Description

Mometasone Furoate Ep Impurity M CAS NO 57780-86-6 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Mometasone Furoate. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products during development and manufacturing. It is primarily required by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and biotechnology industries for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Mometasone Furoate drug substance and finished products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, validating, and verifying analytical methods to monitor and control impurity levels in accordance with ICH Q3A/B guidelines.
• Stability Studies and Forced Degradation: Employed to identify and quantify degradation products in stability-indicating assays to determine drug product shelf-life.
• Quality Control and Batch Release: Serves as a system suitability and identification marker in the routine QC testing of raw materials and finished pharmaceutical formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry research to understand and optimize the manufacturing process of Mometasone Furoate, aiming to minimize this impurity.

Basic Information

Product Name	Mometasone Furoate Ep Impurity M
CAS No.	57780-86-6
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	9,21-Dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-diene-17-yl furan-2-carboxylate; Mometasone Furoate Related Compound M; Mometasone Furoate Impurity M; (11β,16α)-9,21-Dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl 2-furoate; 1,4-Pregnadiene-3,20-dione, 9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-, (11β,16α)-; Mometasone Furoate EP Impurity M
EINECS	Contact for details

Quality Control

Every batch of Mometasone Furoate Ep Impurity M is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (EP, USP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 under dry conditions 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.