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%
112.385124195121365126615129715124675125310.07
212.445145015159385152200.20
单位质量响应值RSD%判断
41399.9241416.400.03数据可信
供试品溶液-2025091921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%
5min127095-270955.2315.2721.385.235.2621.37
226568-265685.1295.13
336226-362266.9946.99
417882-178823.4523.45
527766-277665.3615.36
628131-281315.4315.43
10min147745-477459.2189.4311.049.229.4311.01
246780-467809.0329.03
355446-5544610.70510.70
439860-398607.6967.70
551787-517879.99810.00
651454-514549.9349.93
15min160682-6068211.71511.826.9511.7211.826.96
259541-5954111.49511.50
365611-6561112.66712.67
453828-5382810.39210.39
563806-6380612.31912.32
663811-6381112.32012.32
20min169288-6928813.37713.474.6313.3813.474.62
268236-6823613.17413.17
372797-7279714.05414.05
464316-6431612.41712.42
572644-7264414.02514.02
671321-7132113.76913.77
30min178917-7891715.23615.282.4515.2415.282.44
277473-7747314.95714.96
380216-8021615.48715.49
476318-7631814.73414.73
581238-8123815.68415.68
680666-8066615.57415.57
45min184360-8436016.28716.561.9216.2916.561.91
284453-8445316.30516.30
386521-8652116.70416.70
484470-8447016.30816.31
588435-8843517.07417.07
686416-8641616.68416.68
极限189532-8953217.28517.451.9217.2917.451.91
288038-8803816.99717.00
390237-9023717.42117.42
490265-9026517.42717.43
593264-9326418.00618.01
690965-9096517.56217.56
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%
112.385138215156505141015136275142805142960.16
212.445171745191155181440.27
单位质量响应值RSD%判断
41542.4941651.450.19数据可信
供试品溶液-2025092021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%
5min137601-376017.2266.7232.177.236.7232.17
222801-228014.3824.38
325628-256284.9254.93
428367-283675.4525.45
550982-509829.7989.80
644477-444778.5488.55
10min157819-5781911.11210.3112.1511.1110.3112.15
247033-470339.0399.04
349390-493909.4929.49
447476-474769.1249.12
562545-6254512.02012.02
657602-5760211.07011.07
15min167847-6784713.03912.297.3713.0412.307.38
260039-6003911.53911.54
361661-6166111.85011.85
458074-5807411.16111.16
569887-6988713.43113.43
666327-6632712.74712.75
20min174533-7453314.32413.595.5514.3213.595.53
269565-6956513.37013.37
369308-6930813.32013.32
464193-6419312.33712.34
574423-7442314.30314.30
672343-7234313.90313.90
30min181950-8195015.75015.213.1715.7515.213.17
278923-7892315.16815.17
379252-7925215.23115.23
474513-7451314.32014.32
580250-8025015.42315.42
680041-8004115.38315.38
45min186888-8688816.69916.352.0916.7016.352.09
286835-8683516.68916.69
384400-8440016.22116.22
482251-8225115.80815.81
584344-8434416.21016.21
685707-8570716.47216.47
极限192263-9226317.73217.341.5317.7317.341.53
291593-9159317.60317.60
389509-8950917.20317.20
489444-8944417.19017.19
588737-8873717.05417.05
689937-8993717.28517.28
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%
112.385139215153745143445155585143745147140.14
212.445142865144545143700.03
单位质量响应值RSD%判断
41576.2541348.070.39数据可信
供试品溶液-2025091921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%
5min137872-378727.3026.4415.047.306.4415.04
237332-373327.1987.20
337068-370687.1477.15
430630-306305.9065.91
532206-322066.2106.21
625156-251564.8504.85
10min159637-5963711.49910.696.9011.5010.696.91
258752-5875211.32811.33
357882-5788211.16011.16
450848-508489.8049.80
554109-5410910.43310.43
651487-514879.9279.93
15min170478-7047813.58912.735.0013.5912.735.02
268710-6871013.24813.25
367063-6706312.93112.93
461936-6193611.94211.94
564888-6488812.51112.51
663133-6313312.17312.17
20min175338-7533814.52613.933.6714.5313.933.67
274263-7426314.31914.32
373467-7346714.16514.17
468195-6819513.14913.15
571836-7183613.85113.85
670430-7043013.58013.58
30min180730-8073015.56615.171.9115.5715.171.92
279031-7903115.23815.24
379564-7956415.34115.34
476287-7628714.70914.71
578309-7830915.09915.10
678120-7812015.06315.06
45min184166-8416616.22815.981.2716.2315.981.29
283283-8328316.05816.06
383379-8337916.07716.08
481030-8103015.62415.62
582887-8288715.98215.98
682658-8265815.93815.94
极限186676-8667616.71216.700.5716.7116.700.56
286438-8643816.66616.67
386077-8607716.59716.60
486144-8614416.61016.61
587361-8736116.84416.84
686926-8692616.76016.76
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%
112.385190295191475209465198875211145200250.19
212.445202715195365199040.10
单位质量响应值RSD%判断
42005.2541792.930.36数据可信
供试品溶液-2025092021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%
5min139215-392157.4827.379.477.487.379.46
235851-358516.8406.84
340757-407577.7777.78
432836-328366.2656.27
540286-402867.6877.69
642870-428708.1808.18
10min159979-5997911.44411.394.5311.4411.394.53
257855-5785511.03911.04
362665-6266511.95711.96
455293-5529310.55010.55
561241-6124111.68511.68
661272-6127211.69111.69
15min170559-7055913.46313.343.6013.4613.343.59
267255-6725512.83212.83
372842-7284213.89813.90
466489-6648912.68612.69
571558-7155813.65313.65
670942-7094213.53613.54
20min175524-7552414.41014.432.4114.4114.432.42
274026-7402614.12414.12
377879-7787914.86014.86
473025-7302513.93313.93
576551-7655114.60614.61
676749-7674914.64414.64
30min180921-8092115.44015.451.6815.4415.451.68
279565-7956515.18115.18
382199-8219915.68415.68
479141-7914115.10015.10
582324-8232415.70815.71
681712-8171215.59115.59
45min184360-8436016.09616.161.3216.1016.161.32
283677-8367715.96615.97
386094-8609416.42716.43
483208-8320815.87615.88
585373-8537316.28916.29
685375-8537516.29016.29
极限187598-8759816.71416.790.8116.7116.790.81
287360-8736016.66916.67
388766-8876616.93716.94
487083-8708316.61616.62
588543-8854316.89416.89
688495-8849516.88516.89
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