Description

Betamethasone Ep Impurity I CAS NO 185613-69-8 is a high-purity chemical reference standard, specifically identified as an epimeric impurity of the corticosteroid Betamethasone. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a benchmark in analytical method development and validation. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in the research, development, and manufacturing of steroid-based APIs and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Betamethasone epimeric impurities in drug substances and products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing to ensure Betamethasone APIs and formulations meet stringent pharmacopeial (USP, EP, BP) purity specifications.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Facilitates process chemistry research aimed at minimizing the formation of this specific impurity during Betamethasone synthesis.

Basic Information

Product Name	Betamethasone Ep Impurity I
CAS No.	185613-69-8
Molecular Formula	C22H29FO5
Molecular Weight	392.46 g/mol
Synonyms	9α-Fluoro-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione; 16β-Methyl-9α-fluoroprednisolone; Betamethasone 16β-Epimer; Betamethasone EP Impurity B; Betamethasone Isomer; (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 I is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference standards. A detailed Certificate of Analysis (CoA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with the needs of cGMP-compliant environments.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown 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.