Description

Hydrocortisone Hemisuccinate Hydrate is a water-soluble ester prodrug of the natural glucocorticoid hydrocortisone. This chemical modification is critical for enhancing the bioavailability and formulation flexibility of the active pharmaceutical ingredient. It is primarily utilized in the pharmaceutical industry for the development of injectable and topical corticosteroid medications. This high-purity compound is essential for manufacturers requiring reliable and consistent raw material quality for critical therapeutic applications.

Application

• Pharmaceutical Active Ingredient (API): Primary use as a prodrug in the synthesis of injectable and topical corticosteroid formulations.
• Anti-inflammatory & Immunosuppressive Medications: Key intermediate for drugs treating conditions like adrenal insufficiency, severe allergies, and inflammatory diseases.
• Steroid Prodrug Development: Serves as a model compound in R&D for designing improved steroid delivery systems with enhanced solubility.
• Hospital Compounding: Used in pharmacy compounding for preparing patient-specific sterile injectable solutions.
• Veterinary Pharmaceuticals: Employed in anti-inflammatory treatments for animals.
• Reference Standard: Serves as an analytical standard in quality control laboratories for HPLC and other assay methods.
• Biochemical Research: Used in laboratory studies investigating glucocorticoid receptor activity and metabolic pathways.

Basic Information

Product Name	Hydrocortisone Hemisuccinate Hydrate
CAS No.	83784-20-7
Molecular Formula	C25H36O8 • xH2O
Molecular Weight	Anhydrous: 464.55 g/mol
Synonyms	Cortisol 21-hemisuccinate hydrate; 11β,17α,21-Trihydroxypregn-4-ene-3,20-dione 21-hemisuccinate; Hydrocortisone 21-hemisuccinate; Hydrocortisone 21-(hydrogen succinate); Cortisol hemisuccinate; NSC 47439; Solu-Cortef (brand name intermediate); Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, 21-(3-carboxy-1-oxopropoxy)-, (11β)-
EINECS	Contact for details

Quality Control

Our Hydrocortisone Hemisuccinate Hydrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing results from tests including HPLC assay, related substances, residual solvents, and identification. The product can be supplied to meet various pharmacopoeial standards, including USP and EP monographs, upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	Contact for details
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	Contact for details

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.