Impurity Test
In pharmaceutical R&D and quality control, impurity testing is a non-negotiable barrier to drug safety and regulatory compliance. Uncontrolled impurities—whether heavy metals, organic residues, ionic contaminants, or high-molecular-weight by-products—directly compromise drug efficacy, trigger adverse reactions, and risk regulatory rejection. As a leading pharmaceutical CRO, PharmaAnalytica empowers clients with a full-spectrum, technology-driven impurity testing portfolio, integrating cutting-edge analytical platforms to cover every category of impurities in Active Pharmaceutical Ingredients (APIs) and excipients. From trace heavy metals to genotoxic contaminants, our end-to-end solutions ensure materials meet ICH, USP, EP, and NMPA standards, laying a solid foundation for safe, market-ready drugs.
Core Analytical Technology Ecosystem
PharmaAnalytica has built a multi-platform testing system centered on ICP-OES, ICP-MS, SEC, IC, UPLC, GC, and LC-MS/MS, each tailored to target specific impurity types. By combining high-sensitivity spectroscopy, precise chromatography, and advanced mass spectrometry, we achieve ultra-trace detection, strong anti-matrix interference resistance, and high-throughput efficiency, addressing the most stringent impurity control requirements in API and excipient quality control.
Specialized Impurity Test Services
Heavy Metal Detection with ICP-OES
Leveraging Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), we deliver rapid, high-precision quantification of trace heavy metals (e.g., lead, arsenic, cadmium, mercury, chromium) in APIs and excipients. With a detection range down to ppb levels, this technology eliminates matrix interference from complex pharmaceutical matrices, enabling accurate, cost-effective screening for heavy metal contaminants—core to ensuring drug safety and compliance with USP <232>/<233> and ICH Q3D guidelines.
Heavy Metal Detection with ICP-MS
For ultra-trace heavy metal analysis (ppt to ppb levels), our ICP-MS service outperforms conventional methods. By coupling inductively coupled plasma with mass spectrometry, we achieve single-element detection sensitivity, enabling simultaneous quantification of multiple heavy metal impurities in a single run. Ideal for high-purity APIs and excipients with strict heavy metal limits, this service provides definitive, regulatory-ready data for toxic metal risk mitigation.
High Molecular Weight Impurity Detection with SEC
Using Size Exclusion Chromatography (SEC), we specialize in identifying and quantifying high-molecular-weight (HMW) impurities—including protein aggregates, oligomers, and polymer by-products—in biopharmaceutical APIs, peptide drugs, and excipients. With calibrated columns and automated peak analysis, we separate HMW impurities from the target compound, providing precise molecular weight distribution and impurity quantification, critical for ensuring drug stability and immunogenicity control.
Ionic Impurity Detection with Ion Chromatography (IC)
Ionic impurities (e.g., halides, sulfates, nitrates, metal ions) in APIs and excipients can disrupt drug stability and trigger adverse effects. Our IC service uses high-performance ion exchange chromatography to separate, identify, and quantify ionic contaminants with high specificity and accuracy. Whether detecting residual ionic catalysts in synthetic APIs or ionic impurities in carbohydrate excipients, we deliver compliant results aligned with pharmacopoeial limits for ionic impurity control.
Organic Impurity Analysis with UPLC
Organic impurities (synthetic intermediates, by-products, degradation products) are the most common contaminants in APIs and excipients. Powered by Ultra-Performance Liquid Chromatography (UPLC), our service offers fast, high-resolution separation of organic impurities, with UV/FLR detection for quantitative analysis. Compared to conventional HPLC, UPLC delivers higher peak capacity and faster run times, enabling efficient screening of organic impurities in complex pharmaceutical matrices and supporting ICH Q3A/Q3B compliance.
Residual Solvent Analysis with GC
Residual solvents (e.g., ethanol, acetone, dichloromethane, toluene) from API synthesis or excipient production pose serious safety risks. Our Gas Chromatography (GC)-based service—equipped with FID/MS detectors—enables sensitive, specific detection of residual solvents in APIs and excipients. We comply with ICH Q3C guidelines, quantifying solvent levels across Class 1, 2, and 3 categories, and support both direct injection and headspace sampling for diverse sample types, ensuring solvent residues stay within safe limits.
Genotoxic Impurity Determination with LC-MS/MS
Genotoxic impurities (e.g., nitrosamines, alkylating agents, aromatic amines) are trace contaminants with DNA-damaging potential, requiring ultra-sensitive detection. Our LC-MS/MS service leverages triple quadrupole technology for targeted quantification of known genotoxic impurities and screening of unknowns. With LOQ down to ppb levels and strong anti-matrix interference capability, we deliver ICH M7-compliant results, including risk assessment and control strategy recommendations, safeguarding drug candidates from genotoxic risks.
Macromolecular Impurity Analysis with ELISA
Our Macromolecular Impurity Analysis with ELISA service enables sensitive, specific quantification of key process-related macromolecular impurities in biotherapeutics, such as host cell proteins, residual enzymes, and leached or aggregated protein contaminants. We provide tailored method development, full validation, routine batch testing, and regulatory-compliant reporting to support quality control, ensure product safety and consistency, and facilitate smooth regulatory submissions across biopharmaceutical development and manufacturing.
Catalyst Residue Analysis with AAS
Leveraging Atomic Absorption Spectroscopy (AAS), we deliver sensitive, precise quantification of residual metal catalysts (e.g., palladium, platinum, nickel, ruthenium, rhodium, copper, iron) in APIs, intermediates and finished pharmaceutical products. With a detection range down to ppm and low ppb levels, this technology effectively suppresses matrix interference from complex organic systems, enabling accurate, stable and cost‑effective testing of residual metal catalysts—core to ensuring drug safety, purity and compliance with ICH Q3D, USP <232>/<233> and global regulatory limits.
Why Choose PharmaAnalytica?
Technology Leadership
Integrated multi-platform testing covers all impurity categories, from trace metals to genotoxic contaminants, ensuring comprehensive coverage.
Regulatory Expertise
All services align with ICH, USP, EP, and NMPA guidelines, with GLP-compliant reports and data traceability for regulatory submissions.
High Sensitivity & Efficiency
State-of-the-art instruments enable ultra-trace detection (ppt/ppb levels) and high-throughput testing, accelerating project timelines.
Customized Solutions
Tailored workflows adapt to API/excipient properties, synthetic routes, and project stages, from R&D screening to commercial QC.
Partner with PharmaAnalytica for precise, reliable impurity testing. We turn complex analytical challenges into actionable data, ensuring your APIs and excipients meet the highest safety and compliance standards—every batch, every time.
Online Inquiry
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Need More Information or Request A Quotation?
Related Links
