Description

Sevoflurane Impurity 8 is a specified impurity and reference standard used in the analytical profiling of the inhalation anesthetic Sevoflurane. Its precise identification and quantification are critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product. This high-purity standard is essential for quality control laboratories in the pharmaceutical industry, particularly those involved in the development, manufacturing, and regulatory compliance of anesthetic drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sevoflurane Impurity 8 in Sevoflurane drug substance and drug product.
• Analytical Method Development & Validation: Critical for developing and validating sensitive and specific analytical methods, such as HPLC, GC, and GC-MS, for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels against established pharmacopeial (e.g., USP, EP) or internal specifications to ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific degradation product over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports process chemistry research aimed at minimizing the formation of this impurity during the synthesis and purification of Sevoflurane.

Basic Information

Product Name	Sevoflurane Impurity 8
CAS No.	32793-53-6
Molecular Formula	C4H3F7O
Molecular Weight	200.06 g/mol
Synonyms	1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane; Sevoflurane Related Compound; Fluoromethyl 1,1,1,3,3,3-hexafluoro-2-propyl ether (isomer); Sevoflurane EP Impurity B; Sevoflurane USP Impurity; (Fluoromethoxy)(1,1,1,3,3,3-hexafluoro-2-propyl) ether
EINECS	Contact for details

Quality Control

Every batch of Sevoflurane Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using validated chromatographic (HPLC/GC) and spectroscopic (NMR, MS) methods to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Due to its highly volatile nature, ensure containers are securely sealed and stored in a well-ventilated area.

Specification

Item	Specification
Appearance	Colorless to pale yellow liquid
Identification (IR)	Conforms to structure
Identification (GC/MS)	Conforms to structure
Purity (HPLC/GC)	≥ 95.0%
Related Substances (HPLC/GC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 0.5%

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