Description

(11Beta,17Alpha)-11,17-Dihydroxy-17-(1-Oxopropyl)Androst-4-En-3-One 17-Butyrate is a high-purity steroid derivative, also known as Budesonide EP Impurity C, serving as a critical reference standard and advanced pharmaceutical intermediate. Its value lies in enabling precise quality control and research & development for complex corticosteroid-based therapeutics. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on developing and validating inhalation and topical anti-inflammatory medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard (Budesonide EP Impurity C) for HPLC and LC-MS method development and validation in quality control laboratories.
• Active Pharmaceutical Ingredient (API) Intermediate: Key synthetic building block in the multi-step production of potent corticosteroid APIs, including Budesonide.
• Process Chemistry Research: Used in route scouting, optimization, and scale-up studies for steroid synthesis within process R&D departments.
• Metabolite & Degradation Studies: Employed in stability testing and forced degradation studies to identify and quantify related substances in final drug products.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require full characterization of potential impurities.
• Academic & Clinical Research: Serves as a precise chemical tool for investigating steroid pharmacology, receptor binding, and structure-activity relationships (SAR).

Basic Information

Product Name	(11Beta,17Alpha)-11,17-Dihydroxy-17-(1-Oxopropyl)Androst-4-En-3-One 17-Butyrate
CAS No.	76738-96-0
Molecular Formula	C28H40O6
Molecular Weight	472.62 g/mol
Synonyms	Budesonide EP Impurity C; Budesonide Impurity C; 16α,17-Butylidenebis(oxy)-11β,21-dihydroxypregna-1,4-diene-3,20-dione related compound C; 11β,21-Dihydroxy-16α,17-[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione Impurity C; 17-Butyric acid, 11,17-dihydroxy-21-(1-oxopropoxy)-, (11β,16α)-; Androst-4-ene-3-one, 11,17-dihydroxy-17-(1-oxopropyl)-, 17-butanoate, (11β,17α)-
EINECS	Contact for details

Quality Control

Our (11Beta,17Alpha)-11,17-Dihydroxy-17-(1-Oxopropyl)Androst-4-En-3-One 17-Butyrate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 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.