Drug Monographs and Assays using Ion Chromatography

现代方法，与时俱进

2011年，美国药典(USP) 对国际制药行业进行了一项调查，旨在评估用于成盐药物中的离子和对离子鉴别的检测方法。当发现分光光度法是最普遍的方法后，USP发起了一项倡议，对所有药典正文中的已有方法进行更新。受访者倾向于仪器方法检测，而非传统湿化学检测，并对程序说明和验收标准感兴趣。除满足这些需求外，药典正文方法的提高还有助于与其他药典保持一致，启用更为严格的鉴别方法，以减少药物掺假和伪造行为。

离子色谱法的优势

现有测定方法耗时费力，涉及有害化学品，需对分析人员进行大量培训，并可能出现明显测量误差，离子色谱法 (IC) 凭借以下优势显著改善了这些方法：

  • 速度：在单次进样中同时测定多种阴离子或阳离子。
  • 重现性：通常使用电解生成流动相（即无手动制备流动相），简化方法，提高实验室内和实验室间方法重现性。
  • 准确度：检出限远低于 USP 正文中所设定的限值。
  • 安全性：分析人员无需处理有害试剂，可稳健测量多种分析物。
  • 成本效益：流动相无需昂贵试剂或 pH 值调整。

USP 通则

  • <1065> 离子色谱
  • <191> 鉴别实验 - 通用
  • <345> 柠檬酸/柠檬酸盐和磷酸盐的测定
  • <1225> 药典方法的验证

IC 仪器采用一系列适用于制药行业应用的技术，包括：

  • 模块化 IC 系统，提供丰富的化学键合相、检测器和自动化选项，满足不断增长的应用需求。
  •  集成式 IC 系统，以最低的操作成本实现最佳可靠性。配全面系统监控和简化管路布局，新用户快速上手。

任意系统均配精确的自动流动相生成和样品制备功能，节省时间，提高重现性。

观看白板视频，了解 IC 详情。

Whiteboard video

Learn the basics of ion chromatography, including an introduction to the Dionex Integrion HPIC system.

Whiteboard video

This whiteboard video discusses the role of eluents and eluent generation in separating compounds via ion chromatography.

On demand webinar

In this webcast, we will discuss the role of IC in USP monograph modernization, including the presentation of selected case studies where IC has been successfully adopted for monograph modernization.

精选视频和海报注释

Sachin Patil 建立了使用抑制型电导检测免试剂离子色谱法 (RFIC) 系统测定柠檬酸锂中锂的方法，以此作为现有测定方法的升级候选。

现代化 的IC 测定和应用

No records were found matching your criteria

TypeTitleTestColumnResource #
Brochure Ion Chromatography for Pharma and Biopharma—Various BR72257
Application Note Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a High-Pressure Compact Ion Chromatography SystemAssayIonPac AS11 AU205
Application Note Determination of tobramycin using HPAE-IPAD on a compact ion chromatography systemAssay, impurityCarboPac PA1 AU72197
Application Note Faster and Improved Ease-of-Use Assays of Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography with Suppressed ConductivityAssayIonPac AS11 PN72097
Application Note Determination of Methylamine in Drug ProductsImpurityIonPac CS19 AN1057
Presentation Increasing Importance of Ion Chromatography for Pharmaceutical Analysis—Various—
Application Brief Assay for Citrate and Phosphate in Pharmaceutical Formulations Using a Compact IC SystemAssayIonPac AS11 AB71920
Application Note Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion ChromatographyAssayIonPac AS11 AN71941
Application Brief Assay for Lithium, Sodium, and Calcium in Lithium Carbonate Using a Compact Ion Chromatography SystemAssayIonPac CS16 AB71919
Application Note Assay of Nitrite and Determination of Nitrate Impurity in Sodium Nitrite Using a Reagent-Free Ion Chromatography SystemAssay, impurityIonPac AS12A AN71893
Application Note Determination of Ammonia in Sodium BicarbonateImpurityIonPac CS16 AN70815
Application Brief Determination of Ammonia in Sodium Bicarbonate Using a Compact Ion Chromatography SystemImpurityIonPac CS16 AB71921
Application Note Determination of Benzenesulfonic Acid Counterion in Amlodipine Besylate by Ion ChromatographyCounterionIonPac AS18 AN70907
Application Brief Determination of Inorganic Counterions in Pharmaceutical Drugs Using Capillary ICCounterionIonPac AS19 AB70454
Application Brief Determination of Sulfate and Sulfamate in Topiramate Using a Compact Reagent-Free Ion Chromatography SystemAssayIonPac AS11 AB71934
Poster Note Determination of Sulfate Counter Ion and Anionic Impurities in Aminoglycoside Drug Substances by Ion Chromatography with Suppressed Conductivity DetectionCounterion, impurityIonPac AS18 LPN 2019-01
Application Note Determination of Tartaric Acid in Tolterodine Tartrate Drug Products by IC with Suppressed Conductivity DetectionCounterionIonPac AS20, IonPac AS22 AN1002
Poster Note IC Assay for Lithium in Lithium CitrateAssay, impurityIonPac CS12A PN71825
Poster Video IC Assay for Lithium in Lithium CitrateAssay, impurityIonPac CS12A 
Application Brief IC Assay for Lithium, Sodium, and Calcium in Lithium CarbonateAssay, impurityIonPac CS16 AB71919
Webinar ImpurityVarious 
Application Note Implementation of a Walk-Up High-Pressure Capillary Ion Chromatograph for the Fast Separation of Pharmaceutical Relevant Inorganic Anions and CationsImpurityVarious AN2967
Application Note Ion Chromatography Assay for Lithium in Lithium CitrateAssayIonPac CS12A AN71522
Application Note Ion Chromatography Assay for Lithium in Lithium HydroxideAssay, impurityIonPac CS16 AN71807
Application Note Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion ChromatographyAssayIonPac AS11 AN71941
Smart Note Rapid Analysis of Critical Electrolytes and Impurities in Dialysis SolutionsAssayVarious SN37707
Application Note Determination of Inorganic Anion Impurities in a Water-Insoluble Pharmaceutical by Ion Chromatography with Suppressed Conductivity Detection—— AN220
Application Note Magnesium Oxide Monograph Modernization with Ion Chromatograph—— AN74041
Application Note Determination of fluoride in sodium fluoride oral solution using carbonate/bicarbonate eluentAssayIonPac AS22 AN002344
Application Note Determination of fluoride in sodium fluoride oral solution AssayIonPac AS22 AN002345

No records were found matching your criteria

类型标题检测项目色谱柱离子源编号
应用简介紧凑型 IC 系统测定药物制剂中柠檬酸盐和磷酸盐含量测定IonPac AS11AB71920
应用指南离子色谱法测定药物制剂中柠檬酸盐和磷酸盐含量测定IonPac AS11AN71941
应用简介紧凑型离子色谱系统测定碳酸锂中锂、钠和钙含量测定IonPac CS16AB71919
应用指南免试剂离子色谱系统测定亚硝酸钠中亚硝酸盐和亚硝酸盐杂质杂质测定 IonPac AS12AAN71893
应用指南碳酸氢钠中氨的测定杂质IonPac CS16AN70815
应用简介紧凑型离子色谱系统测定碳酸氢钠中的氨杂质IonPac CS16AB71921
应用指南离子色谱法测定苯磺酸氨氯地平中的苯磺酸对离子对离子IonPac AS18AN70907
应用简介毛细管 IC 测定药品中的无机对离子对离子IonPac AS19AB70454
应用简介紧凑型免试剂离子色谱系统测定托吡酯中的硫酸盐和氨基磺酸含量测定IonPac AS11AB71934
海报注释抑制型电导检测离子色谱法测定氨基糖苷类药物原料中的硫酸盐对离子和阴离子杂质对离子, 杂质IonPac AS18LPN 2019-01
应用指南抑制型电导检测 IC 测定酒石酸托特罗定药物产品中的酒石酸对离子IonPac AS20, IonPac AS22AN1002
海报注释高压毛细管 IC 快速分离过敏药片中的对离子对离子IonSwift MAX-200TN70173
海报注释离子色谱法测定柠檬酸锂中的锂杂质测定IonPac CS12APN71825
视频海报离子色谱法测定柠檬酸锂中的锂杂质测定IonPac CS12A
应用简介IC 测定柠檬酸锂中的锂、钠和钙 杂质测定IonPac CS16AB71919
网络讲座IC 测定药物原料和药物产品中的杂质、降解产物和反离子杂质Various
应用指南Walk-Up 高压毛细管离子色谱法快速分离制药相关无机阴离子和阳离子杂质VariousAN2967
应用指南离子色谱法测定柠檬酸锂中的锂含量测定 IonPac CS12AAN71522
应用指南离子色谱法测定 氢氧化锂中的锂杂质测定IonPac CS16AN71807
应用指南Assay for Citrate and Phosphate in Pharmaceutical Formulations Using Ion Chromatography含量测定IonPac AS11AN71941
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