Description

Budesonide Impurity CAS NO 192057-49-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Budesonide through rigorous impurity profiling. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial standards and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Budesonide API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and GC analytical methods for purity testing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation and growth of degradation products in Budesonide formulations under various stress conditions.
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and metabolic pathways of Budesonide.

Basic Information

Product Name	Budesonide Impurity
CAS No.	192057-49-1
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; Budesonide EP Impurity; Budesonide USP Impurity; (11β,16α)-16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione; 16α,17α-(Butylidenebis(oxy))-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Budesonide Impurity CAS 192057-49-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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 individual 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.