Description

Desflurane Related Compound A (0.1 Ml) (Bis-(1,2,2,2-Tetrafluoroethyl) Ether) is a specified impurity and reference standard used in the quality control of the inhalation anesthetic, Desflurane. This compound is critical for ensuring the purity and safety of the final pharmaceutical product by providing a benchmark for analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of anesthetic agents. The CAS number for this compound is 67429-44-1.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Desflurane drug substance and drug product.
• Analytical Method Development & Validation: Used in HPLC, GC, and GC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control (QC) Testing: Employed in routine batch release testing of Desflurane to confirm compliance with pharmacopeial specifications (e.g., USP, EP, BP).
• Stability Studies: Acts as a marker compound in forced degradation and shelf-life studies to monitor the formation of related substances over time.
• Regulatory Submissions: Essential for compiling impurity data in regulatory filings (e.g., FDA, EMA) for drug approval and market authorization.
• Research & Development: Used in synthetic chemistry and process development to understand and control the formation of by-products during Desflurane manufacturing.

Basic Information

Product Name	Desflurane Related Compound A (0.1 Ml) (Bis-(1,2,2,2-Tetrafluoroethyl) Ether)
CAS No.	67429-44-1
Molecular Formula	C4H2F8O
Molecular Weight	218.05 g/mol
Synonyms	Bis(1,2,2,2-tetrafluoroethyl) ether; 1,1,1,2,2,3,3,3-Octafluoro-3-[(1,2,2,2-tetrafluoroethoxy)methyl]propane; Desflurane Impurity A; Desflurane Related Substance A; 2,2,2-Trifluoro-1-(1,2,2,2-tetrafluoroethoxy)-1,1,2,2-tetrafluoroethane (alternative representation); Perfluoro(ethyl isopropyl) ether; Bis(perfluoroethyl) ether (common name).
EINECS	Contact for details

Quality Control

This reference standard is produced under strict quality management systems. Each batch is characterized using advanced analytical techniques to ensure high purity and accurate concentration. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, assay, and purity by chromatographic methods. Our quality protocols are designed to meet the stringent requirements of pharmaceutical impurity analysis and regulatory compliance.

Storage

Preserve in the original sealed vial as supplied, 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 the container is kept upright and handled in a well-ventilated area. Keep away from heat, sparks, 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)	≥ 98.0% (by area normalization)
Purity (HPLC/GC)	Meets lot-specific criteria on COA
Concentration	Approx. 0.1 mg/mL in specified solvent (as per label)
Solvent	As specified on label and COA (e.g., Methanol)

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