AquigenBio

Catalyzing Innovation with
Aquigen’s Impurity Standards

Categories

Sort Product

Buy Empagliflozin Impurities

Showing 46–54 of 113 results

Empagliflozin Hydroxy Impurity (1‑Hydroxy Empagliflozin)

A process‑related impurity of empagliflozin, featuring an additional benzylic –OH group compared to the parent API, with molecular formula C₂₃H₂₇ClO₈ and molecular weight ≈ 466.91 g/mol.

Origins & Use:

Formed during glycosylation or reduction side‑reactions, it’s used as a certified reference standard in analytical method development, validation, and regulatory QC (e.g. ANDA/DMF filings).

Key Properties & Applications:

– Analytical Relevance: It is spiked into HPLC‑UV or LC‑MS methods to confirm chromatographic resolution and accuracy for impurity profiling.
– Regulatory Significance: Must be quantified if present ≥0.05% per ICH Q3A/Q3B guidelines for safety and compliance.

Shopping Cart