Description

Betamethasone Impurity 14 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Betamethasone-based drug products, enabling accurate identification and quantification of process-related impurities. It is essential for analytical laboratories, pharmaceutical manufacturers, and regulatory bodies focused on ensuring drug safety, efficacy, and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Betamethasone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for impurity profiling, stability indicating assays, and forced degradation studies to understand drug substance behavior.
• Regulatory Compliance & Filings: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity limits and demonstrate comprehensive control strategies for drug substances.
• Process Chemistry & Development: Employed to monitor and optimize synthesis pathways, helping to identify, track, and minimize the formation of specific impurities during manufacturing.
• Pharmacopoeial Testing: Used as a system suitability component in tests specified by USP, EP, or other international pharmacopoeias for Betamethasone monographs.
• Academic & Contract Research: Supports research in synthetic chemistry, analytical method development, and pharmaceutical sciences within academic and CRO (Contract Research Organization) settings.

Basic Information

Product Name	Betamethasone Impurity 14
CAS No.	1186336-29-7
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 Process Impurity; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione related substance; Betamethasone Specified Impurity
EINECS	Contact for details

Quality Control

Our Betamethasone Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing comprehensive specifications and test results. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

Specification

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

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