Description

Budesonide Impurity 11 is a specified impurity of the corticosteroid drug Budesonide, identified by the CAS registry number 39672-76-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Budesonide-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Budesonide API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure drug substance and product specifications meet pharmacopeial standards (e.g., USP, EP, ICH).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Research & Process Chemistry: Aids in understanding the synthesis pathway and degradation mechanisms of Budesonide to optimize manufacturing processes.

Basic Information

Product Name	Budesonide Impurity 11
CAS No.	39672-76-9
Molecular Formula	C25H34O6
Molecular Weight	430.54 g/mol
Synonyms	16α,17α-Butylidenebis(oxy)-11β,21-dihydroxypregna-1,4-diene-3,20-dione; Budesonide Related Compound; 16α,17α-[(Butylidenebis(oxy))]-11β,21-dihydroxypregna-1,4-diene-3,20-dione; Budesonide EP Impurity B; Budesonide Impurity B (EP); Budesonide Related Substance B; (11β,16α)-16,17-[Butylidenebis(oxy)]-11,21-dihydroxypregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Budesonide Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support regulatory requirements and can supply materials suitable for use as reference standards in GMP environments.

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 material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under appropriate conditions to prevent degradation.

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% w/w
Residue on Ignition	≤ 0.1%

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