Identity, purity/impurities, residual solvents, elemental impurities, Karl Fischer water, pH/osmolality, and optional sodium content trending.test

We finalize a protocol with acceptance criteria, then execute accuracy, precision, specificity, linearity/range, LoD/LoQ, robustness, and system‑suitability runs as required by ICH Q2(R2).

Yes. We perform transfer with verification, instrument suitability checks, and documentation, then proceed to validation if requested.

Development typically needs ≥ 300–500 µg per iteration; validation requires additional aliquots for accuracy/precision/robustness runs.