Description

Betamethasone EP Impurity J 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, a potent corticosteroid. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Betamethasone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Essential for analytical method development and validation (e.g., HPLC, UPLC) in compliance with ICH guidelines.
• Critical component in stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Used in pharmaceutical research to study the degradation pathways and metabolism of Betamethasone.
• Serves as a calibration standard in quality control laboratories for routine batch release testing.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for submission to agencies like the US FDA and European Medicines Agency (EMA).

Basic Information

Product Name	Betamethasone EP Impurity J
CAS No.	18383-24-9
Molecular Formula	C₂₂H₂₉FO₅
Molecular Weight	392.46 g/mol
Synonyms	9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; Betamethasone Impurity J; Betamethasone Related Compound J; 16β-Methyl-9α-fluoro-1,4-pregnadiene-11β,17α,21-triol-3,20-dione; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione; Betamethasone Process Impurity J; Betamethasone EP Impurity J (18383-24-9)
EINECS	Contact for details

Quality Control

Every batch of Betamethasone EP Impurity J is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with each shipment and is available upon request.

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.

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%
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.