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%
1 12.681279251279561277581278421282551279470.15
2 12.671287201292561289880.30
单位质量响应值RSD%判断
10090.4610180.580.63数据可信
供试品溶液-2025091521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%
5min112609-126099.9467.9632.029.957.9632.02
28626-86266.8046.80
311897-118979.3849.38
412647-126479.9769.98
510499-104998.2818.28
64281-42813.3773.38
10min126203-2620320.66818.0419.3820.6718.0419.37
220073-2007315.83315.83
323724-2372418.71318.71
428275-2827522.30222.30
523095-2309518.21718.22
615854-1585412.50512.51
15min133381-3338126.33024.1713.6426.3324.1713.64
227772-2777221.90621.91
331539-3153924.87724.88
435861-3586128.28628.29
531224-3122424.62824.63
624076-2407618.99018.99
20min139049-3904930.80128.5911.2430.8028.5911.24
233424-3342426.36426.36
336397-3639728.70928.71
441552-4155232.77532.77
536991-3699129.17729.18
630053-3005323.70523.70
30min147002-4700237.07435.257.8237.0735.267.82
242057-4205733.17333.17
345839-4583936.15636.16
448276-4827638.07838.08
546028-4602836.30536.31
638969-3896930.73730.74
45min155223-5522343.55842.304.9143.5642.304.91
251996-5199641.01341.01
354313-5431342.84042.84
456276-5627644.38944.39
554875-5487543.28443.28
649110-4911038.73638.74
极限166529-6652952.47652.022.3652.4852.022.36
265712-6571251.83151.83
365260-6526051.47551.47
467646-6764653.35753.36
567194-6719453.00053.00
663355-6335549.97249.97
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%
1 12.681284811285641285871290101289801287240.20
2 12.671286661288571287620.11
单位质量响应值RSD%判断
10151.7410162.750.08数据可信
供试品溶液-2025091522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%
5min116972-1697213.35812.8714.2713.3612.8714.28
214653-1465311.53311.53
316842-1684213.25613.26
420440-2044016.08816.09
515266-1526612.01512.02
613944-1394410.97510.97
10min130516-3051624.01822.768.3524.0222.768.36
227624-2762421.74221.74
327572-2757221.70121.70
432435-3243525.52825.53
529631-2963123.32223.32
625720-2572020.24320.24
15min140554-4055431.91931.125.2931.9231.125.29
237906-3790629.83429.83
339284-3928430.91930.92
443024-4302433.86333.86
539372-3937230.98830.99
637113-3711329.21029.21
20min147247-4724737.18636.682.3837.1936.682.39
245599-4559935.88935.89
346580-4658036.66136.66
448427-4842738.11538.12
546314-4631436.45236.45
645461-4546135.78135.78
30min153361-5336141.99941.921.8842.0041.921.88
252229-5222941.10841.11
353383-5338342.01642.02
455094-5509443.36343.36
552839-5283941.58841.59
652659-5265941.44641.45
45min160043-6004347.25847.121.4347.2647.121.43
258873-5887346.33746.34
359932-5993247.17047.17
461298-6129848.24548.25
559934-5993447.17247.17
659122-5912246.53346.53
极限169363-6936354.59354.411.2754.5954.421.26
268719-6871954.08654.09
368870-6887054.20554.21
470242-7024255.28555.28
569829-6982954.96054.96
667790-6779053.35553.36
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%
1 12.681294811300011294531293911293231295300.21
2 12.671292481289421290950.17
单位质量响应值RSD%判断
10215.3010189.030.19数据可信
供试品溶液-2025091621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%
5min111306-113068.8598.9710.838.868.9710.81
210508-105088.2348.23
312135-121359.5099.51
413328-1332810.44410.44
59795-97957.6757.68
611614-116149.1019.10
10min125979-2597920.35720.755.9720.3620.755.97
225858-2585820.26220.26
327678-2767821.68821.69
428745-2874522.52522.52
524181-2418118.94818.95
626448-2644820.72520.72
15min134684-3468427.17827.554.1327.1827.554.13
234176-3417626.78026.78
336234-3623428.39328.39
437324-3732429.24729.25
533295-3329526.09026.09
635258-3525827.62827.63
20min141031-4103132.15232.252.8832.1532.252.88
240426-4042631.67831.68
341629-4162932.62032.62
443237-4323733.88133.88
539826-3982631.20831.21
640787-4078731.96131.96
30min149577-4957738.84939.002.5038.8539.002.50
248631-4863138.10738.11
350484-5048439.55939.56
451809-5180940.59840.60
548466-4846637.97837.98
649677-4967738.92738.93
45min158367-5836745.73645.661.9545.7445.661.96
257634-5763445.16245.16
358613-5861345.92945.93
460108-6010847.10147.10
556675-5667544.41144.41
658237-5823745.63445.63
极限169935-6993554.80154.611.0254.8054.611.02
268992-6899254.06254.06
369344-6934454.33854.34
471000-7100055.63655.64
569499-6949954.45954.46
669402-6940254.38354.38
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