Description

Betamethasone Impurity 38 is a high-purity reference standard specifically identified as a process-related impurity or degradation product of the corticosteroid Betamethasone. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily utilized by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries for method validation and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the qualitative and quantitative analysis of Betamethasone and related drug substances.
• Method Development and Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to separate and quantify this specific impurity.
• Quality Control and Batch Release: Used in the routine testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor impurity profiles against ICH guidelines.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Betamethasone formulations.

Basic Information

Item	Detail
Product Name	Betamethasone Impurity 38
CAS No.	25121-04-4
Molecular Formula	C₂₂H₂₉FO₅
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; 16β-Methyl-9α-fluoroprednisolone; Betamethasone EP Impurity G; Betamethasone Related Compound G; 16β-Methyl-9α-fluorocorticosterone; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Betamethasone Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

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 single unknown 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.