Description

Betamethasone Impurity 17 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 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: Used 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: Serves as a critical standard for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing within pharmaceutical manufacturing to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of betamethasone formulations.
• Research & Development: Supports R&D activities in synthetic chemistry and pharmacology for studying the metabolism and degradation pathways of corticosteroids.

Basic Information

Product Name	Betamethasone Impurity 17
CAS No.	330157-03-4
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-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione; Betamethasone Related Compound; Betamethasone EP Impurity; Betamethasone USP Impurity; (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 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques like HPLC, GC, and NMR 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.

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 under dry, inert conditions to maintain stability and purity.

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.