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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.321931531933121933911933791932121932890.06
211.321951011954741952880.14
单位质量响应值RSD%判断
17075.0017251.590.73数据可信
供试品溶液-BXK34K1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19232-923224.20623.1021.2324.2123.1021.24
29556-955625.05525.06
37617-761719.97119.97
411658-1165830.56730.57
56127-612716.06516.06
68672-867222.73722.74
10min117714-1771446.44550.1816.3546.5850.3016.36
221232-2123255.66955.81
315905-1590541.70241.81
424095-2409563.17663.35
516420-1642043.05243.14
619454-1945451.00751.13
15min120671-2067154.19860.0914.0654.5960.4914.08
225706-2570667.40067.85
319776-1977651.85252.19
427421-2742171.89672.42
520082-2008252.65452.98
623845-2384562.52062.93
20min122837-2283759.87766.0211.8960.5766.7611.93
227986-2798673.37874.20
322340-2234058.57459.20
428949-2894975.90376.82
522458-2245858.88459.50
626500-2650069.48270.24
30min126366-2636669.13074.649.8170.1675.759.86
230628-3062880.30581.54
325683-2568367.33968.30
431444-3144482.44483.79
525773-2577367.57568.52
630911-3091181.04782.19
45min128532-2853274.80981.067.6576.2282.587.73
232243-3224384.53986.22
329050-2905076.16777.50
433142-3314286.89688.70
528830-2883075.59176.91
633694-3369488.34489.94
60min130673-3067380.42385.805.9882.2587.776.07
233860-3386088.77990.93
331139-3113981.64583.40
434053-3405389.28591.57
531226-3122681.87383.62
635390-3539092.79194.87
极限137207-3720797.55595.701.4499.8398.141.30
236086-3608694.61597.26
336983-3698396.96799.17
436029-3602994.46697.24
536023-3602394.45096.65
636661-3666196.12398.72
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.321934621935521935171932901932651934170.07
211.321945501943641944570.07
单位质量响应值RSD%判断
17086.3117178.180.38数据可信
供试品溶液-BXK3152批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18626-862622.65717.8819.0922.6617.8819.10
26746-674617.71917.72
36780-678017.80917.81
45289-528913.89213.89
57890-789020.72420.72
65521-552114.50214.50
10min119210-1921050.45844.5515.5050.5844.6515.49
216264-1626442.72042.82
319841-1984152.11552.21
412416-1241632.61232.69
516914-1691444.42744.54
617121-1712144.97145.05
15min124606-2460664.63156.3514.5765.0456.7014.57
219481-1948151.17051.51
324454-2445464.23264.62
416616-1661643.64443.90
520690-2069054.34554.71
622882-2288260.10360.43
20min127120-2712071.23562.9712.5172.0063.6312.53
221877-2187757.46358.08
326428-2642869.41770.16
419364-1936450.86251.36
523350-2335061.33262.00
625700-2570067.50568.17
30min131260-3126082.10971.8511.0583.2772.8611.06
224803-2480365.14966.09
328820-2882075.70076.83
423904-2390462.78763.57
525480-2548066.92767.93
629861-2986178.43479.47
45min134414-3441490.39380.5110.0792.0181.9210.09
227712-2771272.79074.09
332662-3266285.79187.34
427550-2755072.36473.50
528427-2842774.66876.04
633138-3313887.04288.52
60min136138-3613894.92285.938.6297.0487.798.66
229791-2979178.25079.96
334121-3412189.62491.65
430417-3041779.89581.43
530445-3044579.96881.76
635375-3537592.91894.88
极限137033-3703397.27396.911.6299.9299.241.45
236498-3649895.86798.01
336215-3621595.12497.65
437791-3779199.264101.24
537322-3732298.032100.27
636514-3651495.90998.38
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.323844503842763842853842603842823843110.03
211.323863833864123863980.01
单位质量响应值RSD%判断
33949.7334134.100.39数据可信
供试品溶液-BXK0LE1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113967-1396718.46314.3722.6918.4614.3722.69
210035-1003513.26513.27
37334-73349.6959.69
411639-1163915.38615.39
512988-1298817.16917.17
69274-927412.25912.26
10min127173-2717335.92033.6818.3636.0233.7618.36
223320-2332030.82730.90
321416-2141628.31028.36
425869-2586934.19634.28
533730-3373044.58844.68
621350-2135028.22328.29
15min134918-3491846.15845.4815.5546.4645.7515.56
232333-3233342.74142.99
330660-3066040.53040.74
434067-3406745.03345.31
544592-4459258.94759.29
629869-2986939.48439.71
20min140334-4033453.31853.7614.1353.8854.2814.15
238643-3864351.08351.56
336544-3654448.30848.74
440570-4057053.63054.16
551763-5176368.42669.10
636134-3613447.76648.21
30min148394-4839463.97263.5111.4364.8364.3311.48
245463-4546360.09860.86
344671-4467159.05159.76
447167-4716762.35163.17
558727-5872777.63278.68
643861-4386157.98058.69
45min155561-5556173.44773.949.1574.6675.119.23
253198-5319870.32371.42
352896-5289669.92470.96
456407-5640774.56575.73
565763-6576386.93388.41
651783-5178368.45269.48
60min161440-6144081.21881.766.5782.8483.346.69
259979-5997979.28780.78
359126-5912678.15979.58
462380-6238082.46184.04
569617-6961792.02793.99
658569-5856977.42378.83
极限172260-7226095.52195.981.2797.5998.021.42
272098-7209895.30797.24
371227-7122794.15696.01
473358-7335896.97399.01
573727-7372797.46099.94
672991-7299196.48798.33
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.323825673832023822893824853827713826630.10
211.323901953908103905020.12
单位质量响应值RSD%判断
33804.1534496.641.44数据可信
供试品溶液-BXK0LE1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17960-796010.49012.4716.7610.4912.4716.74
28799-879911.59611.60
39483-948312.49712.50
412046-1204615.87515.87
58000-800010.54310.54
610488-1048813.82113.82
10min122792-2279230.03630.747.5630.0930.817.54
220770-2077027.37127.44
322821-2282130.07430.14
423780-2378031.33831.43
526181-2618134.50234.56
623606-2360631.10931.19
15min133381-3338143.99142.406.9644.2242.646.93
228603-2860337.69437.91
331977-3197742.14042.38
431343-3134341.30541.57
535338-3533846.57046.82
632414-3241442.71642.97
20min140563-4056353.45549.907.0953.9250.387.07
233598-3359844.27744.70
338008-3800850.08850.56
436087-3608747.55748.05
540521-4052153.40053.91
638429-3842950.64351.13
30min149590-4959065.35159.917.8066.1260.667.77
239993-3999352.70453.38
345358-4535859.77460.52
443305-4330557.06957.82
548795-4879564.30465.11
645737-4573760.27461.04
45min156628-5662874.62670.487.0375.7671.577.01
247598-4759862.72663.69
354461-5446171.77172.85
450413-5041366.43667.51
557316-5731675.53376.70
654474-5447471.78872.89
60min163062-6306283.10577.966.1884.6579.446.17
253685-5368570.74872.06
359949-5994979.00380.48
456286-5628674.17675.62
562701-6270182.63084.21
659274-5927478.11379.62
极限172900-7290096.07095.011.6298.0896.931.66
270575-7057593.00694.71
373832-7383297.29899.22
472068-7206894.97496.83
572026-7202694.91896.96
671195-7119593.82395.76
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