Description

Betamethasone Impurity 50 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of betamethasone-based pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Betamethasone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods such as HPLC and UPLC for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in betamethasone formulations under various stress conditions.
• Research & Development: Used in R&D to study the metabolic pathways, degradation chemistry, and synthesis pathways of betamethasone and related corticosteroids.
• Quality Control Testing: Acts as a system suitability standard and a comparator in the routine QC release testing of betamethasone batches to ensure impurity limits are met.

Basic Information

Product Name	Betamethasone Impurity 50
CAS No.	116522-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione Impurity; Betamethasone Related Compound; Betamethasone EP Impurity; Betamethasone USP Impurity; 16β-Methyl-9α-fluoroprednisolone Impurity; Betamethasone Process Impurity; Corticosteroid Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Impurity 50 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters.

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 COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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