Ionic impurity analysis focuses on identifying and quantifying charged chemical species, such as inorganic ions, metal cations, and ionizable organic molecules, present as trace components in a sample. These impurities, often originating from raw materials, synthetic processes, or degradation, can significantly impact the stability, safety, and performance of final products. Accurate analysis is therefore critical across industries, from pharmaceutical development and biomanufacturing to materials science and specialty chemicals.
At BOC Sciences, we provide comprehensive ionic impurity testing services designed to meet diverse and demanding analytical needs. Our capabilities encompass routine ion chromatography for common anions and cations, ultra-trace metal analysis via ICP-MS, method development for complex matrices, and structural elucidation of unknown ionic species. Our strength lies in combining advanced instrumentation, such as high-resolution IC-MS systems, with deep technical expertise to solve challenging separation and detection problems. We serve a global clientele of researchers and quality professionals, supporting them in process optimization, formulation development, stability studies, and root-cause investigations with reliable, actionable data.
Using high-efficiency Ion Chromatography (IC) systems, we detect common anions and cations in your samples to ensure quality standards are met and minimize potential risks during production.
Analysis Items : Chloride (Cl-), Sulfate (SO42-), Nitrate (NO3-), Phosphate (PO43-), Sodium (Na+), Potassium (K+), Ammonium (NH4+), Hydroxide (OH-), Nitrite (NO2-), Fluoride (F-), Carbonate (CO32-), etc.
Using high-sensitivity techniques like ICP-MS, we provide precise detection of trace metal ion impurities to ensure your products meet safety standards.
Analysis Items : Lead (Pb), Cadmium (Cd), Arsenic (As), Mercury (Hg), Cobalt (Co), Nickel (Ni), Vanadium (V), Aluminum (Al), Zinc (Zn), Copper (Cu), Titanium (Ti), etc.
When unknown ion impurities are encountered during routine testing, we combine high-resolution mass spectrometry (HRMS) and Ion Chromatography-Mass Spectrometry (IC-MS) to accurately identify their structure and trace their origin, optimizing production processes.
Analysis Items : Degradation products, process impurities, contaminants, polar compounds, unidentified ions, etc.
For complex sample matrices (such as biopharmaceuticals or formulations with complex excipients), we offer customized method development to ensure accurate ion detection.
Analysis Items : Ion types and concentrations in complex biological matrices, ion composition in formulations with excipients, etc.
BOC Sciences offers expert ionic impurity testing with high accuracy and sensitivity, ensuring your products meet the highest quality standards.
Focus: Process-related ionic impurities in starting materials, intermediates, and active pharmaceutical ingredients (APIs).
Typical Analyses: Residual catalyst metal ions (e.g., Pd, Pt, Rh); reaction by-product ions (e.g., halides); toxic anions (e.g., nitrite, azide); and ionizable solvent residues (e.g., methylamine, triethylamine, piperidine salts).
Focus: Inorganic and ionizable impurities in finished dosage forms of various types and in functional excipients.
Typical Analyses: Degradation product ions in tablets, capsules, injectables, inhalers, etc.; impurities introduced by excipients (e.g., phosphates, sulfates); residual metal catalysts; and extractable/leachable ions from packaging material compatibility studies.
Focus: Process-related and product-related ions in macromolecular drugs and live cell-based products.
Typical Analyses: Buffer components (e.g., histidine, acetate) in monoclonal antibodies, vaccines, gene therapies; host cell residues (e.g., DNA fragments); culture media components (e.g., ammonium, lactate); and reagent residues from purification processes (e.g., trifluoroacetic acid).
Focus: Pharmaceutical-grade excipients and packaging systems in direct contact with drugs.
Typical Analyses: Inorganic impurities in excipients like microcrystalline cellulose, lactose; extractable/leachable ions (e.g., silicates, metal ions, antioxidant degradation products) from packaging systems such as glass ampoules, rubber stoppers, and polymeric materials.
Provide your sample specifications, and BOC Sciences will offer expert ionic impurity analysis tailored to your specific needs and testing requirements.
Our experts discuss your sample matrix, target ions, and required detection limits to confirm the optimal testing strategy.
You ship the samples to our lab where certified technicians conduct rigorous pre-treatment and execute the defined instrumental analysis.
Raw data is processed by specialists, validated against quality metrics, and peer-reviewed for accuracy and completeness.
We promptly deliver a comprehensive report, including all validated data, chromatograms, and expert interpretation of the results.
We employ multidimensional chromatography and high-resolution detection systems to accurately isolate and quantify complex mixtures of ions.
Our portfolio covers routine inorganics, trace metals, and organic ions, serving diverse samples from small molecules to biologics.
Achieve reliable detection of target ions at parts-per-billion levels, even in challenging matrices with complex backgrounds.
We provide end-to-end solutions, including custom method development for novel ions and complete validation packages.
Client Needs: A pharmaceutical company required precise quantification of residual palladium catalyst in a complex novel API.
Challenges: High API concentration severely interfered with standard analysis, masking the trace palladium signal and preventing accurate measurement.
Solution: We developed a customized two-dimensional chromatography method coupled with ICP-MS. The first dimension effectively separated the API matrix, while the second dimension specifically enriched and analyzed the target metal. This online matrix elimination technique bypassed tedious manual sample preparation, ensuring robust recovery and method reproducibility. Our team validated the analytical procedure, confirming its specificity and sensitivity at parts-per-billion levels.
Outcome: The client obtained reliable data on catalyst residue, enabling informed process optimization decisions.
Client Needs: A biotech firm needed to identify unknown ionic degradation products appearing in their monoclonal antibody formulation during stability studies.
Challenges: The degradation products were present at extremely low levels within a complex matrix of proteins and excipients, making isolation and identification difficult.
Solution: We implemented a targeted strategy using High-Resolution Ion Chromatography-Mass Spectrometry (IC-HRMS). The high-separation efficiency of IC isolated the ionic impurities from the biological matrix, while the HRMS provided accurate mass and fragmentation patterns. By comparing this data with known degradation pathways and in-house spectral libraries, we successfully elucidated the chemical structures of several key degradants.
Outcome: The structural insights directly informed the client's formulation strategy to enhance product shelf-life.
Client Needs: A client sought a complete ionic impurity profile for a multi-component solid oral dosage form, including both inorganic anions and organic acids.
Challenges: The sample contained multiple interfering compounds from active ingredients and excipients, requiring a method capable of resolving a broad spectrum of ions simultaneously.
Solution: We employed an integrated analytical platform combining suppressed conductivity detection and mass spectrometry. A single, optimized ion chromatography method was developed to separate and quantify common inorganic ions (e.g., chloride, sulfate) and small organic acids (e.g., formate, acetate). MS detection provided confirmatory identification for key analytes, ensuring result accuracy in the complex background.
Outcome: The client received a comprehensive ionic fingerprint of their product, crucial for quality control and batch release.
BOC Sciences provided us with precise detection of trace ionic impurities in our formulations, helping us ensure the safety and consistency of our products with confidence.
— Dr. Smith, Senior Researcher at a Biopharma Company
Thanks to BOC Sciences' tailored approach, they helped us address matrix interference in our biologics, providing clear results for complex samples and improving our overall quality control.
— Dr. Johnson, Head of Quality Assurance at a Pharmaceutical Firm
BOC Sciences' ionic impurity analysis helped us accurately measure contaminants in our environmental samples, enabling timely and informed decisions to ensure compliance and protect the environment.
— Dr. Brown, Environmental Manager at a Sustainability Organization
By using BOC Sciences' ionic impurity testing, we were able to comprehensively analyze our raw materials and identify potential risks, streamlining our quality assurance processes and enhancing product reliability.
— Dr. Lee, Product Development Lead at a Chemical Manufacturer
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