{"id":1933,"date":"2025-12-03T13:25:31","date_gmt":"2025-12-03T13:25:31","guid":{"rendered":"https:\/\/www.chromacon.com\/?post_type=application&p=1933"},"modified":"2026-05-10T22:22:42","modified_gmt":"2026-05-10T20:22:42","slug":"impurity-isolation","status":"publish","type":"application","link":"https:\/\/www.chromacon.com\/en\/applications\/impurity-isolation\/","title":{"rendered":"Impurity Isolation"},"content":{"rendered":"
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\n TRACE IMPURITIES <\/p>\n \n

\n Isolate What’s Barely There. Trace Impurity<\/strong> Enrichment with N-Rich\u00ae.\n <\/h1>\n \n
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Overnight enrichment of trace impurities for ICH Q3A\/Q6B reference standards, charge variants, glycoforms, and more. Across published cases: 100\u20131,000\u00d7<\/strong> Enrichment factor | 80\u201395%<\/strong> Purity (from <20% by batch) | 10 h<\/strong> vs. 300 h analytical HPLC | 69\u00d7<\/strong> Less solvent<\/p>\n

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Sources: Bigelow et al. <\/em>(BMS), J. Chromatogr. <\/em>A 2021; Weldon & M\u00fcller-Sp\u00e4th, J. Chromatogr. A 2022<\/em><\/p>\n <\/div>\n <\/div>\n\n

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\n Talk to Our Impurity Isolation Specialists <\/span><\/a><\/span> <\/div>\n
\n N-Rich Tutorial Paper<\/span><\/a><\/span> <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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\n Talk to Our Impurity Isolation Specialists <\/span><\/a><\/span> <\/div>\n
\n N-Rich Tutorial Paper<\/span><\/a><\/span> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n
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\n The Impurity Isolation Bottleneck <\/h2>\n \n
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Regulatory agencies require isolated, pure impurity reference standards \u2014 not just detected peaks. ICH Q3A(R2) mandates structural identification above 0.10% and toxicological qualification above 0.15% for certain classes of molecules. ICH Q6B demands comprehensive characterization of all product-related variants for biologics. A common FDA citation deficiency: “failure to provide a sample of a critical impurity.”<\/em><\/p>\n

The problem: trace impurities co-elute with a dominant main peak.<\/strong> Conventional batch preparative HPLC requires hundreds of injections, produces dilute, low-purity fractions, and may take 30+ days per isoform<\/strong>. Custom synthesis costs $5,000\u2013$50,000+ per compound<\/strong> \u2014 and is simply impossible for biologic impurities like charge variants, glycoforms, or aggregates that only exist as product-related species.<\/p>\n <\/div>\n \n <\/div>\n\n

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\n The Solution: N-Rich\u00ae Twin-Column Enrichment Chromatography <\/h2>\n \n
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N-Rich\u00ae is YMC ChromaCon’s automated enrichment process for isolating trace impurities from complex mixtures. Two identical columns cyclically accumulate the target impurity on-column across repeated load\u2013recycle\u2013wash cycles \u2014 progressively depleting the dominant main peak. The result: 100- to 1000-fold enrichment in an overnight run<\/strong> using conventional resin (IEX, HIC, RP-C8).<\/p>\n

ChromIQ\u00ae software’s N-Rich\u00ae Process Wizard configures the entire run from a single batch chromatogram: Once configured, N-Rich\u00ae runs fully unattended.<\/p>\n

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Same resin. Your existing batch conditions are the starting point.<\/strong> N-Rich works with the IEX, RP, HIC, and other standard stationary phases and mobile phases already used in your existing analytical or batch preparative method. The ChromIQ\u00ae N-Rich\u00ae Process Wizard builds the initial enrichment method parameters from a single batch chromatogram \u2014 minimal chromatographic expertise required.<\/p>\n<\/blockquote>\n <\/div>\n \n Learn About N-Rich\u00ae with AutoPeak\u00ae<\/span><\/a><\/span> <\/div>\n\n

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Proven Results: N-Rich\u00ae vs. Conventional Isolation<\/h2>\n\n\n\n
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\n Overnight <\/h2>\n \n

\n Fully Automated Runs
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\n >80\u201395% <\/h2>\n \n

\n Purity Achieved <\/p>\n \n \n <\/div>\n\n<\/div>\n\n <\/div><\/section><\/div>\n\n\n\n

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\n 100\u20131000\u00d7 <\/h2>\n \n

\n Enrichment Factor <\/p>\n \n \n <\/div>\n\n<\/div>\n\n <\/div><\/section><\/div>\n<\/div>\n\n\n\n

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\n 3 days <\/h2>\n \n

\n vs. 30+ Days (Biosimilar mAb) <\/p>\n \n \n <\/div>\n\n<\/div>\n\n <\/div><\/section><\/div>\n\n\n\n

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\n >50\u00d7 <\/h2>\n \n

\n Productivity Gain (Peptide) <\/p>\n \n \n <\/div>\n\n<\/div>\n\n <\/div><\/section><\/div>\n\n\n\n

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\n >10\u00d7 <\/h2>\n \n

\n Faster than Batch (mAb BMS) <\/p>\n \n \n <\/div>\n\n<\/div>\n\n <\/div><\/section><\/div>\n<\/div>\n\n\n

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