430.53
620640-2064026.77726.83
15min134598-3459844.88540.236.7945.1240.456.77
230321-3032139.33739.53
330327-3032739.34439.56
432274-3227441.87042.09
529850-2985038.72638.96
628695-2869537.22737.43
20min140247-4024752.21447.476.0852.7047.916.07
235978-3597846.67647.09
336425-3642547.25647.69
437663-3766348.86249.31
535610-3561046.19846.65
633625-3362543.62344.03
30min148924-4892463.47158.105.1764.2458.805.17
244657-4465757.93558.61
343970-4397057.04457.74
445603-4560359.16259.88
542504-4250455.14255.85
643026-4302655.81956.47
45min156380-5638073.14469.623.6574.2770.653.66
254630-5463070.87471.87
353726-5372669.70170.71
454451-5445170.64171.69
551449-5144966.74767.76
651365-5136566.63867.60
60min163094-6309481.85477.922.9183.3979.332.93
260458-6045878.43479.83
359219-5921976.82778.22
460422-6042278.38879.83
558020-5802075.27276.66
659134-5913476.71778.04
极限168642-6864289.05284.932.9991.0486.773.00
262938-6293881.65283.48
365750-6575085.30087.12
465467-6546784.93386.81
566013-6601385.64187.45
663958-6395882.97584.73
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%
111.023771613778653789893780463771173778360.21
210.883796793794563795680.05
单位质量响应值RSD%判断
34286.3934886.761.23数据可信
供试品溶液-BXJUS91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%
5min16893-68938.9628.4016.618.968.4016.63
25810-58107.5547.55
37721-772110.03810.04
44747-47476.1726.17
56349-63498.2558.25
67239-72399.4129.41
10min127077-2707735.20427.4517.6935.2527.4917.67
219192-1919224.95224.99
320688-2068826.89726.95
416755-1675521.78421.82
519135-1913524.87824.92
623816-2381630.96431.02
15min135100-3510045.63536.8814.8845.8837.0814.89
226826-2682634.87835.06
327099-2709935.23235.44
423933-2393331.11631.27
525467-2546733.11133.29
631775-3177541.31241.54
20min139634-3963451.53042.9012.5752.0343.3112.59
231585-3158541.06541.44
332241-3224141.91842.32
428091-2809136.52236.85
530474-3047439.62039.99
635972-3597246.76947.22
30min146974-4697461.07353.6310.0461.8654.2710.09
240513-4051352.67353.28
339247-3924751.02751.66
436128-3612846.97147.50
539169-3916950.92551.51
645472-4547259.12059.83
45min156799-5679973.84764.909.7974.9765.849.83
250097-5009765.13366.03
347520-4752061.78362.70
444555-4455557.92858.72
545945-4594559.73560.61
654571-5457170.95071.99
60min162890-6289081.76672.908.0683.3074.208.12
256504-5650473.46374.72
354143-5414370.39371.65
450460-5046065.60566.72
553054-5305468.97870.18
659383-5938377.20678.64
极限166714-6671486.73878.527.8488.7380.227.90
261270-6127079.66081.32
358157-5815775.61277.26
454308-5430870.60872.09
557181-5718174.34375.93
664722-6472284.14886.01
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