Description

14,15-Dehydro Budesonide is a key pharmaceutical intermediate and reference standard derived from the potent glucocorticoid budesonide. This compound is essential for analytical research, method development, and quality control processes in the synthesis and validation of anti-inflammatory medications. It serves a critical role for pharmaceutical R&D laboratories, analytical service providers, and manufacturers specializing in respiratory and inflammatory disease treatments.

Application

• Pharmaceutical Reference Standard: Used for the identification, purity assessment, and quantification of budesonide and related compounds in analytical methods like HPLC and LC-MS.
• Metabolite Studies: Serves as a critical standard in pharmacokinetic and metabolic pathway research for budesonide.
• Process Impurity Profiling: Employed in the development and validation of manufacturing processes to monitor and control specific impurities.
• Analytical Method Development: A vital component for creating and calibrating stability-indicating assay methods for corticosteroid APIs.
• Chemical Synthesis Intermediate: Used in the research-scale synthesis of novel budesonide analogs and derivatives for biological evaluation.
• Quality Control & Assurance: Provides a benchmark for in-house QC testing to ensure the purity and consistency of final drug products.

Basic Information

Product Name	14,15-Dehydro Budesonide
CAS No.	131918-64-4
Molecular Formula	C25H34O6
Molecular Weight	430.53 g/mol
Synonyms	16α,17α-Butylidenebis(oxy)-11β,21-dihydroxy-14,15-dehydropregna-1,4-diene-3,20-dione; δ14,15-Budesonide; Budesonide Impurity F (EP); Budesonide Related Compound F; 14,15-Didehydro Budesonide; 14,15-Dehydro-16α,17α-butylidenebis(oxy)-11β,21-dihydroxypregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our 14,15-Dehydro Budesonide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, HPLC), assay (HPLC), and impurity profiling, to ensure it meets the high-purity standards required for pharmaceutical analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen or argon) at a controlled room temperature (15-25°C) to prevent oxidation and degradation. The container should be kept in a cool, dry, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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