Description

Budesonide Impurity 30 is a designated impurity of the active pharmaceutical ingredient (API) Budesonide, a potent glucocorticoid steroid. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Budesonide-based drug products. The availability of well-characterized impurities like this is essential for meeting stringent global regulatory requirements for drug substance and drug product specifications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Budesonide Impurity 30 in API and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling of Budesonide.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Budesonide formulations.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during the synthesis of Budesonide, enabling process optimization.

Basic Information

Product Name	Budesonide Impurity 30
CAS No.	2408495-97-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Budesonide Related Compound 30; Budesonide EP Impurity I; Budesonide USP Impurity; Budesonide Process Impurity; 16α,17α-Butylidenebis(oxy)-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione Related Substance; (11β,16α)-16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione Impurity
EINECS	Contact for details

Quality Control

Our Budesonide Impurity 30 is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results against stringent in-house specifications aligned with pharmacopeial expectations. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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