Description

Propofol Impurity 7 is a specified impurity and degradation product of the widely used intravenous anesthetic agent, Propofol. Its identification and quantification are critical for ensuring the safety, efficacy, and regulatory compliance of the final pharmaceutical product. This reference standard is essential for analytical laboratories in the pharmaceutical industry, particularly those involved in research and development, quality control, and stability testing of Propofol formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Propofol Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Critical for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurities in Propofol.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure Propofol batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research on Degradation Pathways: Facilitates research into the chemical degradation mechanisms of Propofol, aiding in formulation optimization.

Basic Information

Product Name	Propofol Impurity 7
CAS No.	161070-01-5
Molecular Formula	C12H18O
Molecular Weight	178.27 g/mol
Synonyms	2,6-Diisopropyl-1,4-benzoquinone; 2,6-Diisopropyl-p-benzoquinone; 2,6-Diisopropyl-1,4-cyclohexadienedione; 2,6-Diisopropylquinone; Propofol Quinone; Propofol Degradant; Propofol Related Compound
EINECS	Contact for details

Quality Control

Our Propofol Impurity 7 is manufactured under strict quality systems. Each batch undergoes rigorous identity confirmation and purity analysis using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

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. This compound is light-sensitive (store away from light) and should be handled under inert conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to brown crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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