多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.013587435993360543594235967359660.19
211.113562435560355920.13
单位质量响应值RSD%判断
3266.673203.601.38数据可信
供试品溶液-J187N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%
5min15105-510514.18915.926.0114.1915.926.01
25630-563015.64815.65
36113-611316.99116.99
45814-581416.16016.16
55914-591416.43816.44
65788-578816.08716.09
10min110497-1049729.17631.043.8629.2031.073.86
211118-1111830.90230.93
311692-1169232.49732.53
411271-1127131.32731.35
511523-1152332.02732.05
610914-1091430.33530.36
15min114324-1432439.81341.462.5639.8841.542.56
214747-1474740.98841.07
315262-1526242.42042.50
414977-1497741.62841.71
515377-1537742.73942.82
614818-1481841.18641.26
20min116866-1686646.87848.702.2947.0248.842.30
217452-1745248.50748.65
317660-1766049.08549.24
417742-1774249.31349.46
518045-1804550.15550.31
617353-1735348.23248.38
30min120558-2055857.14058.141.2857.3658.371.29
220984-2098458.32458.55
321145-2114558.77159.01
420906-2090658.10758.34
521246-2124659.05259.29
620667-2066757.44357.67
45min124688-2468868.61968.080.6368.9368.400.62
224656-2465668.53068.85
324433-2443367.91068.24
424284-2428467.49667.82
524460-2446067.98568.32
624440-2444067.92968.25
60min126455-2645573.53073.700.9973.9674.140.98
226973-2697374.97075.41
326221-2622172.88073.33
426349-2634973.23573.68
526466-2646673.56174.01
626628-2662874.01174.45
90min129125-2912580.95181.161.1181.5081.721.10
229775-2977582.75883.32
328863-2886380.22380.79
428947-2894780.45681.02
529272-2927281.36081.93
629208-2920881.18281.74
120min130975-3097586.09385.770.9086.7886.470.90
231210-3121086.74687.45
330737-3073785.43286.13
430530-3053084.85685.55
531098-3109886.43587.14
630606-3060685.06785.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限131366-3136687.18087.560.5188.0188.400.51
231524-3152487.61988.46
331383-3138387.22788.07
431494-3149487.53688.37
531798-3179888.38189.23
631442-3144287.39188.23
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.017104771151709077110071097710600.14
211.117296273388731750.42
单位质量响应值RSD%判断
6454.136586.411.44数据可信
供试品溶液-J057M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%
5min110450-1045014.41114.441.4614.4114.441.44
210493-1049314.47114.47
310207-1020714.07614.08
410661-1066114.70214.70
510568-1056814.57414.57
610467-1046714.43514.43
10min118717-1871725.81226.562.0125.8426.582.01
219588-1958827.01327.04
318912-1891226.08126.10
419569-1956926.98727.01
519602-1960227.03327.06
619168-1916826.43426.46
15min125055-2505534.55335.421.6834.6235.491.69
226026-2602635.89235.96
325309-2530934.90334.97
426196-2619636.12636.20
525780-2578035.55235.62
625757-2575735.52135.59
20min129732-2973241.00341.781.0741.1341.901.07
230444-3044441.98442.11
330228-3022841.68741.81
430687-3068742.32042.45
530235-3023541.69641.82
630432-3043241.96842.10
30min136462-3646250.28450.730.7250.4850.930.72
237196-3719651.29651.49
336608-3660850.48550.68
436844-3684450.81151.01
536669-3666950.56950.77
636938-3693850.94051.14
45min142457-4245758.55159.371.0158.8359.651.01
243496-4349659.98460.27
343028-4302859.33959.62
442836-4283659.07459.36
542879-4287959.13359.42
643604-4360460.13360.42
60min147087-4708764.93665.480.9365.3165.860.93
248008-4800866.20766.59
347460-4746065.45165.83
447321-4732165.25965.64
547008-4700864.82765.21
648011-4801166.21166.59
90min152726-5272672.71372.820.6673.2073.310.66
252903-5290372.95773.45
352701-5270172.67873.17
452520-5252072.42972.92
552516-5251672.42372.91
653443-5344373.70274.19
120min156861-5686178.41577.910.5779.0278.520.56
256704-5670478.19978.82
356361-5636177.72678.33
456161-5616177.45078.06
556126-5612677.40278.01
656737-5673778.24478.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限157478-5747879.26679.040.4980.0079.780.49
257277-5727778.98979.74
357326-5732679.05779.79
457280-5728078.99379.74
556845-5684578.39379.13
657676-5767679.53980.29
多替诺雷非布司他片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.015445305462065482145494105501555477030.43
211.115488145493265490700.07
单位质量响应值RSD%判断
49745.9649421.240.47数据可信
供试品溶液-4229B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%
5min158518-5851810.61111.2510.2410.6111.2510.24
267247-6724712.19412.19
365253-6525311.83211.83
467511-6751112.24212.24
562770-6277011.38211.38
651022-510229.2529.25
10min193374-9337416.93216.654.8416.9516.674.84
292233-9223316.72516.75
387369-8736915.84315.86
497046-9704617.59817.62
595194-9519417.26217.28
685716-8571615.54315.56
15min1106341-10634119.28317.6114.3219.3317.6614.28
2110335-11033520.00720.06
3104011-10401118.86118.91
471650-7165012.99213.04
596288-9628817.46017.51
694072-9407217.05817.10
20min187220-8722015.81618.589.2115.8918.659.18
2112777-11277720.45020.53
3110562-11056220.04820.13
497054-9705417.59917.67
5101511-10151118.40718.48
6105597-10559719.14819.22
30min1115735-11573520.98618.8110.2421.0918.9210.14
291988-9198816.68016.80
393902-9390217.02717.14
4114931-11493120.84120.94
597574-9757417.69317.80
6108354-10835419.64819.75
45min1118639-11863921.51317.8512.2121.6517.9812.10
290034-9003416.32616.47
3102577-10257718.60018.74
493062-9306216.87517.01
584758-8475815.36915.51
6101458-10145818.39818.53
60min198579-9857917.87618.078.4218.0518.248.33
286953-8695315.76715.94
3108178-10817819.61619.79
4102501-10250118.58718.75
593607-9360716.97417.14
6108127-10812719.60719.77
90min1108925-10892519.75218.0113.9519.9618.2113.81
291754-9175416.63816.83
3105152-10515219.06719.27
4105562-10556219.14219.34
5110104-11010419.96520.16
674408-7440813.49313.69
120min174246-7424613.46316.7120.7713.7016.9420.48
275072-7507213.61313.84
3117823-11782321.36521.60
481695-8169514.81415.04
590861-9086116.47616.70
6113332-11333220.55120.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1103770-10377018.81716.7613.8719.0817.0213.65
288357-8835716.02216.27
369871-6987112.67012.94
492159-9215916.71116.96
595546-9554617.32617.58
6105006-10500619.04119.30
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2026-05-21 15:22:04 完成)
生成报告数据部分下载报告( 于 2026-05-23 05:53:49 完成)
Current page cost:52 ms