Chromatography Platform

Chromatography Platform

The Chromatography Platform is a high-efficiency, multi-functional analytical system dedicated to pharmaceutical raw material inspection, finished product quality control, impurity research and formulation stability evaluation. It integrates liquid chromatography, gas chromatography, ion chromatography and related supporting detection modules, covering comprehensive separation and quantitative analysis of various pharmaceutical components. The following table summarizes its core advantages and mainstream pharmaceutical application scenarios.

Technology Type Core Advantages Applicable Scenarios
High Performance Liquid Chromatography (HPLC) High separation efficiency, stable performance, wide sample adaptability
  • Main drug content determination
  • Related substance impurity detection,
  • Dissolution and release test
Ultra High Performance Liquid Chromatography (UPLC) Fast analysis speed, high resolution, low solvent consumption
  • High-throughput batch sample testing
  • Trace impurity rapid screening
Gas Chromatography (GC) Excellent separation for volatile components
  • Residual solvent detection
  • Fatty acid composition analysis
  • Volatile impurity testing
Ion Chromatography (IC) Specific separation of ionic compounds
  • Inorganic salt content, anions and cations detection in pharmaceutical preparations

Chromatography Platform

PharmaAnalytica's Chromatography Platform unifies HPLC, UPLC, GC, and ICs, enabling precise separation, identification and quantitation of active pharmaceutical ingredients, impurities, residual solvents and ionic components, meeting the stringent purity and quality testing requirements of pharmaceutical research, production quality control and regulatory compliance.

EClassical 3200 HPLC

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EClassical 3200 HPLC features a modular design, auto-sampling function, intelligent optical path calibration and multi-detector compatibility (UV, DAD, RID). It supports routine content assay and related substance analysis of chemical drugs, and biological preparations, with stable operation and good data reproducibility, fully complying with GMP and data integrity requirements, ideal for daily quality control and batch release testing.

LC5190 UHPLC System

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LC5190 UHPLC adopts an innovative low-pressure ultra-high performance design, compatible with sub-2μm columns. It has high detection sensitivity (pg-level), fast analysis speed and excellent method transferability, which can quickly complete high-throughput sample testing and trace impurity profiling, effectively improving testing efficiency while ensuring compliance with EP, and USP standards.

GC6100 Gas Chromatography System

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GC6100 Gas Chromatography System focuses on high automation and intelligence, with self-tuning PID control and temperature-pressure compensation for stability. It supports connection with self-developed mass spectrometers, features high-precision electronic gas path control and multiple detectors, suitable for residual solvent detection, volatile impurity testing and volatile active ingredient analysis, meeting pharmacopoeia requirements for pharmaceutical testing.

IC6600 Multifunctional Ion Chromatography System

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IC6600 Multifunctional Ion Chromatography System adopts a modular design with high flexibility and easy operation. It supports configurable conductivity, amperometric and UV detectors, enabling simultaneous analysis of anions/cations, cyanide, iodide, sugars, small organic acids and transition metals. It meets routine and advanced testing needs for ionic impurities in pharmaceuticals, pharmaceutical water and biopharmaceutical formulations.

Core Chromatography Analysis Services

Raw Material & Auxiliary Material Incoming Inspection

Conduct strict quality screening for pharmaceutical raw materials, excipients, and intermediates. It involves qualitative identification of raw materials, content determination, and detection of harmful impurities (such as heavy metals, residual solvents, and organic impurities), eliminating unqualified materials from the source of production.

Drug Related Substance & Impurity Profiling

Systematically identify and quantify trace related substances, process-related impurities, and degradation products in drugs. It is applicable to impurity tracking during drug R&D, process optimization, and long-term stability testing, ensuring drug safety and consistency.

Pharmaceutical Process Research & Optimization

Support pharmaceutical production process research and optimization, including monitoring the content of intermediates during the production process, optimizing reaction conditions, and verifying the rationality of the production process. Improve production efficiency, reduce impurity generation, and ensure the stability and controllability of the production process.

Finished Pharmaceutical Product Quality Inspection

Focus on the quality verification of final pharmaceutical products, including accurate content determination of active pharmaceutical ingredients (APIs), detection of related substances and degradation products, and verification of product uniformity. Ensure finished products meet EP, USP standards and enterprise internal quality specifications before batch release.

Pharmaceutical Water Quality Monitoring

Monitor the quality of pharmaceutical water (purified water, water for injection, etc.), including the detection of inorganic anions/cations, microorganisms, and other harmful impurities. It provides reliable data support for the safe use of pharmaceutical water in production and formulation.

PharmaAnalytica Chromatography Platform provides one-stop standardized chromatographic testing solutions for the pharmaceutical industry. With complete matched analytical instruments and mature pharmacopoeia verification methods, it provides accurate, stable and compliant data support for pharmaceutical enterprise research and development, production quality control and global market registration declaration.

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