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10000
标示量(mg)1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%
110.386777567308675116743067488675020.26
210.406718567575673800.41
单位质量响应值RSD%判断
6503.086478.850.27数据可信
供试品溶液-2025072522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%
5min111754-1175416.24715.6511.7916.2515.6511.79
213345-1334518.44618.45
39873-987313.64713.65
49781-978113.52013.52
511644-1164416.09516.09
611515-1151515.91715.92
10min119152-1915226.47325.225.5526.5025.255.55
219205-1920526.54626.58
317167-1716723.72923.75
416942-1694223.41823.44
518938-1893826.17726.20
618084-1808424.99725.02
15min123661-2366132.70531.773.1532.7831.843.16
223694-2369432.75132.83
322085-2208530.52730.59
422145-2214530.61030.67
523352-2335232.27832.35
622976-2297631.75931.83
20min126912-2691237.19936.472.2237.3236.582.23
227124-2712437.49237.62
325959-2595935.88235.99
425676-2567635.49135.60
526619-2661936.79436.92
626003-2600335.94336.06
30min131556-3155643.61842.871.4143.8143.051.43
231129-3112943.02843.22
330603-3060342.30142.47
430423-3042342.05242.22
531375-3137543.36843.55
630989-3098942.83543.02
45min135869-3586949.58048.980.9549.8449.230.96
235619-3561949.23449.50
335286-3528648.77449.02
435067-3506748.47148.71
535674-3567449.31049.57
635085-3508548.49648.75
60min138639-3863953.40952.961.3353.7553.291.34
238707-3870753.50353.85
338372-3837253.04053.36
437669-3766952.06852.39
538796-3879653.62653.97
637696-3769652.10552.44
90min142641-4264158.94058.611.1159.3759.041.12
242635-4263558.93259.37
342233-4223358.37758.79
442202-4220258.33458.74
543037-4303759.48859.92
641681-4168157.61458.03
120min145024-4502462.23462.050.9262.7662.570.92
244735-4473561.83562.37
344939-4493962.11762.63
445032-4503262.24562.75
545425-4542562.78963.32
644188-4418861.07961.59
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145533-4553362.93863.051.0163.5763.681.00
245463-4546362.84163.48
345618-4561863.05563.67
445470-4547062.85163.46
546481-4648164.24864.88
645125-4512562.37462.99
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10000
标示量(mg)1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%
110.386714867093671826693267120670950.15
210.406734367236672900.12
单位质量响应值RSD%判断
6463.876470.190.07数据可信
供试品溶液-2025072522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%
5min111876-1187616.47615.2313.7916.4815.2313.80
29179-917912.73512.73
312580-1258017.45317.45
412335-1233517.11317.11
59283-928312.87912.88
610612-1061214.72314.72
10min118028-1802825.01124.656.0125.0424.686.03
216977-1697723.55323.57
318999-1899926.35826.39
418822-1882226.11326.14
516241-1624122.53222.55
617551-1755124.35024.37
15min122840-2284031.68731.213.3331.7631.273.34
221749-2174930.17430.23
323244-2324432.24832.32
423146-2314632.11232.18
521432-2143229.73429.79
622552-2255231.28831.35
20min126166-2616636.30236.212.8736.4236.332.88
226087-2608736.19236.30
326929-2692937.36037.49
426678-2667837.01237.14
524776-2477634.37334.48
625983-2598336.04836.17
30min130579-3057942.42442.272.5742.6142.452.57
230374-3037442.14042.31
331373-3137343.52643.71
431100-3110043.14743.33
529146-2914640.43640.60
630231-3023141.94142.12
45min135039-3503948.61248.462.0348.8648.712.04
234722-3472248.17248.41
335518-3551849.27649.54
435620-3562049.41849.68
533658-3365846.69646.93
635028-3502848.59648.84
60min137853-3785352.51652.671.2052.8553.001.22
237852-3785252.51452.84
338487-3848753.39553.74
438495-3849553.40653.75
537314-3731451.76852.08
637789-3778952.42752.76
90min141662-4166257.80057.801.2258.2258.221.23
241808-4180858.00358.41
342149-4214958.47658.91
441863-4186358.07958.51
540683-4068356.44256.84
641793-4179357.98258.40
120min144474-4447461.70161.351.0662.2261.861.07
244265-4426561.41161.92
344629-4462961.91662.45
444508-4450861.74962.28
543353-4335360.14660.64
644085-4408561.16261.67
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145014-4501462.45162.570.6863.0763.190.69
245118-4511862.59563.20
345438-4543863.03963.67
445252-4525262.78163.41
544556-4455661.81562.41
645235-4523562.75763.37
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