Description

Budesonide Impurity 18 is a specified impurity of the active pharmaceutical ingredient (API) Budesonide, a potent glucocorticoid used in the treatment of asthma and other inflammatory conditions. This compound is critical for pharmaceutical manufacturers and analytical laboratories engaged in the research, development, and quality control of budesonide-based drug products. It serves as a vital reference standard for ensuring product purity, safety, and regulatory compliance. Professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) rely on this high-purity impurity standard to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Budesonide Impurity 18 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure budesonide API and formulations comply with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of budesonide.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate control strategies for the drug manufacturing process.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of budesonide, enabling process optimization and impurity minimization.

Basic Information

Product Name	Budesonide Impurity 18
CAS No.	95943-95-6
Molecular Formula	C25H34O6
Molecular Weight	430.53 g/mol
Synonyms	16α,17α-Butylidenebis(oxy)-11β,21-dihydroxypregna-1,4-diene-3,20-dione; Budesonide Related Compound B; Budesonide EP Impurity B; 22R-Budesonide Impurity; (22R)-16α,17α-Butylidenebis(oxy)-11β,21-dihydroxypregna-1,4-diene-3,20-dione; Budesonide Isomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Budesonide Impurity 18 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques such as HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH and major pharmacopeia (USP/EP) guidelines for impurity standards.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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