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Method Development, Validation, and Method Transfer
Finished Product and Raw Material Testing as per Pharmacopoeia
Chemistry, Manufacturing and Controls (CMC) Analytical Services
Batch Release Testing as per Regulatory Guidelines
Elemental Analysis by ICP-MS & ICP-OES (Organic-Inorganic) Techniques as per ICH Guidelines
Residual Solvents Analysis by GC
Related Substances & Organic-Inorganic Impurities Analysis
Stability Storage & Testing as per ICH Guidelines
FTIR/IR/UV Spectrometers Related Testing
Packing Material Testing such as MVTR studies
Working Standard Qualifications
Reference Standard
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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.
