他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.342604732614402603022607662617282609420.24
212.372618962627022622990.22
单位质量响应值RSD%判断
21146.0321204.450.20数据可信
供试品溶液-2025091722批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122234-222348.3946.8624.828.396.8624.81
216467-164676.2176.22
319581-195817.3937.39
410702-107024.0404.04
522988-229888.6798.68
617057-170576.4406.44
10min143087-4308716.26714.8015.0616.2714.8015.07
238812-3881214.65314.65
341668-4166815.73115.73
427923-2792310.54210.54
544266-4426616.71216.71
639515-3951514.91814.92
15min152439-5243919.79818.849.1319.8018.849.12
250809-5080919.18219.18
350586-5058619.09819.10
440835-4083515.41715.42
553302-5330220.12320.12
651384-5138419.39919.40
20min159255-5925522.37121.815.9622.3721.805.97
258960-5896022.26022.26
357107-5710721.56021.56
451157-5115719.31419.31
560790-6079022.95022.95
659277-5927722.37922.38
30min168098-6809825.70925.503.5725.7125.503.56
269162-6916226.11126.11
366283-6628325.02425.02
463248-6324823.87823.88
569487-6948726.23426.23
669017-6901726.05626.06
45min176895-7689529.03129.052.0629.0329.052.05
278142-7814229.50129.50
374873-7487328.26728.27
475161-7516128.37628.38
578351-7835129.58029.58
678192-7819229.52029.52
极限185778-8577832.38432.511.0332.3832.511.03
286607-8660732.69732.70
384541-8454131.91731.92
486072-8607232.49532.50
586820-8682032.77832.78
686851-8685132.78932.79
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.342644642632172637542645042638002639480.21
212.372650112650832650470.02
单位质量响应值RSD%判断
21389.6321426.600.13数据可信
供试品溶液-2025091722批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113158-131584.9146.6528.784.916.6528.80
211568-115684.3204.32
323827-238278.8988.90
415248-152485.6945.69
521856-218568.1628.16
621213-212137.9227.92
10min133501-3350112.51014.3914.7112.5114.3914.70
231623-3162311.80911.81
344722-4472216.70016.70
435539-3553913.27113.27
543813-4381316.36116.36
642050-4205015.70315.70
15min144972-4497216.79418.4110.4616.7918.4110.47
244572-4457216.64416.64
355725-5572520.80920.81
444662-4466216.67816.68
554023-5402320.17420.17
651898-5189819.38019.38
20min154346-5434620.29421.506.4820.2921.496.48
253936-5393620.14120.14
362643-6264323.39323.39
454710-5471020.43020.43
560680-6068022.66022.66
659057-5905722.05422.05
30min166393-6639324.79325.472.7224.7925.472.73
266476-6647624.82424.82
371070-7107026.54026.54
467515-6751525.21225.21
569684-6968426.02226.02
668095-6809525.42925.43
45min177547-7754728.95828.921.2728.9628.921.26
276990-7699028.75028.75
379091-7909129.53529.53
477702-7770229.01629.02
577246-7724628.84628.85
676120-7612028.42528.43
极限187467-8746732.66332.570.4432.6632.570.44
287829-8782932.79832.80
387238-8723832.57732.58
486790-8679032.41032.41
587062-8706232.51132.51
686944-8694432.46732.47
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