Description

Mometasone Furoate Impurity 9 is a high-purity chemical reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of drug products by enabling the accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Mometasone Furoate-based medications.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying this specific impurity in Mometasone Furoate drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Acts as a marker to track impurity formation during forced degradation and long-term stability studies of pharmaceutical formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in R&D to understand the synthesis pathway, degradation routes, and chemical behavior of Mometasone Furoate.

Basic Information

Product Name	Mometasone Furoate Impurity 9
CAS No.	1404070-67-2
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	9,11β-Epoxy-17-(2-furoyloxy)-16α-methyl-3-oxoandrosta-1,4-diene-21-carboxylic Acid Chloride; Mometasone Furoate EP Impurity J; Mometasone Furoate Related Compound J; Mometasone Furoate Chloroformate Impurity; (8S,9R,10S,11S,13S,14S,16R,17S)-9,11-Epoxy-17-(furan-2-carbonyloxy)-16-methyl-3-oxo-17-(propionyloxy)androsta-1,4-diene-21-carbonyl Chloride
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Impurity 9 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including NMR, MS, and HPLC against a fully characterized reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and results from all specified tests, supporting compliance with cGMP and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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