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%
112.341267341268341270071268991267091268370.10
212.371274671279251276960.26
单位质量响应值RSD%判断
10278.5310323.040.31数据可信
供试品溶液-2025091521批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12857-28572.2174.8370.982.224.8370.95
2-0.0000.00
36309-63094.8964.90
45992-59924.6504.65
511094-110948.6108.61
611092-110928.6098.61
10min124236-2423618.81018.6122.0718.8118.6122.09
218400-1840014.28014.28
330274-3027423.49623.50
423514-2351418.24918.25
517852-1785213.85513.85
629581-2958122.95822.96
15min134204-3420426.54626.1511.6326.5526.1511.63
229320-2932022.75522.76
338358-3835829.77029.77
433834-3383426.25926.26
529022-2902222.52422.52
637397-3739729.02429.02
20min139663-3966330.78230.947.6130.7830.947.61
235347-3534727.43327.43
343569-4356933.81433.81
441062-4106231.86831.87
537512-3751229.11329.11
642072-4207232.65232.65
30min146849-4684936.36036.436.0036.3636.436.00
242833-4283333.24333.24
350609-5060939.27839.28
447081-4708136.54036.54
545005-4500534.92834.93
649291-4929138.25538.25
45min154346-5434642.17842.304.4442.1842.304.44
251116-5111639.67139.67
357785-5778544.84744.85
455065-5506542.73642.74
552547-5254740.78240.78
656180-5618043.60143.60
极限163355-6335549.17049.072.2749.1749.072.28
262238-6223848.30348.30
364760-6476050.26050.26
463023-6302348.91248.91
561141-6114147.45247.45
664824-6482450.31050.31
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%
112.341270841271541268661267071268531269330.15
212.371270281267191268740.18
单位质量响应值RSD%判断
10286.3010256.590.21数据可信
供试品溶液-2025091522批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19191-91917.1537.8059.687.157.8059.67
24778-47783.7193.72
316544-1654412.87612.88
410631-106318.2748.27
52180-21801.6971.70
616833-1683313.10113.10
10min126875-2687520.91721.6821.6120.9221.6821.61
224844-2484419.33619.34
334284-3428426.68426.68
429350-2935022.84422.84
518145-1814514.12314.12
633606-3360626.15626.16
15min136672-3667228.54228.5813.6728.5428.5813.67
234048-3404826.50026.50
341494-4149432.29532.30
437703-3770329.34529.34
528474-2847422.16222.16
641917-4191732.62532.62
20min142566-4256633.13032.8910.5133.1332.8910.52
239578-3957830.80430.80
346191-4619135.95135.95
443302-4330233.70333.70
534989-3498927.23227.23
646944-4694436.53736.54
30min149997-4999738.91338.497.9838.9138.497.98
246689-4668936.33936.34
352781-5278141.08041.08
450080-5008038.97838.98
543260-4326033.67033.67
653937-5393741.98041.98
45min157323-5732344.61544.255.6144.6244.255.61
254782-5478242.63842.64
358926-5892645.86345.86
457539-5753944.78344.78
551750-5175040.27840.28
660781-6078147.30747.31
极限166218-6621851.53851.073.3851.5451.073.38
264374-6437450.10350.10
367146-6714652.26152.26
465748-6574851.17351.17
561963-6196348.22748.23
668243-6824353.11553.11
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%
112.341270021270381272251272141273451271650.12
212.371277611275341276480.13
单位质量响应值RSD%判断
10305.1110319.160.10数据可信
供试品溶液-2025091621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17583-75835.8795.7243.725.885.7243.71
26468-64685.0145.01
31853-18531.4371.44
410472-104728.1188.12
510693-106938.2908.29
67191-71915.5755.57
10min124283-2428318.82519.5017.3318.8319.5017.33
223038-2303817.86017.86
318809-1880914.58214.58
429010-2901022.49022.49
531019-3101924.04724.05
624735-2473519.17619.18
15min133882-3388226.26728.536.2226.2728.536.22
239872-3987230.91030.91
335942-3594227.86427.86
437525-3752529.09129.09
538649-3864929.96229.96
634917-3491727.06927.07
20min141522-4152232.19032.431.2532.1932.431.25
241724-4172432.34632.35
341676-4167632.30932.31
442893-4289333.25233.25
541645-4164532.28532.28
641558-4155832.21832.22
30min147958-4795837.17937.254.2637.1837.254.26
247357-4735736.71336.71
344382-4438234.40734.41
449704-4970438.53338.53
549877-4987738.66738.67
648991-4899137.98037.98
45min155448-5544842.98642.982.7042.9942.982.71
254723-5472342.42442.42
352825-5282540.95240.95
456776-5677644.01544.02
556682-5668243.94243.94
656163-5616343.54043.54
极限164397-6439749.92350.030.7749.9250.030.77
264740-6474050.18950.19
363698-6369849.38149.38
464416-6441649.93849.94
565083-6508350.45550.46
664893-6489350.30850.31
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