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ZZ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%
111.037233572413722737205472183722520.20
211.037368072079728801.56
单位质量响应值RSD%判断
6550.506607.430.62数据可信
供试品溶液-J057M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%
5min16445-64458.7909.014.758.799.014.75
27227-72279.8569.86
36422-64228.7588.76
46413-64138.7468.75
56606-66069.0099.01
66518-65188.8898.89
10min112902-1290217.59517.392.0817.6117.402.08
213104-1310417.87117.89
312640-1264017.23817.25
412371-1237116.87116.89
512587-1258717.16617.18
612887-1288717.57517.59
15min117335-1733523.64123.611.5423.6923.661.54
217596-1759623.99724.04
317359-1735923.67423.72
416946-1694623.11123.15
517057-1705723.26223.31
617582-1758223.97824.02
20min120933-2093328.54828.112.4228.6328.202.42
221057-2105728.71728.80
319855-1985527.07827.16
420192-2019227.53727.62
520598-2059828.09128.17
621047-2104728.70328.79
30min125960-2596035.40435.071.1435.5335.201.13
226038-2603835.51035.64
325479-2547934.74834.88
425305-2530534.51034.64
525626-2562634.94835.08
625889-2588935.30735.44
45min131388-3138842.80642.151.2943.0042.341.30
230956-3095642.21742.41
330768-3076841.96142.15
430354-3035441.39641.58
530659-3065941.81242.00
631325-3132542.72042.91
60min135113-3511347.88647.061.3048.1547.321.30
234623-3462347.21847.48
334142-3414246.56246.82
434006-3400646.37746.63
534242-3424246.69946.96
634911-3491147.61147.87
90min140199-4019954.82353.921.1255.1654.261.12
239557-3955753.94754.29
338853-3885352.98753.32
439465-3946553.82254.15
539392-3939253.72254.06
639750-3975054.21054.55
120min143579-4357959.43258.561.0359.8658.991.03
242964-4296458.59359.03
342451-4245157.89458.32
442799-4279958.36858.79
542525-4252557.99558.42
643311-4331159.06759.50
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144778-4477861.06760.430.7261.6060.960.73
244339-4433960.46961.00
343828-4382859.77260.29
444138-4413860.19560.71
544307-4430760.42560.95
644474-4447460.65361.18
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ZZ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%
111.033641236107364353642436274363300.39
211.033569435845357700.30
单位质量响应值RSD%判断
3293.743242.971.10数据可信
供试品溶液-J187N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%
5min13772-377210.3559.718.1610.369.718.16
23945-394510.83010.83
33139-31398.6188.62
43479-34799.5519.55
53537-35379.7109.71
63354-33549.2089.21
10min17427-742720.38919.865.1820.4119.885.18
27657-765721.02121.04
36725-672518.46218.48
47581-758120.81220.83
57019-701919.26919.29
66990-699019.19019.21
15min110113-1011327.76327.163.3327.8127.213.33
210185-1018527.96128.01
39493-949326.06126.11
410261-1026128.17028.22
59621-962126.41326.46
69697-969726.62126.67
20min112526-1252634.38833.023.3434.4933.113.34
212465-1246534.22034.32
311558-1155831.73031.82
412082-1208233.16933.27
511769-1176932.30932.40
611759-1175932.28232.37
30min115311-1531142.03341.093.0842.1941.243.08
215421-1542142.33542.49
314898-1489840.90041.04
415333-1533342.09442.25
514374-1437439.46139.61
614475-1447539.73839.88
45min118319-1831950.29148.933.6050.5249.153.60
218552-1855250.93151.16
317639-1763948.42448.63
418188-1818849.93250.15
516876-1687646.33046.54
617367-1736747.67847.89
60min120499-2049956.27655.051.8256.5855.351.83
220287-2028755.69456.01
319869-1986954.54654.84
420261-2026155.62355.93
519906-1990654.64854.94
619494-1949453.51753.81
90min123613-2361364.82562.962.4065.2363.352.40
223470-2347064.43264.84
322523-2252361.83262.21
423144-2314463.53763.94
522526-2252661.84162.22
622321-2232161.27861.66
120min125327-2532769.53068.301.5670.0468.801.57
225165-2516569.08669.60
324410-2441067.01367.50
425056-2505668.78669.29
524902-2490268.36468.85
624413-2441367.02167.50
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126483-2648372.70471.191.4973.3371.801.50
226181-2618171.87572.50
325494-2549469.98970.58
426106-2610671.66972.29
525644-2564470.40171.00
625672-2567270.47771.07
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