Description

Mometasone Furoate Ep Impurity R is a high-purity reference standard specifically identified as an impurity of the active pharmaceutical ingredient Mometasone Furoate. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical laboratories and pharmaceutical companies focused on ensuring product safety, efficacy, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Mometasone Furoate and related drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for in-process testing and final release testing of Mometasone Furoate API to ensure compliance with EP, USP, and ICH guidelines on impurities.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes for the API.

Basic Information

Product Name	Mometasone Furoate Ep Impurity R
CAS No.	1370190-08-1
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	Mometasone Furoate Impurity R; Mometasone EP Impurity R; Mometasone Related Compound R; (11β,16α)-9,21-Dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,2'-furoate; 17,2'-Furoate, 9,21-dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-, (11β,16α)-; Mometasone Furoate Process Impurity; Mometasone Furoate Specified Impurity
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Ep Impurity R is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity. We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an 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)	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.