Description

Mometasone Ep Impurity B is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and quality assurance of Mometasone furoate and related corticosteroid products.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying Mometasone furoate impurities in drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for purity analysis.
• Quality Control and Release Testing: Essential for routine batch analysis in GMP environments to ensure API and drug product purity meets pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Employed to monitor the formation of degradation products in Mometasone furoate formulations under various stress conditions.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Research and Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Mometasone Ep Impurity B
CAS No.	223776-49-6
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	9,11β-Epoxy-17-[(2-furanylcarbonyl)oxy]-21-chloro-11-hydroxy-16α-methylpregna-1,4-diene-3,20-dione; 9,11β-Epoxy-17-(2-furoyloxy)-21-chloro-11-hydroxy-16α-methylpregna-1,4-diene-3,20-dione; Mometasone Furoate 9,11β-Epoxide; Mometasone Furoate Impurity B; Mometasone EP Impurity B; Mometasone Related Compound B; (11β,16α)-9,11-Epoxy-21-chloro-17-(2-furanylcarbonyl)oxy-11-hydroxy-16-methylpregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our Mometasone Ep Impurity B is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for pharmaceutical analysis. Each lot undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support compliance with cGMP and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under 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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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