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Impurity profiling involves a comprehensive process that begins with the identification of impurities, followed by their isolation and purification.
Once isolated, each impurity undergoes detailed characterization and structure elucidation (SER) to understand its properties and potential impact. The final step involves synthesis, enabling further study and regulatory compliance. This end-to-end approach ensures product safety, quality, and consistency.
Our Analytical Research & Development (ARD) department provides complete analytical solutions, including method development, method validation, method verification, impurity profiling, reference standard characterization, stability studies, and routine QC testing. We support small molecules, APIs, intermediates, excipients, and finished formulations, ensuring robust analytical data for regulatory submissions.
We follow a quality-by-design (QbD) approach and use fully calibrated and qualified instruments (HPLC, GC, LC-MS, NMR, IR, UV, KF). All studies are performed according to ICH guidelines, validated SOPs, and strict data integrity standards. Continuous system suitability checks, analyst training, and multi-level peer review ensure accurate, precise, and reproducible results.
Our ARD operations comply with ICH Q2(R2)/Q14, USP, EP, BP, and IP regulatory frameworks. Every analytical method is developed and validated as per international pharmacopeial standards, ensuring regulatory-ready documentation, traceability, and global acceptance for DMF, ANDA, and dossier submissions.
Yes. We specialize in impurity profiling, identification & quantification, isolated impurity characterization, and synthesis support for unknown impurities. Our team performs forced degradation studies, photostability testing, and long-term & accelerated stability studies as per ICH guidelines. We also provide high-purity reference standards, complete with COA, NMR, LC-MS, and HPLC purity data.
Clients receive a comprehensive Analytical Method Development Report, Method Validation Protocol, Validation Report, raw data, chromatograms, spectra, system suitability data, and regulatory-ready documentation. All reports are structured to meet ICH, FDA, and EMA expectations, supporting global filings and partner audits.
