Description

Propofol Impurity 4 (Propofol EP Impurity D) is a specified impurity used in the quality control and analytical profiling of the anesthetic agent Propofol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of the final drug substance. It is primarily utilized in research and development, method validation, and as a certified reference standard for HPLC and GC analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Propofol EP Impurity D in Propofol drug substance and formulations.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying chromatographic methods (HPLC, GC) to monitor impurities in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Used in routine QC testing of Propofol Active Pharmaceutical Ingredient (API) to ensure batch-to-batch consistency and adherence to pharmacopeial specifications (EP, USP).
• Stability Studies: Employed to track the formation of this specific degradation product during forced degradation and long-term stability studies of Propofol.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity profiles and characterization data.
• Research on Degradation Pathways: Used in research to study the degradation mechanisms and stability profile of Propofol under various conditions.

Basic Information

Product Name	Propofol Impurity 4 (Propofol EP Impurity D)
CAS No.	40946-46-1
Molecular Formula	C12H18O
Molecular Weight	178.27 g/mol
Synonyms	2,6-Diisopropylphenol Impurity D; 1,3-Bis(1-methylethyl)-2-hydroxybenzene (related isomer); Propofol Related Compound D; 2,6-Di(propan-2-yl)phenol Impurity; EP Impurity D of Propofol; Propofol European Pharmacopoeia Impurity D; 2,6-Diisopropyl-1-hydroxybenzene (isomer); Disoprofol Impurity D
EINECS	Contact for details

Quality Control

Our Propofol Impurity 4 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and Mass Spectrometry to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, impurities, and chromatographic profiles. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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