Description

Budesonide Impurity 6 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Budesonide. This compound is critical for ensuring the purity, safety, and efficacy of Budesonide-based pharmaceutical formulations through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Budesonide API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the sensitivity and specificity of impurity detection methods.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products in Budesonide formulations under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to understand the synthesis pathway, degradation routes, and metabolic profile of Budesonide.

Basic Information

Product Name	Budesonide Impurity 6
CAS No.	131918-73-5
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; 22R-Budesonide Impurity; Budesonide EP Impurity B; Budesonide USP Related Compound B; (22R)-16α,17α-Butylidenebis(oxy)-11β,21-dihydroxypregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Budesonide Impurity 6 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization using advanced spectroscopic and chromatographic techniques (including HPLC, NMR, and MS) to confirm identity and purity in accordance with current pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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