Description

6-β-Hydroxy Budesonide is a key pharmaceutical intermediate and metabolite of the anti-inflammatory corticosteroid budesonide. This compound is of significant value in analytical and research settings for method development, pharmacokinetic studies, and as a reference standard. It is primarily needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) focusing on respiratory and inflammatory therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and qualification of budesonide and its metabolites in drug substances and products.
• Metabolite Studies: Critical for in-vitro and in-vivo pharmacokinetic research to understand the metabolic pathway, bioavailability, and clearance of budesonide.
• Analytical Method Development: Serves as a high-purity standard for developing and validating HPLC, LC-MS, and other chromatographic assays in quality control laboratories.
• Impurity Profiling: Employed to identify and control related substances during the synthesis and purification of budesonide API to meet ICH guidelines.
• Biomedical Research: Utilized in preclinical studies to investigate the pharmacological activity and safety profile of budesonide metabolites.

Basic Information

Product Name	6-β-Hydroxy Budesonide
CAS No.	88411-77-2
Molecular Formula	C25H34O7
Molecular Weight	446.53 g/mol
Synonyms	6β-Hydroxybudesonide; 16α,17α-Butylidenebis(oxy)-11β,21-dihydroxy-6β-hydroxypregna-1,4-diene-3,20-dione; Budesonide 6β-Hydroxy Metabolite; 6β-Hydroxy-16α,17α-(butylidenebis(oxy))-11β,21-dihydroxypregna-1,4-diene-3,20-dione; 6β-OH-Budesonide
EINECS	Contact for details

Quality Control

Our 6-β-Hydroxy Budesonide is manufactured and tested under strict quality management systems. Each batch is analyzed to ensure high chemical purity and identity, suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile by HPLC is provided with every shipment. We support compliance with relevant pharmacopeial and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The compound is light-sensitive; handling should be performed under appropriate conditions to minimize exposure.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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