Description

Mometasone Furoate Ep Impurity S CAS NO 2231764-75-1 is a high-purity reference standard specifically used in the pharmaceutical quality control process. This compound is critical for the accurate identification and quantification of process-related impurities in the synthesis of Mometasone Furoate, a potent topical corticosteroid. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical development and manufacturing, ensuring drug safety and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling: Critical for identifying and quantifying this specific impurity in Mometasone Furoate Active Pharmaceutical Ingredient (API) batches.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure API purity meets EP, USP, and ICH guidelines.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to monitor impurity levels in stability samples under various storage conditions.
• Research and Development: Facilitates process chemistry research aimed at minimizing or eliminating this impurity during API synthesis.

Basic Information

Product Name	Mometasone Furoate Ep Impurity S
CAS No.	2231764-75-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mometasone Furoate Impurity S; Mometasone Furoate Related Compound S; Mometasone EP Impurity S; (8S,9R,10S,11S,13S,14S,16S,17R)-9-Chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl furan-2-carboxylate (IUPAC); Mometasone Furoate Process Impurity.
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Ep Impurity S is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data, supporting compliance with current Good Manufacturing Practice (cGMP) and relevant pharmacopeial standards.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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