Overview
Fluconazole EP Impurity E is a specified impurity in fluconazole drug substances and products as per European Pharmacopoeia (EP) standards. It is structurally related to fluconazole, a triazole antifungal agent used to treat candidiasis and cryptococcal meningitis. This impurity is monitored during manufacturing to ensure the final product meets stringent quality requirements. Regulatory bodies like the EMA and FDA set strict limits for such impurities (typically <0.15% w/w). Pharmaceutical companies use certified reference materials of Fluconazole EP Impurity E for method validation and routine quality control testing, particularly in HPLC and LC-MS analyses.
Physical and Chemical Properties
While exact structural details may vary, Fluconazole EP Impurity E shares the core triazole moiety of fluconazole with potential modifications in side chains. It exhibits moderate polarity, making it separable by reversed-phase HPLC with UV detection at 210-260 nm. The impurity demonstrates stability under recommended storage conditions but may degrade upon prolonged exposure to heat or humidity. Its solubility profile necessitates the use of solvents like methanol or acetonitrile for analytical preparation. Spectroscopic data (IR, NMR) are typically included in high-quality reference standards for identity confirmation.
Main Applications
The primary use of Fluconazole EP Impurity E is as a chromatographic reference standard in pharmaceutical analysis. QC laboratories employ it for: 1) System suitability testing of HPLC methods, 2) Quantifying impurity levels in fluconazole batches, and 3) Method validation per ICH Q2(R1) guidelines. In process chemistry, identifying this impurity helps optimize synthesis routes to minimize its formation. Some manufacturers also use it for forced degradation studies to evaluate method specificity. Regulatory submissions require impurity profiling data where this compound serves as a marker for process consistency.
Safety and Storage
As a pharmaceutical impurity, Fluconazole EP Impurity E should be handled with standard laboratory precautions. Use PPE including nitrile gloves and safety goggles when weighing powder. Avoid generating dust aerosols—work in a fume hood when handling bulk quantities. For long-term stability, store sealed vials under refrigerated conditions (2-8°C) with desiccant. Allow containers to equilibrate to room temperature before opening to prevent moisture absorption. Discard any material showing discoloration or clumping. Suppliers typically provide stability data in the Certificate of Analysis.
B2B Procurement Guide
When sourcing Fluconazole EP Impurity E, prioritize suppliers with ISO 17025 accreditation for reference materials. Key procurement criteria include: batch-specific CoA with purity by HPLC-UV, chromatograms, and residual solvent data. For GMP use, ensure the supplier can provide full regulatory support documentation (DMF, CEP). Pricing depends on quantity and certification level—research-grade material costs approximately $50/mg, while certified GMP standards may exceed $200/mg. Consider lead times (often 4-8 weeks for custom certifications) and minimum order quantities. Some vendors offer pre-weighed ampoules to minimize handling errors.
Related Manufacturers
- 主营：乙醛酸、铁甲酸、二甲基、氟康唑EP杂质E、羟乙基、草酰胺、3-氯丙炔、邻苯二甲、苯甲酰胺、溴氯海因、3-氯水扬酸、磷酸三甲酯、2-羟基喹喔啉、2-苯并唑啉酮、对羟基苯海因、3-环戊二羧酸、6-二氯异烟酸、2-氨基-5-氯苯酚
- 主营：硼酸酐、阻聚剂、己二酸、氟康唑杂质16、氯化锂、发泡剂、乙二醇、醋酸铜、硅酸钠、正癸醇、新癸酸、环烷油、腰果酚、十二醇、酒石酸、碳酸锂、三甘醇、油菜酸、二甘醇、碳酸钾、甲酸钠、硅酸镁、棕榈油、6-氯嘌呤、微晶石蜡、磷酸一铵
- 主营：环丁酮、辛二酸、四甲基哌、氟嘧啶、2-氰基溴苄、透明色液体、啶氮氧化物、类白色粉末、农用杀菌剂、医药中间体、4-溴丁酸甲酯、哌啶醇氧化物、对硝基苯甲酸、4-溴丁酸叔丁酯、对氨基苯甲酰胺
- 主营：植物醇、植物提取物、8-二氨基萘、4-辛氧基二苯碘六氟、4-萘二甲酸、8-氨基喹哪啶、聚二羟基吲哚、2-巯基噻唑啉、6-二羟基吲哚氢、磷钼酸、石胆酸、乙烯基膦酸、劳伦酸、二水合钼酸钠、麦角硫因、DL-樟脑醌、羟乙基磺酸、钼酸、甲基丙烯酸氧杂环丁烷、三羟甲基氨基甲烷盐酸、4-羟乙基哌嗪乙磺酸、5-甲基 N-乙烯基、腺苷、L-谷氨酸-5-叔丁、聚季铵盐-55
- 主营：肉桂醛、肉桂酸、汉防己甲素、氟康唑、阻燃剂、褪黑素、甘氨酸、增塑剂
- 主营：磺酰胺、氧化铌、除醛剂、氟康唑、硅化镱、基硅油、成核剂、酞菁钴、甘氨酸铬、光学树脂、鼠李糖脂、甲磺酸铋、氧化亚铁、封端硅油、左旋乳酸)、六水氯化钇、己基磺酸盐、恩诺沙星钠、二聚季戊四醇、聚醚硫酸酯钠、恶唑啉交联剂、洗手凝胶增稠剂、生物活性玻璃粉、氰基丙烯酸乙酯、脱硫脱氢催化剂
- 主营：叶面肥、钙镁磷肥、工业尿素、氟康唑中间体、发酵赤砂糖、全水溶肥料、洗涤剂添加剂
- 主营：氟康唑、N-二甲基烯丙基、氯化偏苯三酸酐
- 主营：氟康唑中间体、氨基丁酸、漆酶、维生素
- 主营：硫化剂、阻燃剂、甘氨酸、氟康唑杂质7、卡必醇、肉桂醇、碳酸镁、芹菜酮、视黄醇、壬二炔、赖氨酸、藏花醛、甘羟铝、化合物、浮选剂、稀释剂、酸性红、羟乙基、芳叶油、庚二酸、庚二酮、十八烷、碳酸锌、三甲酚、碳酸锶、芹菜素
- 主营：砷酸锂、白云石、水合物、六氟磷酸盐、氮化锌、144205-68-5、二叔丁基、利多卡因、碳化钨钴、泛影葡胺、化合物库、1093222-27-5、羟基苯基、八钼酸铵、生化试剂、苯甲酸乙酯、熊去氧胆酸、胆酸二水合、乙酰丙酮锌、湿法云母粉、干法云母粉、苯碳酸甲酯、脱氧胆酸二水、氨基二琥珀酸、对乙酰氨基苯酚
- 主营：对照品、科研实验、试剂盒、氟沙康唑、多糖、安石榴苷、儿茶素、绿原酸、尿石素、人参皂苷、花青素、维生素、异鼠李素、甘草系列、人参系列、补骨脂系列、雷公藤系列、黄芩系列、柴胡系列、丹参系列、酸枣仁系列、重楼系列、大黄系列、五味子系列、化合物、黄芪皂苷系列
- 主营：苯甲醛、酰亚胺、苯磺酸、氟嘧啶、异丙基、cas-50-63-5、氨基丙基、试剂医药、化学醋酸、化学试剂、甲基硅基、盐酸羟胺、苯并三唑、苄基丙酮、试剂化工、丙烯酰氯、甲基乙炔、氮杂苯并、二叔丁酯、磷酸二苯酯、化学碳酸钾、二酸二乙酯、酸二异丙酯、二咪唑羰基、中间体化工、医药中间体
- 主营：盐酸多奈、多非利特、乙醇酸东、艾氟康唑、盐酸阿考、吡啶甲酸、芜地溴铵、基乙醇酸、羟基苯甲醛、溴铵一水合、吡咯烷系列
- 主营：催化剂、胆酸、氧化剂、氟嘧啶、酶类、光引发剂、生物缓冲剂、交联剂、光敏剂、樟脑醌、十二氢十二硼双钠盐、磷钼酸、钼酸钾、6-二羟基吲哚、6-羟基吲哚、荧光增白剂、葡甲胺、N-乙基哌嗪、L-脯氨酸、鹅去氧胆酸、石胆酸