Description

Betamethasone Ep Impurity G is a specified impurity and degradation product of the potent corticosteroid Betamethasone. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Betamethasone drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Betamethasone active pharmaceutical ingredients (APIs).
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Betamethasone.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure compliance with pharmacopeial limits (e.g., EP, USP, ICH Q3B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Betamethasone.

Basic Information

Product Name	Betamethasone Ep Impurity G
CAS No.	85700-75-0
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 G; Betamethasone Related Compound G; Betamethasone Impurity G; 16β-Methylbetamethasone; (11β,16β)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our Betamethasone Ep Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC for purity and assay, and spectroscopic methods for structural confirmation. We support compliance with ICH guidelines and major pharmacopeias (EP, USP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.