General Information

Hydrocortisone Impurities and Hydrocortisone

Daicel Pharma synthesizes more than ten high-quality Hydrocortisone impurities such as Keto Hydroxyprogesteron-17, Cortisone 17-Carboxylic Acid, Hydrocortisone (9B, 11B – Epoxide), Hydrocortisone 17-Formoxyl Impurity, Hydrocortisone E-enol aldehyde, Hydrocortisone Z-enol aldehyde, Hydrocortisone-20-acid and more, crucial in analyzing the quality, stability, and biological safety of the active pharmaceutical ingredient, Hydrocortisone. Moreover, Daicel Pharma offers custom synthesis of Hydrocortisone impurities and delivers them globally.

Hydrocortisone [CAS: 50-23-7] is a medicine similar in chemical structure to the natural hormone produced by the adrenal glands. It is a synthetic or semisynthetic analog of the natural hydrocortisone hormone. It helps treat various medical conditions, including immune system dysfunction, cancer, inflammation, etc.

Hydrocortisone: Use and Commercial Availability

Hydrocortisone is a versatile medication treating various medical conditions affecting collagen, endocrine, allergic, rheumatic, hematologic, respiratory, gastrointestinal, neoplastic, ophthalmic, etc. Based on the patient’s condition Hydrocortisone is available in various forms, including tablets, enemas, topical ointments with antibiotics, and topical creams with acyclovir for cold sores. Hydrocortisone is marketed under different brand names worldwide, including Cortef, Solu-Cortef, and Hydrocortone.

Hydrocortisone Structure and Mechanism of Action

The chemical name of Hydrocortisone is 11β,17,21-Trihydroxypregn-4-ene-3,20-dione. Its chemical formula is C₂₁H₃₀O_5, and its molecular weight is approximately 362.5g/mol.

Hydrocortisone inhibits the accumulation of inflammatory cells at inflammation sites. It binds to glucocorticoid receptors and inhibits inflammatory transcription factors.

Hydrocortisone Impurities and Synthesis

When Hydrocortisone is manufactured¹, impurities² may form substances that may potentially harm patients. Some impurities that can develop include 11- epimers and degradation products generated from hydrolysis or oxidation. It is necessary to monitor impurity levels in Hydrocortisone to maintain its safety and effectiveness in treating patients.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Hydrocortisone impurity standards, including Keto Hydroxyprogesteron-17, Cortisone 17-Carboxylic Acid, Hydrocortisone (9B, 11B – Epoxide), Hydrocortisone 17-Formoxyl Impurity, Hydrocortisone E-enol aldehyde, Hydrocortisone Z-enol aldehyde, Hydrocortisone-20-acid and so on. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. 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 Hydrocortisone impurity or degradation product. We also provide labeled compounds to quantify the efficacy of generic Hydrocortisone. Daicel offers highly pure isotope-labeled standards of Hydrocortisone for bioanalytical research and BA/BE studies with isotope data in CoA.