Description

Beclomethasone Dipropionate Impurity 6 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 regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for accurate impurity profiling and maintaining stringent pharmacopeial standards.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in beclomethasone dipropionate active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate impurity detection.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of beclomethasone dipropionate to monitor impurity formation over time and under various stress conditions.
• Research and Development (R&D): Used in synthetic chemistry and pharmaceutical R&D to study impurity formation pathways and to develop robust purification processes.

Basic Information

Product Name	Beclomethasone Dipropionate Impurity 6
CAS No.	72559-87-6
Molecular Formula	C28H37ClO7
Molecular Weight	521.04 g/mol
Synonyms	9α-Chloro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate; Beclomethasone Dipropionate Related Compound; Beclomethasone Impurity F; Beclomethasone Dipropionate EP Impurity F; Beclomethasone Dipropionate USP Related Compound; BDP Impurity 6; 16β-Methyl-9α-chloro-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione 17,21-dipropionate
EINECS	Contact for details

Quality Control

Every batch of Beclomethasone Dipropionate Impurity 6 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with in-house specifications aligned with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP and ISO guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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