多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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 10.193261232757328243276332867327650.30
2 10.203278332876328300.21
单位质量响应值RSD%判断
3215.413218.630.08数据可信
供试品溶液-H147S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%
5min13111-31118.6768.897.168.688.897.19
23231-32319.0119.01
33024-30248.4348.43
43214-32148.9648.96
52945-29458.2138.21
63595-359510.02610.03
10min16715-671518.72819.665.5018.7419.675.50
27104-710419.81319.83
36810-681018.99319.01
47052-705219.66819.68
56834-683419.06019.07
67778-777821.69221.71
15min19271-927125.85627.475.1825.9027.525.19
29920-992027.66627.71
39522-952226.55626.60
410038-1003827.99528.04
59626-962626.84626.89
610726-1072629.91429.97
20min111772-1177232.83233.983.9632.9234.073.97
212153-1215333.89433.99
311921-1192133.24733.34
412341-1234134.41834.51
511844-1184433.03233.12
613067-1306736.44336.55
30min114945-1494541.68142.843.0641.8242.993.06
215500-1550043.22943.38
314934-1493441.65041.80
415553-1555343.37743.53
515082-1508242.06342.21
616142-1614245.01945.18
45min118096-1809650.46952.102.8550.6852.322.85
218552-1855251.74151.96
319275-1927553.75753.97
418735-1873552.25152.48
518128-1812850.55850.77
619304-1930453.83854.08
60min120286-2028656.57757.902.2056.8758.212.21
220731-2073157.81858.13
320649-2064957.58957.89
420981-2098158.51558.83
520380-2038056.83957.14
621541-2154160.07760.41
90min123204-2320464.71566.482.3365.1166.882.32
224306-2430667.78868.19
323367-2336765.16965.57
424212-2421267.52667.93
523459-2345965.42665.82
624473-2447368.25468.68
120min125018-2501869.77471.892.0870.2772.402.08
225980-2598072.45772.98
325449-2544970.97671.48
426272-2627273.27173.79
525530-2553071.20271.71
626404-2640473.63974.18
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126116-2611672.83674.151.8173.4574.791.81
226789-2678974.71375.35
326267-2626773.25773.88
427137-2713775.68476.33
526119-2611972.84573.47
627097-2709775.57276.24
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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 10.193289732963331083288932958329630.27
2 10.203289232969329300.17
单位质量响应值RSD%判断
3234.843228.430.15数据可信
供试品溶液-H149S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%
5min13291-32919.13710.469.419.1410.469.40
23830-383010.63310.63
33512-35129.7509.75
43653-365310.14210.14
54091-409111.35811.36
64230-423011.74411.74
10min17210-721020.01721.033.9620.0321.053.96
27689-768921.34721.36
37377-737720.48120.50
47362-736220.43920.46
57900-790021.93321.95
67911-791121.96421.98
15min110182-1018228.26928.972.2128.3229.022.22
210652-1065229.57429.63
310303-1030328.60528.65
410216-1021628.36328.41
510542-1054229.26829.32
610713-1071329.74329.80
20min112403-1240334.43534.971.1834.5335.081.19
212601-1260134.98535.09
312686-1268635.22135.32
412442-1244234.54334.64
512662-1266235.15435.26
612788-1278835.50435.61
30min115461-1546142.92543.411.3443.0843.571.34
215897-1589744.13544.30
315637-1563743.41443.57
415328-1532842.55642.71
515762-1576243.76143.92
615727-1572743.66343.83
45min118568-1856851.55151.701.0451.7851.931.04
218902-1890252.47852.71
318547-1854751.49351.72
418355-1835550.96051.19
518566-1856651.54551.78
618782-1878252.14552.38
60min120916-2091658.07057.741.0258.3858.051.01
221141-2114158.69559.02
320820-2082057.80358.12
420652-2065257.33757.65
520567-2056757.10157.42
620676-2067657.40457.73
90min124034-2403466.72666.151.2067.1366.561.19
224082-2408266.86067.28
323895-2389566.34166.75
423953-2395366.50266.91
523328-2332864.76665.18
623661-2366165.69166.11
120min126172-2617272.66271.431.5173.1871.951.50
226099-2609972.46072.99
325902-2590271.91372.43
425469-2546970.71171.23
525201-2520169.96670.49
625528-2552870.87471.40
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126771-2677174.32573.711.1974.9674.351.18
226970-2697074.87875.53
326536-2653673.67374.31
426456-2645673.45174.09
526040-2604072.29672.94
626521-2652173.63174.28
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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 10.193342433368334123334033367333820.11
2 10.203282232796328090.06
单位质量响应值RSD%判断
3275.963216.571.30数据可信
供试品溶液-H149S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%
5min15888-588816.27516.0513.3616.2716.0513.36
24465-446512.34212.34
36235-623517.23417.23
46731-673118.60518.60
55479-547915.14415.14
66048-604816.71716.72
10min111440-1144031.62131.236.9831.6531.266.99
29847-984727.21827.24
311675-1167532.27032.30
412145-1214533.56933.60
511098-1109830.67530.70
611585-1158532.02232.05
15min115093-1509341.71841.912.6341.8041.992.65
214499-1449940.07640.14
315475-1547542.77442.86
415662-1566243.29143.38
515131-1513141.82341.90
615124-1512441.80441.88
20min117976-1797649.68749.202.4349.8449.352.43
217005-1700547.00347.14
317802-1780249.20649.36
418286-1828650.54450.70
517760-1776049.09049.24
617968-1796849.66549.82
30min121314-2131458.91358.932.2359.1559.162.24
220427-2042756.46156.67
321565-2156559.60759.84
421821-2182160.31460.56
521403-2140359.15959.39
621393-2139359.13159.37
45min125524-2552470.55068.852.2370.8869.182.24
223973-2397366.26366.57
324823-2482368.61268.95
425422-2542270.26870.61
524925-2492568.89469.22
624786-2478668.51068.84
60min126980-2698074.57474.391.8575.0274.831.85
225937-2593771.69172.11
326948-2694874.48674.94
427233-2723375.27475.73
527283-2728375.41275.85
627100-2710074.90675.35
90min129444-2944481.38581.681.7581.9682.251.76
228549-2854978.91179.45
329849-2984982.50483.08
429797-2979782.36182.95
529894-2989482.62983.20
629770-2977082.28682.86
120min131250-3125086.37786.321.9487.0887.021.94
230054-3005483.07183.74
331620-3162087.39988.11
431234-3123486.33387.06
531647-3164787.47488.18
631563-3156387.24287.95
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131717-3171787.66887.511.1888.5288.361.19
230952-3095285.55386.36
331901-3190188.17689.03
431574-3157487.27288.14
531908-3190888.19589.05
631902-3190288.17989.03
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