Description

Mometasone Furoate Impurity D is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Mometasone Furoate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of Impurity D in Mometasone Furoate API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Assurance/Quality Control (QA/QC): Serves as a benchmark in routine quality control testing to ensure API and drug product specifications meet pharmacopeial standards (USP, EP, ICH).
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress and long-term storage conditions.
• Research and Development: Used in chemical and pharmacological research to study the properties, formation pathways, and potential biological activity of this impurity.

Basic Information

Product Name	Mometasone Furoate Impurity D
CAS No.	83881-09-8
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	9,21-Dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl diacetate; 21-Acetate Impurity of Mometasone Furoate; Mometasone Furoate EP Impurity D; Mometasone Furoate USP Impurity D; Mometasone Related Compound D; 17-Deoxy-21-acetyl Mometasone Furoate; (11β,16α)-9,21-Dichloro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl diacetate
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Impurity D is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH, USP, and EP guidelines.

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.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.