Description

Desisobutyryl Ciclesonide is a key pharmaceutical intermediate and metabolite of the active corticosteroid ciclesonide. This compound is of significant importance in the development and quality control of advanced respiratory medications, particularly inhalers for asthma and allergic rhinitis. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the synthesis, analysis, and regulatory submission of next-generation anti-inflammatory therapies.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: A critical precursor in the synthesis of Ciclesonide, a leading-edge corticosteroid.
• Pharmaceutical Reference Standard: Used as a high-purity standard in HPLC, LC-MS, and other analytical methods for quality assurance and impurity profiling.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism and efficacy of ciclesonide.
• Formulation Development: Employed in R&D for developing new drug delivery systems, such as metered-dose and dry powder inhalers.
• Regulatory Compliance & Documentation: Serves as a characterized material for regulatory filings (e.g., with FDA, EMA) requiring detailed impurity and degradation pathway information.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) specializing in steroid-based API production.

Basic Information

Product Name	Desisobutyryl Ciclesonide
CAS No.	161115-59-9
Molecular Formula	C32H43NO7
Molecular Weight	553.69 g/mol
Synonyms	Desisobutyryl-Ciclesonide; 16α,17α-[(R)-Cyclohexylmethylene]bis(oxy)-11β-hydroxy-21-(2-methyl-1-oxopropoxy)-pregna-1,4-diene-3,20-dione; 11β,16α,17α,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with cyclohexanecarboxaldehyde, 21-isobutyrate; RPR 251526; Ciclesonide Impurity; Ciclesonide Metabolite; Ciclesonide Related Compound
EINECS	Contact for details

Quality Control

Our Desisobutyryl Ciclesonide is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical development. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and detailed impurity profiling via HPLC and related substances methods. A Certificate of Analysis (COA) is provided with each shipment, detailing all specified parameters to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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
Loss on Drying	≤ 0.5%

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