Description

Mometasone Furoate Impurity A is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient, Mometasone Furoate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a primary reference standard for method development, validation, and routine quality testing in the production of corticosteroid-based pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for the identification and quantification of impurities in Mometasone Furoate API and finished dosage forms.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance: Essential for in-process testing and release testing of Mometasone Furoate batches to comply with pharmacopeial monographs (USP, EP, BP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing impurity data required by agencies like the FDA and EMA.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish shelf-life for pharmaceutical products.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation mechanisms and optimize purification processes.

Basic Information

Product Name	Mometasone Furoate Impurity A
CAS No.	83880-65-3
Molecular Formula	C27H30Cl2O6
Molecular Weight	521.43 g/mol
Synonyms	9,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate); 9α,21-Dichloro-11β,17α-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate); Mometasone Furoate Related Compound A; Mometasone EP Impurity A; Mometasone USP Impurity A; 9α,21-Dichloro-16α-methyl-1,4-pregnadiene-11β,17α-diol-3,20-dione 17-(2-furoate)
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

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 ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.