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 12.345169545156695165595164375158425162920.11
2 12.375162585156475159520.09
单位质量响应值RSD%判断
41838.9041709.940.22数据可信
供试品溶液-2025091821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%
5min111784-117842.2553.0332.262.263.0332.21
219339-193393.7013.70
311572-115722.2152.21
424472-244724.6834.68
514677-146772.8092.81
613096-130962.5062.51
10min138790-387907.4237.868.707.427.868.70
243012-430128.2318.23
337354-373547.1487.15
446461-464618.8918.89
542858-428588.2028.20
638096-380967.2907.29
15min153880-5388010.31110.686.5310.3110.686.53
258371-5837111.17111.17
351406-514069.8389.84
460184-6018411.51711.52
558521-5852111.19911.20
652600-5260010.06610.07
20min163135-6313512.08212.535.8712.0812.535.86
267714-6771412.95912.96
360643-6064311.60511.61
470525-7052513.49613.50
568105-6810513.03313.03
662754-6275412.00912.01
30min175680-7568014.48314.775.2014.4814.775.22
279566-7956615.22715.23
370297-7029713.45313.45
481574-8157415.61115.61
579456-7945615.20615.21
676422-7642214.62514.62
45min185545-8554516.37116.553.8416.3716.553.84
288089-8808916.85816.86
380582-8058215.42115.42
489981-8998117.22017.22
588592-8859216.95416.95
686223-8622316.50116.50
极限194566-9456618.09718.213.2818.1018.213.27
296132-9613218.39718.40
389227-8922717.07517.08
497289-9728918.61818.62
597800-9780018.71618.72
695821-9582118.33718.34
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 12.345176195173525185005194105196725185110.20
2 12.375280485280185280330.01
单位质量响应值RSD%判断
42018.7242686.581.12数据可信
供试品溶液-2025091921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%
5min19904-99041.8703.1150.411.873.1250.42
224624-246244.6484.65
38436-84361.5921.59
426567-265675.0155.02
520338-203383.8393.84
69091-90911.7161.72
10min132362-323626.1097.3125.326.117.3225.29
247053-470538.8828.88
323504-235044.4374.44
447892-478929.0419.04
545670-456708.6218.62
636017-360176.7996.80
15min151678-516789.75510.0917.769.7610.0917.76
260376-6037611.39711.40
336337-363376.8596.86
461328-6132811.57711.58
559737-5973711.27711.28
651284-512849.6819.68
20min162936-6293611.88012.0012.8711.8812.0012.87
269184-6918413.06013.06
348889-488899.2299.23
470271-7027113.26513.27
569406-6940613.10213.10
660733-6073311.46511.46
30min175372-7537214.22814.358.5514.2314.358.55
280769-8076915.24715.25
364342-6434212.14612.15
481368-8136815.36015.36
580309-8030915.16015.16
673841-7384113.93913.94
45min185882-8588216.21216.294.9616.2116.294.96
289474-8947416.89016.89
378843-7884314.88314.88
489866-8986616.96416.96
589345-8934516.86616.87
684426-8442615.93715.94
极限195150-9515017.96117.814.1517.9617.814.15
296907-9690718.29318.29
386717-8671716.37016.37
495936-9593618.11018.11
597246-9724618.35718.36
694062-9406217.75617.76
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%
1 12.345144135153305145835156635145045148990.11
2 12.375217465223015220240.08
单位质量响应值RSD%判断
41726.0142200.810.81数据可信
供试品溶液-2025092021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%
5min14993-49930.9513.5767.660.953.5767.71
232542-325426.2006.20
39735-97351.8551.85
432448-324486.1826.18
57884-78841.5021.50
624799-247994.7254.72
10min133020-330206.2918.2423.766.298.2423.76
252663-5266310.03310.03
333896-338966.4586.46
452939-5293910.08610.09
534780-347806.6266.63
652311-523119.9669.97
15min150974-509749.71110.9411.889.7110.9411.87
263663-6366312.12912.13
351625-516259.8359.84
464024-6402412.19812.20
551000-510009.7169.72
663196-6319612.04012.04
20min161718-6171811.75812.828.1511.7612.828.16
272064-7206413.72913.73
363299-6329912.05912.06
471994-7199413.71613.72
561952-6195211.80311.80
672754-7275413.86113.86
30min176423-7642314.56015.025.1614.5615.025.15
281613-8161315.54815.55
372895-7289513.88813.89
482104-8210415.64215.64
576721-7672114.61614.62
683139-8313915.83915.84
45min186639-8663916.50616.743.4516.5116.743.43
289437-8943717.03917.04
382646-8264615.74515.75
489977-8997717.14217.14
587486-8748616.66716.67
691035-9103517.34417.34
极限196114-9611418.31118.233.2418.3118.233.25
296282-9628218.34318.34
389508-8950817.05317.05
496784-9678418.43918.44
597597-9759718.59418.59
697768-9776818.62618.63
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