What Is Dexamethasone Glyoxal Analog? - aquigenbio/blog GitHub Wiki

Dexamethasone Glyoxal Analog (CAS №84449‑15‑0) is a chemically defined impurity and analog of the corticosteroid dexamethasone. It is also known as 21‑carboxy dexamethasone and is considered a glyoxal derivative formed under oxidative degradation conditions. With a molecular formula of C₂₂H₂₇FO₆ and a molecular weight of approximately 406.5 g/mol, this impurity plays a critical role in analytical and regulatory workflows. Role and Applications Reference Standard in Analytical Testing Dexamethasone Glyoxal Analog is used as a certified reference standard in pharmaceutical analysis. It supports method validation, impurity profiling, and quality control processes for dexamethasone-based formulations. Laboratories involved in the development of generic drugs rely on such impurities for accurate impurity quantification and regulatory submission. Impurity Profiling and Stability Studies As a known degradation product of dexamethasone, this analog is essential in stability testing and forced degradation studies. Its presence in stability samples can indicate potential degradation pathways and help in developing robust formulation and storage strategies. Chemical and Safety Profile CAS Number: 84449‑15‑0 Synonym: 21‑carboxy dexamethasone Molecular Formula: C₂₂H₂₇FO₆ Molecular Weight: 406.5 g/mol Purity: Typically greater than 96 to 98 percent Usage: Intended strictly for analytical and research use; not for human or veterinary use

Proper handling includes using personal protective equipment, working in a fume hood, and adhering to laboratory safety guidelines. Importance of Glyoxal Analog Detection Dexamethasone can degrade into glyoxal-related compounds through oxidation during manufacturing or storage. This degradation may be catalyzed by light, temperature, pH changes, or metal ions. The presence of such impurities must be detected and quantified as part of ICH guidelines for impurity limits and drug stability. Dexamethasone Glyoxal Analog helps ensure that degradation products remain within acceptable limits, safeguarding both product quality and regulatory compliance. Summary Dexamethasone Glyoxal Analog is an essential impurity reference standard used in pharmaceutical quality control and regulatory filings. Its inclusion in analytical testing enhances the reliability of impurity profiling and supports the overall stability assessment of dexamethasone-based products. For laboratories and manufacturers working with corticosteroid formulations, the availability and proper use of such impurity standards are critical to ensuring product safety, efficacy, and regulatory adherence.