General Information

Dexamethasone Impurities and Dexamethasone

Daicel Pharma synthesizes high-quality Dexamethasone impurities, 21-Deoxydexamethasone, Dexamethasone Formate, Dexamethasone Impurity, Dexamethasone sodium phosphate diester (Impurity I), Dexamethasone Sodium Phosphate EP Impurity G, Dexamethasone Sodium Phosphate Impurity D, and Dexamethasone sulfite adduct, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Dexamethasone. Moreover, Daicel Pharma offers custom synthesis of Dexamethasone impurities and delivers them globally.

Dexamethasone [CAS: 50-02-2] is a synthetic hormone that mimics the actions of natural corticosteroids produced by the adrenal glands. It has good anti-inflammatory and immunosuppressant properties. It treats leukemia and lymphoma.

Dexamethasone: Use and Commercial Availability

Dexamethasone is a versatile medication widely used for treating various conditions, such as multiple sclerosis, allergies, cerebral edema, inflammation, and shock. It benefits patients having asthma, atopic and contact dermatitis, and drug hypersensitivity reactions. Additionally, it’s effective in treating chemotherapy-induced nausea and vomiting, preventing and treating altitude sickness, and managing spinal cord compression caused by metastases in oncology cases. Dexamethasone is available under various brand names as the sole active ingredient or with other active pharmaceutical ingredients as a combination. The US-FDA-approved, Dexamethasone is available in different routes of administration under the brand names like Decadron, Decaderm, Dextenza, Dexycu Kit, Hemady, Maxidex, Ozurdex, etc.

Dexamethasone Structure and Mechanism of Action

The chemical name of Dexamethasone is 16α-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione. Its chemical formula is C₂₂H₂₉FO_5, and its molecular weight is approximately 392.5 g/mol.

Dexamethasone works by attaching to nuclear steroid receptors. In addition, it suppresses neutrophil migration and reduces lymphocyte colony proliferation. It interferes with the activation of NF-kB and apoptotic pathways and contribute to its therapeutic effects.

Dexamethasone Impurities and Synthesis

Dexamethasone can form impurities during its synthesis¹ or degradation. The impurities include epimers, diastereomers, and isomers. Incomplete reactions or side reactions during synthesis, as well as from degradation during storage, generate impurities. Dexamethasone impurities can affect its stability, potency, and therapeutic effectiveness. So, strict quality control measures have to be employed during production to ensure that the final product is of high quality and meets the required standards of purity and efficacy.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Dexamethasone impurity standards, 21-Deoxydexamethasone, Dexamethasone Formate, Dexamethasone Impurity, Dexamethasone sodium phosphate diester (Impurity I), Dexamethasone Sodium Phosphate EP Impurity G, Dexamethasone Sodium Phosphate Impurity D, and Dexamethasone sulfite adduct. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We also provide 13C-DEPT and CHN on request. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Dexamethasone impurity or degradation product. We provide labeled compounds to quantify the efficacy of generic Dexamethasone. Daicel offers highly pure isotope-labeled standards of Dexamethasone for bioanalytical research and BA/BE studies with isotope data in CoA.