Description

Beclometasone Dipropionate Ep Impurity O is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound serves as a specified impurity in the pharmacopeial evaluation of Beclometasone Dipropionate, a widely used corticosteroid. It is essential for laboratories in the pharmaceutical industry requiring precise identification, quantification, and qualification of impurities to ensure drug safety and efficacy. This standard supports compliance with stringent regulatory guidelines for drug substance and product development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Beclometasone Dipropionate EP Impurity O in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor and characterize degradation pathways of Beclometasone Dipropionate under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity profiles and specifications.
• Pharmacopeial Testing: Direct application in testing to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), or other international monograph requirements for Beclometasone Dipropionate.
• Quality Assurance/Quality Control (QA/QC): Serves as an in-house working standard for routine batch release testing and impurity monitoring in manufacturing.

Basic Information

Item	Detail
Product Name	Beclometasone Dipropionate Ep Impurity O
CAS No.	14527-61-8
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 Dipropionate Impurity O (EP); Beclomethasone Dipropionate Related Compound O; 16β-Methyl-9α-chloro-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione 17,21-dipropionate; BDP Impurity O; Beclometasone Impurity O; Beclomethasone Dipropionate EP Impurity O
EINECS	Contact for details

Quality Control

Every batch of Beclometasone Dipropionate Ep Impurity O is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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