Description

2-Isopropyl-6-Propylphenol (Propofol Impurity O) is a critical pharmaceutical reference standard and impurity used in the quality control of the widely used anesthetic agent, Propofol. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the calibration of analytical instruments and validation of testing methods in compliance with ICH and pharmacopeial guidelines.
• Impurity Profiling & Control: Used for the identification, monitoring, and quantification of Propofol Impurity O during the synthesis, purification, and stability testing of Propofol API (Active Pharmaceutical Ingredient).
• Analytical Method Development: A key component in developing and optimizing HPLC, GC, and LC-MS methods for impurity analysis in Propofol formulations.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submissions (e.g., for FDA, EMA) by providing necessary data on impurity levels as per ICH Q3A/B requirements.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various storage conditions.
• Research & Development: Used in chemical research to study the metabolism, degradation pathways, and synthesis by-products of Propofol.

Basic Information

Product Name	2-Isopropyl-6-Propylphenol (Propofol Impurity O)
CAS No.	74663-48-2
Molecular Formula	C12H18O
Molecular Weight	178.27 g/mol
Synonyms	2-(1-Methylethyl)-6-propylphenol; 6-Propyl-2-isopropylphenol; Phenol, 2-isopropyl-6-propyl-; Propofol Related Compound O; Propofol Impurity O; 2-Isopropyl-6-propyl-phenol; Impurity O of Propofol
EINECS	Contact for details

Quality Control

Our 2-Isopropyl-6-Propylphenol (Propofol Impurity O) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with cGMP and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. This material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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