常见问题
三氯苯达唑检测需要多长时间?
通常7-15个工作日,具体周期根据检测项目数量和样品类型确定,复杂项目如稳定性试验可能需要更长时间。
三氯苯达唑检测费用大概多少?
根据检测项目数量确定,常规单项检测如含量测定费用较低,涉及全套杂质谱分析和稳定性试验时费用相应增加。
三氯苯达唑检测报告有什么用途?
可用于质量评估、项目验收、药典符合性验证、产品注册申报及进出口贸易检验,中析检测中心旗下实验室拥有CMA、CNAS、ISO等检验检测资质,报告具备法定效力。
三氯苯达唑检测对样品有什么要求?
原料药需提供不少于5g的样品量,制剂需提供完整包装不少于20个很小单元,样品应避光密封保存并在运输过程中防止高温和潮湿。
检测范围
- 三氯苯达唑原料药
- 三氯苯达唑原粉
- 三氯苯达唑口服悬液
- 三氯苯达唑片剂
- 三氯苯达唑胶囊
- 三氯苯达唑预混剂
- 三氯苯达唑可溶性粉
- 三氯苯达唑注射液
- 三氯苯达唑混悬液
- 三氯苯达唑颗粒剂
- 三氯苯达唑散剂
- 三氯苯达唑微囊制剂
- 三氯苯达唑缓释制剂
- 三氯苯达唑肠溶制剂
- 三氯苯达唑兽用制剂
- 三氯苯达唑人用制剂
- 三氯苯达唑中间体
- 三氯苯达唑对照品
- 三氯苯达唑标准品
- 三氯苯达唑代谢产物
- 三氯苯达唑残留物
- 三氯苯达唑类似物
- 三氯苯达唑衍生物
检测标准(部分)
- 32014R0676 Commission Implementing Regulation (EU) No 676/2014 of 19 June 2014 amending Regulation (EU) No 37/2010, as regards the substance ‘triclabendazole’ Text with EEA relevance
- 32012R0222 Commission Implementing Regulation (EU) No 222/2012 of 14 March 2012 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance triclabendazole Text with EEA relevance
- 32010R0893 Commission Regulation (EU) No 893/2010 of 8 October 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acequinocyl, bentazone, carbendazim, cyfluthrin, fenamidone, fenazaquin, flonicamid, flutriafol, imidacloprid, ioxynil, metconazole, prothioconazole, tebufenozide and thiophanate-methyl in or on certain products Text with EEA relevance
- 32006R1729 Commission Regulation (EC) No 1729/2006 of 23 November 2006 amending Annexes I and III to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards firocoxib and triclabendazole (Text with EEA relevance)
- 32006R1729R(01) 1729/2006/KE: Rettifika għar-Regolament tal-Kummissjoni (KE) Nru 1729/2006 tat- 23 ta' Novembru 2006 li jemenda l-Annessi I u III tar-Regolament tal-Kunsill (KEE) Nru 2377/90 li jistabbilixxi proċedura tal-Komunità għall-iffissar ta’ limiti massimi ta’ residwi ta’ prodotti mediċinali veterinarji fi prodotti tal-ikel ta’ oriġini mill-annimali, fir-rigward tal-firocoxib u triclabendazole ( Il-Ġurnal Uffiċjali tal-Unjoni Ewropea L 338 M, tal-17 ta'
- 32012R0899 Commission Regulation (EU) No 899/2012 of 21 September 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acephate, alachlor, anilazine, azocyclotin, benfuracarb, butylate, captafol, carbaryl, carbofuran, carbosulfan, chlorfenapyr, chlorthal-dimethyl, chlorthiamid, cyhexatin, diazinon, dichlobenil, dicofol, dimethipin, diniconazole, disulfoton, fenitr
- 32012R0270 Commission Regulation (EU) No 270/2012 of 26 March 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for amidosulfuron, azoxystrobin, bentazone, bixafen, cyproconazole, fluopyram, imazapic, malathion, propiconazole and spinosad in or on certain products Text with EEA relevance
- 32007L0027R(01) Corrigendum to Commission Directive 2007/27/EC of 15 May 2007 amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for etoxazole, indoxacarb, mesosulfuron, 1-methylcyclopropene, MCPA and MCPB, tolyfluanid and triticonazole ( OJ L 128, 16.5.2007 )
- 32008L0125 Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (Text with EEA relevance)
- 32014R0398 Commission Regulation (EU) No 398/2014 of 22 April 2014 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benthiavalicarb, cyazofamid, cyhalofop-butyl, forchlorfenuron, pymetrozine and silthiofam in or on certain products Text with EEA relevance
- 32009L0146 Commission Directive 2009/146/EC of 26 November 2009 correcting Directive 2008/125/EC amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (Text with EEA relevance)
- 32006R1055 Commission Regulation (EC) No 1055/2006 of 12 July 2006 amending Annexes I and III to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards flubendazole and lasalocid (Text with EEA relevance)
- 32012R0899R(02) Ispravak Uredbe Komisije (EU) br. 899/2012 od 21. rujna 2012. o izmjeni priloga II. i III. Uredbi (EZ) br. 396/2005 Europskog parlamenta i Vijeća o maksimalnim razinama ostataka acefata, alaklora, anilazina, azociklotina, benfurakarba, butilata, kaptafola, karbarila, karbofurana, karbosulfana, klorfenapira, klortal-dimetila, klortiamida, ciheksatina, dijazinona, diklorbenila, dikofola, dimetipina, dinikonazola, disulfotona, fenitrotiona, flufenzi
检测项目
- 含量测定:通过HPLC法测定三氯苯达唑有效成分含量,确保制剂标示量在90.0%-110.0%范围内
- 有关物质:检测三氯苯达唑中的降解产物和合成杂质,单杂不得超过0.5%,总杂不得超过1.0%
- 溶出度:评估三氯苯达唑固体制剂在规定介质中的释放速率,45分钟溶出量应不低于标示量的70%
- 水分测定:采用卡尔费休法测定三氯苯达唑原料中水分含量,应不超过0.5%
- 炽灼残渣:检测三氯苯达唑中无机杂质残留量,限度为0.1%
- 重金属:检测三氯苯达唑中铅、镉、砷等重金属含量,限度不超过20ppm
- 残留溶剂:检测三氯苯达唑合成过程中使用的有机溶剂残留,应符合ICH Q3C限度要求
- 熔点测定:通过毛细管法测定三氯苯达唑熔点,应在规定范围内用于鉴别和纯度判断
- 干燥失重:检测三氯苯达唑在105℃干燥至恒重的减失重量,应不超过0.5%
- 粒度分布:测定三氯苯达唑粉末的粒径分布,D90应不超过50μm以确保制剂均匀性
- 堆密度:测定三氯苯达唑原料粉体的松密度和振实密度,评估其粉体学特性
- pH值:测定三氯苯达唑溶液或混悬剂的酸碱度,应在规定范围内
- 旋光度:测定三氯苯达唑的比旋度,用于鉴别光学纯度
- 紫外吸收:通过紫外分光光度法测定三氯苯达唑特征吸收波长,用于定性鉴别
- 红外光谱:通过IR光谱比对三氯苯达唑官能团特征峰,用于结构确证
- 质谱分析:通过LC-MS/MS测定三氯苯达唑分子量和碎片离子,用于结构确认和痕量检测
- 晶型分析:通过X射线衍射法测定三氯苯达唑晶型,确保多晶型一致性
- 微生物限度:检测三氯苯达唑制剂中需氧菌、霉菌及酵母菌总数,应符合药典规定
- 无菌检查:对三氯苯达唑注射液进行无菌检测,确保无微生物污染
- 细菌内毒素:检测三氯苯达唑注射剂中内毒素含量,应低于规定阈值
- 稳定性试验:通过加速试验和长期试验考察三氯苯达唑在不同条件下的降解趋势
- 含量均匀度:检测三氯苯达唑片剂或胶囊含量均匀度,A+2.8S应不大于15.0
检测信息
三氯苯达唑是一种苯并咪唑类广谱抗寄生虫药物,主要用于肝片形吸虫感染,广泛应用于兽药制剂及人用抗寄生虫药物领域。
检测目的在于确认三氯苯达唑原料药及制剂中有效成分含量、杂质水平及理化性质是否符合药典标准,涉及高效液相色谱法、紫外分光光度法、质谱法等技术手段。
检测流程包括样品前处理、色谱分离、定量分析和数据报告等环节,核心参数涵盖含量测定、有关物质、残留溶剂、熔点、干燥失重等指标。
总结
三氯苯达唑检测覆盖原料药及各类制剂的含量测定、有关物质、残留溶剂等核心指标。中析检测中心旗下实验室拥有CMA、CNAS、ISO等检验检测资质。检测周期通常7-15个工作日,报告可用于质量评估与项目验收。
相关检测
检测服务常见问题
检测报告多久可以出具?
检测报告一般7~15个工作日出具,支持加急服务,具体周期与检测项目相关。
如何获取这个项目的检测报价?
可点击页面在线咨询,说明样品与检测需求后即可获取检测项目与报价建议。
样品如何送检?
支持寄样检测与上门取样两种方式,样品保存与寄送要求可在咨询时获取指引。











