Description

Betamethasone Ep Impurity F is a specified impurity of Betamethasone, a potent synthetic glucocorticoid corticosteroid. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for laboratories and manufacturers in the pharmaceutical industry who require high-purity materials to ensure the safety, efficacy, and regulatory compliance of their steroid-based drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Betamethasone Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, GC) to meet ICH and pharmacopoeial guidelines (USP, EP, BP).
• Used in stability studies and forced degradation studies to understand the degradation pathways of Betamethasone.
• Essential for quality control and assurance laboratories to set appropriate specifications and ensure batch-to-batch consistency.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity profile data required for drug master files (DMFs).
• Valuable for academic and contract research organizations (CROs) conducting research on corticosteroid synthesis, metabolism, and impurity profiling.

Basic Information

Product Name	Betamethasone Ep Impurity F
CAS No.	330157-04-5
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 EP Impurity F; Betamethasone Related Compound F; (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 Ep Impurity F is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

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% w/w
Residue on Ignition	≤ 0.1%

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