Description

Sevoflurane Related Compound A (0.2 Ml) (1,1,3,3,3-Pentafluoroisopropenyl Fluoromethyl Ether) is a specified impurity and degradation product of the inhalation anesthetic Sevoflurane. Its precise identification and quantification are critical for ensuring the safety, purity, and efficacy of the final pharmaceutical product. This compound is essential for pharmaceutical manufacturers and analytical laboratories engaged in quality control, method development, and stability studies for Sevoflurane. Rigorous control of related substances like this is a fundamental requirement for compliance with global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sevoflurane impurities in drug substance and drug product analysis.
• Analytical Method Development & Validation: Critical for developing and validating sensitive and specific analytical methods, such as Gas Chromatography (GC) and HPLC, to monitor Sevoflurane purity.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to ensure every batch of Sevoflurane meets stringent pharmacopeial specifications (e.g., USP, EP, JP) for related substances.
• Stability Studies: Employed to track the formation of degradation products over time under various storage conditions, establishing product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Supports R&D investigations into the degradation pathways and chemical stability of Sevoflurane and related compounds.

Basic Information

Product Name	Sevoflurane Related Compound A (0.2 Ml) (1,1,3,3,3-Pentafluoroisopropenyl Fluoromethyl Ether)
CAS No.	58109-34-5
Molecular Formula	C5H3F6O
Molecular Weight	196.07 g/mol
Synonyms	1,1,3,3,3-Pentafluoroisopropenyl Fluoromethyl Ether; Fluoromethyl 1,1,3,3,3-pentafluoroisopropenyl Ether; Sevoflurane Impurity A; Sevoflurane Related Substance A; Sevoflurane Degradation Product; (1,1,3,3,3-Pentafluoroprop-1-en-1-yloxy)methane; Pentafluoroisopropenyl Fluoromethyl Ether
EINECS	Contact for details

Quality Control

This analytical standard is produced and certified under strict quality management systems. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and strength, traceable to primary reference standards where applicable. Our quality protocols are designed to support compliance with cGMP, ICH Q3B guidelines, and relevant pharmacopeial monographs (USP, EP). Certificates of Analysis are available upon request and are essential for your regulatory and quality documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Due to its highly volatile nature, ensure containers are securely sealed when not in use to prevent evaporation and potential concentration changes. Keep away from heat and open flame.

Specification

Item	Specification
Appearance	Clear, colorless liquid
Identification (IR)	Conforms to reference spectrum
Identification (GC)	Retention time matches reference standard
Assay (GC)	≥ 95.0%
Purity (GC Area %)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Related Substances (GC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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