叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.447477475715755037555975524754150.49
217.397603976012760260.03
单位质量响应值RSD%判断
4324.254371.820.78数据可信
影响因素5天-供试品溶液-叶酸-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批174578739047424186.2583.522.2881.52%~85.51%
271673711847142882.98
370051701587010481.44
473476729057319085.03
570423700777025081.61
672131721457213883.80
2024092121批179843801417999292.9389.854.8185.31%~94.38%
277582775027754290.08
370271700387015481.50
480426802268032693.32
577446774957747090.00
678557785367854691.25
2024092121批174249746087442886.4682.506.6876.72%~88.29%
270985716537131982.85
362541625276253472.65
471193712617122782.75
576324763417633288.68
670420701287027481.64
2024092121批177654776747766490.2288.704.1884.81%~92.60%
277902779727793790.54
370272704087034081.72
477151756317639188.74
579979792307960492.48
676379760267620288.53
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.989783597353970169678197037972040.42
215.959701096538967740.35
单位质量响应值RSD%判断
6082.856067.340.19数据可信
影响因素5天-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批1121246121383121314102.4499.133.3195.69%~102.57%
211663111689911676598.60
3121481121702121592102.68
411319311276011297695.40
511284511289011286895.31
6118745118905118825100.34
2024092121批1121384121755121570102.6699.383.2795.97%~102.78%
211748411721011734799.09
3121812121905121858102.90
411337111335611336495.73
511297811322311310095.51
6118972118734118853100.36
2024092121批1125240124672124956105.5299.803.9095.72%~103.87%
211216711233411225094.79
3119849119404119626101.02
411415911366911391496.19
511894611724711809699.72
6120403120083120243101.54
2024092121批1124211124758124484105.1299.763.7995.79%~103.72%
211150911207211179094.40
3119650119387119518100.92
411441611432411437096.58
5119012118383118698100.23
6119081120787119934101.28
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.447708876932766477671977174769120.30
217.397646976164763160.29
单位质量响应值RSD%判断
4410.094388.500.35数据可信
影响因素10天-供试品溶液-叶酸-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批168344683426834378.4779.1212.5268.73%~89.52%
271039707287088481.39
373041732377313983.97
474803750047490486.00
574120742937420685.20
651994519985199659.70
2024092121批176012757677589087.1392.024.1088.06%~95.98%
277909775777774389.26
384955847048483097.40
480130803568024392.13
582987827268285695.13
679250793837931691.07
2024092121批167094672686718177.1377.179.9769.10%~85.24%
268809687486877878.97
371060709297099481.51
471024712147111981.66
571249712807126481.82
653781541185395061.94
2024092121批178686786257865690.3188.202.8485.58%~90.82%
275053751787511686.24
375612756247561886.82
479136792157917690.91
574078738967398784.95
678491782367836489.97
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.989749197526974919740397684975190.11
215.959794797776978620.13
单位质量响应值RSD%判断
6102.576135.550.39数据可信
影响因素10天-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批111780111723611751898.5298.302.3195.92%~100.67%
211357011409611383395.43
3120020120343120182100.76
411843711810911827399.16
5119626119474119550100.23
611413611415011414395.69
2024092121批111741211719711730498.3498.032.2495.73%~100.33%
211371911348811360495.24
3119804119867119836100.47
411774911760111767598.66
511913311924211918899.92
611387011404211395695.54
2024092121批111813211828711821099.1098.243.1694.98%~101.50%
211668111701411684897.96
311029611001211015492.35
411912011902211907199.83
5120996120822120909101.37
611779711793511786698.82
2024092121批111830611815311823099.1297.963.0594.83%~101.08%
211644911635111640097.59
311002310999411000892.23
411909111894811902099.78
5119727120019119873100.50
611754811744811749898.51
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.447419973695740567387774457740570.40
217.397472174613746670.11
单位质量响应值RSD%判断
4246.394293.670.79数据可信
影响因素5天-供试品溶液-叶酸-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批168459687006858081.1378.862.8576.51%~81.22%
266558672266689279.13
367761683506805680.51
467381676596752079.87
565597653726548477.46
663667632946348075.09
2024092121批176746769517684890.9191.022.8288.33%~93.70%
279595795367956694.12
379648793807951494.06
474693745977464588.30
576493757537612390.05
673736761847496088.67
2024092121批167373674096739179.7278.843.8375.67%~82.01%
266456661676631278.44
369448697056957682.30
462438617456209273.45
566364662376630078.43
668099683196820980.69
2024092121批178192782637822892.5489.952.7387.37%~92.52%
276537765177652790.53
378472778527816292.46
471676739177279686.11
575170747357495288.66
675465756477555689.38
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.989727097376971539736097070972460.14
215.959749797737976170.18
单位质量响应值RSD%判断
6085.486120.190.41数据可信
影响因素5天-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批111576211537611556997.1599.322.8896.32%~102.32%
211834511811611823099.38
311450811467011458996.32
4124390124006124198104.40
511725411720811723198.54
6119152119139119146100.15
2024092121批111589111590111589697.4299.702.7096.88%~102.52%
211891511887011889299.94
311518111513911516096.80
4124029124334124182104.39
511815111825311820299.36
6119280119296119288100.27
2024092121批111030711020611025692.6895.942.2693.67%~98.21%
211541711550911546397.06
311703011694911699098.34
411299811271011285494.87
511289711283911286894.88
611637211633111635297.81
2024092121批111119211122311120893.4896.952.2094.71%~99.19%
211638011660711649497.92
311874411884711879699.86
411440611461211450996.26
511465911488811477496.48
611632011612611622397.70
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.447402073804741087391273498738680.33
217.397498375170750760.18
单位质量响应值RSD%判断
4235.554317.191.35数据可信
影响因素10天-供试品溶液-叶酸-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批160874611116099272.0568.234.4765.03%~71.43%
260551609206073671.74
355048548325494064.90
455276555635542065.47
557079570935708667.43
657408573305736967.77
2024092121批178942772597810092.2688.454.3384.44%~92.46%
272268725547241185.54
371138710177107883.96
473773731167344486.76
579466790947928093.65
675009748677493888.52
2024092121批168507705776954282.1581.861.7180.40%~83.32%
270317705597043883.21
367274667596701679.16
469399695086945482.04
569874698086984182.50
669593694366951482.11
2024092121批175244749767511088.7292.883.2889.69%~96.07%
278897811798003894.55
375750760007587589.63
478951790607900693.33
581509815718154096.32
680484799298020694.74
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.989820197693981449820997918980330.23
215.959747997695975870.16
单位质量响应值RSD%判断
6134.736118.310.19数据可信
影响因素10天-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批1119844119794119819100.3399.862.9996.73%~102.99%
2121464121443121454101.70
311913611914911914299.76
4119830120055119942100.43
511236611258911247894.18
6122675122746122710102.75
2024092121批111938611928511933699.93100.142.7397.28%~103.00%
2122153122187122170102.30
3119929119676119802100.32
4120562120383120472100.88
511346411341211343894.99
6122300122372122336102.44
2024092121批111764711768111766498.5396.952.2094.71%~99.18%
211767811712711740298.31
311243111252011247694.18
411645811631611638797.46
511265611269911267894.35
611793311819911806698.86
2024092121批111783711812011797898.7997.522.1995.28%~99.75%
211814811792311803698.84
311310811303511307294.68
411770811753211762098.49
511331511338711335194.91
611883411856811870199.39
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