检测项目
- 含量测定：判定芬苯达唑有效成分是否符合标示量要求，确保。
- 有关物质：检测合成工艺残留的杂质及降解产物，控制药物纯度与毒副作用。
- 干燥失重：评估原料或制剂中水分及挥发性物质的含量，防止影响稳定性。
- 炽灼残渣：检测无机杂质残留量，评判原料药生产过程中的洁净度。
- 重金属：限定铅、镉等有害重金属含量，保障用药安全。
- 砷盐：检测有害元素砷的残留量，避免引发动物毒性反应。
- 熔点：验证芬苯达唑原料药的理化性质及晶型纯度。
- 晶型：判定药物多晶型形态，直接影响药物的溶解度与生物利用度。
- 溶出度：评估片剂或颗粒剂在规定介质中的释放速度，反映体内吸收情况。
- 脆碎度：检查片剂在运输和贮存过程中抗磨损的能力，保证外观完整。
- 崩解时限：测定固体制剂在规定液体中崩散的时间，影响药物起效速度。
- 粒度：分析粉剂或预混剂的颗粒大小分布，影响混合均匀度与。
- 沉降体积比：评估混悬型制剂的物理稳定性，防止分层影响给药剂量。
- 残留溶剂：检测合成过程中使用的有机溶剂残留量，控制潜在毒性风险。
- pH值：测定液体制剂的酸碱度，确保符合给药途径的生理耐受性。
- 澄明度：检查注射液或溶液剂的澄清程度，排查不溶性微粒污染。
- 无菌：验证注射用芬苯达唑制剂中是否含有微生物，确保无感染风险。
- 细菌内毒素：检测注射液中的内毒素限量，防止引发动物发热反应。
- 装量差异：检查单剂量包装的重量均匀度，保证每袋或每支药物剂量准确。
- 均匀度：验证粉末或颗粒中主药分布的均匀性，防止局部浓度过高或过低。
检测信息
芬苯达唑是一种广谱苯并咪唑类驱虫药，主要用于防治畜禽线虫、绦虫及吸虫等寄生虫感染，广泛应用于兽药原料药及各类兽药制剂的生产与应用领域。
检测目的在于确认有效成分含量及杂质水平，保障兽药疗效与安全性，涉及高效液相色谱法、紫外分光光度法等核心技术手段进行定量与定性分析。
核心检测参数涵盖含量测定、有关物质检查、干燥失重及残留溶剂分析，整个流程严格遵循兽药国家标准及药典规范进行样品前处理与仪器分析。
常见问题
芬苯达唑检测需要多长时间？
芬苯达唑检测通常需要7-15个工作日，具体时间视检测项目数量及样品复杂程度而定。
芬苯达唑检测费用大概多少？
芬苯达唑检测费用根据检测项目数量确定，不同剂型和检测指标组合对应不同报价，可提供详细清单。
芬苯达唑检测需要提供多少样品量？
原料药通常需提供不少于10克，制剂需提供不少于10个很小包装单位，以满足含量测定及复测需求。
检测范围
- 芬苯达唑原料药
- 芬苯达唑粉
- 芬苯达唑片
- 芬苯达唑预混剂
- 芬苯达唑颗粒
- 芬苯达唑混悬液
- 芬苯达唑可溶性粉
- 芬苯达唑注射液
- 芬苯达唑透皮溶液
- 芬苯达唑丸剂
- 芬苯达唑微囊
- 芬苯达唑微乳
- 复方芬苯达唑粉
- 复方芬苯达唑片
- 阿苯达唑芬苯达唑混悬液
- 芬苯达唑伊维菌素预混剂
- 芬苯达唑多拉菌素片
- 宠物用芬苯达唑咀嚼片
- 水产用芬苯达唑药饵
- 畜禽用芬苯达唑浇泼剂
- 芬苯达唑散剂
- 芬苯达唑缓释制剂
检测标准（部分）
- GB/T 22972-2008 牛奶和奶粉中噻苯达唑、阿苯达唑、芬苯达唑、奥芬达唑、苯硫氨酯残留量的测定 液相色谱-串联质谱法
- DB35/T 884-2009 鳗鲡肌肉中阿苯达唑、阿苯达唑亚砜和阿苯达唑砜残留量的测定 高效液相色谱法
- SN/T 0684-2011 出口肉及肉制品中奥芬哒唑、芬苯哒唑、苯硫胍及奥芬哒唑砜残留量检测方法 液相色谱-质谱/质谱法
- 32017R0841 Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flumioxazine, foram
- GB 29687-2013 食品安全国家标准 水产品中阿苯达唑及其代谢物多残留的测定 高效液相色谱法
- GB 31658.11-2021 食品安全国家标准 动物性食品中阿苯达唑及其代谢物残留量的测定 高效液相色谱法
- SN 0684-1997 出口肉及肉制品中奥芬达唑残留量检验方法
- 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
- 32012R1161 Commission Implementing Regulation (EU) No 1161/2012 of 7 December 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 fenbendazole Text with EEA relevance
- 农业部1163号公告-4-2009 动物性食品中阿苯达唑及其标示物残留检测 高效液相色谱法
- 32017R0841R(01) Corrigendum to Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 (flupyrsulfuron-methyl), etoxazole, famoxadone, fenamidone, flum
- 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
- 农业部958号公告-9-2007 动物可食性组织中阿苯达唑及其主要代谢物残留检测方法 高效液相色谱法
- 32018R0917 Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumi
- 32012R0441 Commission Regulation (EU) No 441/2012 of 24 May 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 bifenazate, bifenthrin, boscalid, cadusafos, chlorantraniliprole, chlorothalonil, clothianidin, cyproconazole, deltamethrin, dicamba, difenoconazole, dinocap, etoxazole, fenpyroximate, flubendiamide, fludioxonil, glyphosate, metalaxyl-M, meptyldinocap
- 32013R0834 Commission Regulation (EU) No 834/2013 of 30 August 2013 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, bixafen, diazinon, difenoconazole, etoxazole, fenhexamid, fludioxonil, isopyrazam, lambda-cyhalothrin, profenofos and prothioconazole in or on certain products Text with EEA relevance
- BBl 2020 6057 Allgemeinverfügung betreffend die Streichung von Pflanzenschutzmitteln mit den Wirkstoffen Chlorpropham (CIPC), Difenoconazol, Diquat, Fenpropidin, Methomyl und Phenmedipham aus der Liste der nicht bewilligungspflichtigen Pflanzenschutzmittel
- 32018R1796 Commission Implementing Regulation (EU) 2018/1796 of 20 November 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin
- 32011R0978 Commission Regulation (EU) No 978/2011 of 3 October 2011 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 acetamiprid, biphenyl, captan, chlorantraniliprole, cyflufenamid, cymoxanil, dichlorprop-P, difenoconazole, dimethomorph, dithiocarbamates, epoxiconazole, ethephon, flutriafol, fluxapyroxad, isopyrazam, propamocarb, pyraclostrobin, pyrimethanil and s
- 32011R0520 Commission Regulation (EU) No 520/2011 of 25 May 2011 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 benalaxyl, boscalid, buprofezin, carbofuran, carbosulfan, cypermethrin, fluopicolide, hexythiazox, indoxacarb, metaflumizone, methoxyfenozide, paraquat, prochloraz, spirodiclofen, prothioconazole and zoxamide in or on certain products Text with EEA rel
总结
芬苯达唑检测覆盖原料药及制剂的含量、杂质及理化指标。