Description

Beclomethasone Dipropionate Impurity CAS NO 52092-12-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Beclomethasone Dipropionate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Beclomethasone Dipropionate Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Utilized as a marker to assess the degradation pathways and stability profile of Beclomethasone Dipropionate under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic chemistry research, metabolic studies, and the investigation of structure-activity relationships (SAR) for corticosteroid analogs.

Basic Information

Product Name	Beclomethasone Dipropionate Impurity
CAS No.	52092-12-3
Molecular Formula	C28H37ClO7
Molecular Weight	521.04 g/mol
Synonyms	9-Chloro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate; Beclomethasone 17,21-Dipropionate Related Compound; Beclomethasone Dipropionate EP Impurity; Beclomethasone Dipropionate USP Related Substance; 16β-Methyl-9α-chloro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione 17,21-dipropionate; BDP Impurity; Beclomethasone Dipropionate Analog
EINECS	Contact for details

Quality Control

Every batch of Beclomethasone Dipropionate Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification in compliance with current industry and pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data.

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 desiccated conditions.

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)	Total impurities ≤ 2.0% Any individual 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.