Description

Mometasone Furoate Impurity F 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 regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Impurity F in mometasone furoate API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Utilized to track the formation of degradation products in mometasone furoate formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic chemistry research for impurity synthesis, characterization, and toxicological studies.

Basic Information

Product Name	Mometasone Furoate Impurity F
CAS No.	1305334-30-8
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); Mometasone Furoate Related Compound F; Mometasone EP Impurity F; Mometasone USP Impurity F; 9α,21-Dichloro-11β,17α-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate); Mometasone Furoate Impurity 6; Mometasone Furoate Process Impurity
EINECS	Contact for details

Quality Control

Our Mometasone Furoate Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the highest standards for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH, USP, and EP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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