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 12.385097215075425103495104885098645095930.24
212.445152465143675148060.13
单位质量响应值RSD%判断
41162.6041383.120.38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%
5min123763-237634.6034.8336.214.604.8336.21
210696-106962.0722.07
319756-197563.8273.83
429919-299195.7955.80
536627-366277.0957.09
628771-287715.5735.57
10min142198-421988.1748.9516.568.178.9516.59
235630-356306.9016.90
341214-412147.9837.98
451048-510489.8889.89
555635-5563510.77610.78
651413-514139.9599.96
15min154098-5409810.47911.3310.6010.4811.3410.58
250629-506299.8079.81
354611-5461110.57810.58
463254-6325412.25212.25
566105-6610512.80412.80
662407-6240712.08812.09
20min164821-6482112.55613.136.7912.5613.146.77
261572-6157211.92611.93
365009-6500912.59212.59
471480-7148013.84613.85
572922-7292214.12514.12
671046-7104613.76113.76
30min176948-7694814.90515.042.6414.9015.042.64
274595-7459514.44914.45
376610-7661014.83914.84
478266-7826615.16015.16
580326-8032615.55915.56
679207-7920715.34215.34
45min184811-8481116.42816.481.1516.4316.481.16
283749-8374916.22216.22
385031-8503116.47016.47
484435-8443516.35516.35
585901-8590116.63916.64
686439-8643916.74316.74
极限191137-9113717.65317.631.3517.6517.631.34
290760-9076017.58017.58
392814-9281417.97817.98
491674-9167417.75717.76
589141-8914117.26617.27
690593-9059317.54817.55
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 12.385083655098565089615098675088475091790.13
212.445091305107045099170.22
单位质量响应值RSD%判断
41129.1640990.110.24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%
5min150273-502739.7889.4811.069.799.4811.09
244786-447868.7208.72
342961-429618.3658.36
457552-5755211.20611.21
551136-511369.9569.96
645548-455488.8688.87
10min162579-6257912.18411.917.3212.1811.907.34
257775-5777511.24911.25
356510-5651011.00311.00
467627-6762713.16713.17
564603-6460312.57812.58
657793-5779311.25211.25
15min169476-6947613.52713.365.5313.5313.365.53
265389-6538912.73112.73
365023-6502312.66012.66
474212-7421214.44914.45
571716-7171613.96313.96
665985-6598512.84712.85
20min174283-7428314.46314.553.8614.4614.553.85
272572-7257214.13014.13
372417-7241714.10014.10
479060-7906015.39315.39
577563-7756315.10215.10
672604-7260414.13614.14
30min180036-8003615.58315.802.4115.5815.802.42
279557-7955715.49015.49
379939-7993915.56415.56
483513-8351316.26016.26
583751-8375116.30716.31
679977-7997715.57215.57
45min184083-8408316.37116.711.2816.3716.711.29
285158-8515816.58016.58
385884-8588416.72216.72
486589-8658916.85916.86
587190-8719016.97616.98
686056-8605616.75516.76
极限188108-8810817.15517.461.4417.1517.461.44
289348-8934817.39617.40
389638-8963817.45317.45
489892-8989217.50217.50
591995-9199517.91217.91
689154-8915417.35917.36
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 12.385106675116325122195141195122475121770.25
212.445087365098155092760.15
单位质量响应值RSD%判断
41371.3240938.590.75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%
5min140789-407897.9246.2418.567.926.2418.53
233093-330936.4296.43
325929-259295.0375.04
436201-362017.0327.03
531204-312046.0626.06
625386-253864.9314.93
10min161869-6186912.01810.677.8512.0210.677.86
255780-5578010.83610.84
350588-505889.8279.83
457430-5743011.15611.16
552417-5241710.18210.18
651389-513899.9839.98
15min171354-7135413.86112.806.5213.8612.806.53
266668-6666812.95112.95
361780-6178012.00112.00
470630-7063013.72013.72
562412-6241212.12412.12
662664-6266412.17312.17
20min176377-7637714.83714.034.6614.8414.034.67
272824-7282414.14714.15
368754-6875413.35613.36
475913-7591314.74714.75
569510-6951013.50313.50
669821-6982113.56313.56
30min181238-8123815.78115.252.4915.7815.252.50
278448-7844815.23915.24
376802-7680214.91914.92
480569-8056915.65115.65
576774-7677414.91414.91
677288-7728815.01415.01
45min184059-8405916.32916.041.8916.3316.041.90
282138-8213815.95615.96
381887-8188715.90715.91
484863-8486316.48516.49
581296-8129615.79215.79
681031-8103115.74115.74
极限188205-8820517.13416.851.1417.1316.841.14
286435-8643516.79116.79
386803-8680316.86216.86
487334-8733416.96516.97
585348-8534816.57916.58
686198-8619816.74516.74
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 12.385085405075345082865085505096275085070.15
212.445119855112155116000.11
单位质量响应值RSD%判断
41074.8841125.400.09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%
5min145552-455528.8607.5812.138.867.5812.11
233809-338096.5766.58
340089-400897.7987.80
433248-332486.4676.47
539344-393447.6537.65
641715-417158.1148.11
10min165035-6503512.65011.716.6712.6511.706.66
258938-5893811.46411.46
363360-6336012.32412.32
453453-5345310.39710.40
560197-6019711.70911.71
660098-6009811.69011.69
15min173751-7375114.34513.624.8214.3513.634.82
268787-6878713.38013.38
373042-7304214.20714.21
464347-6434712.51612.52
570383-7038313.69013.69
669967-6996713.60913.61
20min178365-7836515.24314.633.6115.2414.633.61
274087-7408714.41114.41
376929-7692914.96314.96
470541-7054113.72113.72
575243-7524314.63614.64
676119-7611914.80614.81
30min182614-8261416.06915.722.0716.0715.722.07
279905-7990515.54215.54
382261-8226116.00116.00
478050-7805015.18215.18
580869-8086915.73015.73
681081-8108115.77115.77
45min185068-8506816.54716.391.4316.5516.391.43
283901-8390116.32016.32
385445-8544516.62016.62
482048-8204815.95915.96
584529-8452916.44216.44
684527-8452716.44116.44
极限188783-8878317.26916.981.3417.2716.981.35
286934-8693416.91016.91
388365-8836517.18817.19
485495-8549516.63016.63
586997-8699716.92216.92
687282-8728216.97716.98
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