托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品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10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.459822798350985749828898444983770.14
2 16.539835398441983970.07
单位质量响应值RSD%判断
5980.365952.630.33数据可信
供试品溶液-2批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18746-87468.7959.027.408.809.027.42
28731-87318.7808.78
38386-83868.4338.43
48543-85438.5918.59
59206-92069.2589.26
610200-1020010.25710.26
10min123961-2396124.09623.371.8924.1423.421.89
223227-2322723.35823.41
322688-2268822.81622.86
422976-2297623.10523.15
523469-2346923.60123.65
623127-2312723.25723.31
15min134344-3434434.53734.641.1034.7234.821.09
234145-3414534.33734.52
334065-3406534.25634.43
434970-3497035.16735.34
534281-3428134.47434.66
634843-3484335.03935.23
20min143894-4389444.14142.412.6344.5242.792.61
242309-4230942.54742.92
341522-4152241.75542.12
442744-4274442.98443.36
540636-4063640.86441.24
641956-4195642.19242.57
30min153230-5323053.52951.962.7154.1552.572.69
251037-5103751.32451.93
350904-5090451.19051.79
453319-5331953.61954.23
549766-4976650.04650.65
651781-5178152.07252.69
45min159167-5916759.50060.911.4860.4261.811.44
260678-6067861.01961.91
360449-6044960.78961.67
461501-6150161.84762.75
561521-6152161.86762.75
660098-6009860.43661.34
60min170696-7069671.09368.192.3772.3469.432.34
267272-6727267.65068.88
367853-6785368.23469.45
468068-6806868.45169.70
565883-6588366.25367.48
667103-6710367.48068.72
90min175561-7556175.98674.061.6577.6375.671.63
274016-7401674.43276.04
372475-7247572.88274.48
474274-7427474.69176.32
573086-7308673.49775.09
672444-7244472.85174.47
120min178171-7817178.61078.131.1180.6880.161.09
277623-7762378.05980.08
376516-7651676.94678.95
478450-7845078.89180.94
578565-7856579.00781.01
676844-7684477.27679.30
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min183168-8316883.63582.971.1586.1485.431.14
281133-8113381.58984.04
382846-8284683.31285.74
483768-8376884.23986.72
581932-8193282.39284.83
682190-8219082.65285.10
240min187557-8755788.04986.440.9591.0289.360.94
285958-8595886.44189.35
385794-8579486.27689.17
485373-8537385.85388.81
585517-8551785.99888.89
685560-8556086.04188.95
极限188010-8801088.50588.440.6491.9691.840.61
288564-8856489.06292.45
387728-8772888.22191.59
487291-8729187.78291.21
588608-8860889.10692.48
687444-8744487.93591.32
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品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10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.454975649609496864946949556496150.23
2 16.535025250491503720.34
单位质量响应值RSD%判断
3016.113047.310.73数据可信
供试品溶液-2批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14412-44128.7328.5510.188.738.5510.14
23646-36467.2167.22
34391-43918.6908.69
43964-39647.8457.85
54792-47929.4849.48
64704-47049.3109.31
10min112673-1267325.08224.224.6325.1324.264.64
211183-1118322.13322.17
312101-1210123.95024.00
412627-1262724.99125.03
512232-1223224.20924.26
612599-1259924.93524.99
15min118628-1862836.86737.535.3137.0637.725.31
217180-1718034.00234.16
318872-1887237.35037.53
419982-1998239.54739.73
519597-1959738.78538.97
619532-1953238.65638.85
20min123222-2322245.95947.333.4146.3547.723.40
223280-2328046.07446.43
323065-2306545.64946.04
424904-2490449.28849.69
524432-2443248.35448.76
624591-2459148.66949.07
30min129227-2922757.84458.153.4758.4958.803.47
228743-2874356.88657.49
327764-2776454.94955.59
430508-3050860.37961.06
530194-3019459.75860.43
629849-2984959.07559.75
45min133992-3399267.27568.403.7368.2469.383.73
233093-3309365.49566.42
333180-3318065.66866.62
435745-3574570.74471.76
535558-3555870.37471.38
635796-3579670.84571.85
60min139186-3918677.55477.111.8078.9078.471.81
237702-3770274.61775.91
339123-3912377.43078.74
439841-3984178.85180.26
538994-3899477.17478.57
638918-3891877.02478.42
90min143953-4395386.98984.932.1888.7686.722.17
241925-4192582.97584.68
342047-4204783.21784.96
443829-4382986.74388.59
542280-4228083.67885.50
643453-4345385.99987.82
120min145055-4505589.17088.231.4691.4390.481.49
243533-4353386.15888.32
344094-4409487.26889.47
445179-4517989.41591.74
544593-4459388.25690.54
645021-4502189.10391.41
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min147564-4756494.13692.052.6596.8994.802.62
245774-4577490.59393.23
345127-4512789.31292.00
448417-4841795.82498.64
546246-4624691.52794.31
645943-4594390.92793.73
240min146449-4644991.92992.861.4995.2096.121.48
246158-4615891.35394.50
347321-4732193.65596.84
447835-4783594.67298.03
547446-4744693.90297.19
646316-4631691.66694.97
极限148382-4838295.75493.482.1999.5497.262.15
246335-4633591.70395.36
347138-4713893.29297.00
448613-4861396.212100.09
546674-4667492.37496.18
646256-4625691.54795.36
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