Description

Mometasone Furoate Ep Impurity J CAS NO 1370190-55-8 is a high-purity reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Mometasone Furoate. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Mometasone Furoate Ep Impurity J in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions and over shelf life.
• Research & Development (R&D): Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Mometasone Furoate Ep Impurity J
CAS No.	1370190-55-8
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	Mometasone Furoate Impurity J; Mometasone Related Compound J; 9,21-Dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl 2-furoate; (11β,16α)-9,21-Dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl bis(2-furoate); Mometasone EP Impurity J; Mometasone Furoate Process Impurity J
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Ep Impurity J is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B, USP, and EP guidelines. A detailed Certificate of Analysis (COA) with batch-specific data is provided, confirming identity, purity, and strength.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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: ≤ 0.10% Total impurities: ≤ 2.0%
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.