沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.522804862808352804572806152803522805490.07
227.442817402818772818080.04
单位质量响应值RSD%判断
10194.3710269.970.53数据可信
长期24月-供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121132130732142732136750.8751.001.7750.05%～51.94%
232704432718532711451.78
332619632609132614451.62
431392331391431391849.69
532735632748232741951.83
631692431721731707050.19
2024030221132314332326232320251.1651.561.7050.64%～52.48%
233468633446133457452.96
332331332364332347851.20
432665732656432661051.70
532824732820832822851.95
631830631809431820050.37
2024030321130271230257730264447.9050.202.3348.97%～51.43%
232051832046832049350.73
332346432354332350451.21
431964231956431960350.59
531777931793331785650.31
631876231876131876250.46
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.524862114865224859574863534862384862560.05
227.444867524866764867140.02
单位质量响应值RSD%判断
17669.1917737.390.28数据可信
长期24月-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121155418355424155421247.9048.101.8547.17%～49.03%
256618656665256641948.96
356239256288056263648.63
454181854199054190446.84
556628356602556615448.94
654747454783354765447.34
2024030221155658355635355646848.1048.541.8347.61%～49.46%
257800257764757782449.94
355649955712655681248.13
456269956267156268548.64
556695756722556709149.02
654853754781554817647.38
2024030321152033752039152036444.9847.152.3645.98%～48.32%
254993454944854969147.51
355807255761055784148.22
454849854833954841847.40
554715754777454746647.32
654918654914954916847.47
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.525676705678085676735675725674115676270.03
227.445673555675715674630.03
单位质量响应值RSD%判断
20625.9820680.140.19数据可信
长期24月-供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121163453963429863441849.7547.104.7244.77%～49.43%
258591658598258594945.95
360140460115160127847.15
462750362793762772049.23
555660655728055694343.68
659662459765159713846.83
2024030221160149660077860113747.1447.634.2245.52%～49.74%
264257264248264252750.39
360216860254460235647.24
460658460689660674047.58
556653656661256657444.43
662481462507662494549.01
2024030321160278260254960266647.2647.894.0645.85%～49.93%
261036961013761025347.86
362697762765562731649.19
463945163992963969050.16
556782156746856764444.51
661664661649561657048.35
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.529805379805049807509807059803439805680.02
227.449818549825559822040.06
单位质量响应值RSD%判断
35631.1035794.610.33数据可信
长期24月-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121110940411094049109404546.8844.314.8542.06%～46.56%
210063201006621100647043.12
310362941035840103606744.39
410819081082533108222046.37
595744095821595782841.04
610275891029266102842844.06
2024030221110340731032391103323244.2744.814.3642.76%～46.86%
211090451108453110874947.51
310362891036859103657444.41
410450721046044104555844.80
597377897416397397041.73
610766071077645107712646.15
2024030321110365261035680103610344.3945.124.3043.08%～47.15%
210526931052762105272845.11
310821401082806108247346.38
411061611107008110658447.41
597495497505197500241.78
610649191065416106516845.64
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.521142881114316111428551143282114248411429330.03
227.441145210114594511455780.05
单位质量响应值RSD%判断
41531.0041748.470.37数据可信
长期24月-供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121110777541076984107736941.9147.737.7543.85%～51.62%
211582671157565115791645.04
313158131314884131534851.16
413097831308835130930950.93
512853331285518128542650.00
612202991215161121773047.36
2024030221113142131316544131537851.1649.335.5046.49%～52.17%
212825291283282128290649.90
312864871284293128539050.00
412847221284887128480449.97
513120541311670131186251.03
611289681129168112906843.92
2024030321111530081151823115241644.8245.947.3742.39%～49.49%
210973821098402109789242.70
311202621120120112019143.57
412957551296348129605250.41
511358741133406113464044.13
612872471284778128601250.02
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.521976256197794919781831978152197785419776790.05
227.441974657197695019758040.09
单位质量响应值RSD%判断
71863.3472004.520.14数据可信
长期24月-供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121118519021850402185115239.3845.037.9541.27%～48.78%
219959181994306199511242.44
322704942269473226998448.29
422642932263081226368748.15
522204842220499222049247.23
621038742096643210025844.68
2024030221122733992276340227487048.3946.605.6543.84%～49.36%
222156812216752221621647.14
322236122220515222206447.27
422194402219856221964847.22
522685792268014226829648.25
619440911943797194394441.35
2024030321119849401984265198460242.2243.357.6039.89%～46.80%
218885141889897188920640.19
319289021928943192892241.03
422412612242575224191847.69
519591241955864195749441.64
622264292222778222460447.32
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