Description

Propofol Related Impurity 1 (CAS NO 153752-00-2) is a high-purity chemical reference standard used for the identification, qualification, and quantification of a specific process-related impurity in the active pharmaceutical ingredient (API) Propofol. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the widely used anesthetic agent. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) engaged in analytical method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Primary reference standard for the identification and control of a specified impurity in Propofol API and its formulations.
• Analytical Method Development & Validation: Used as a critical system suitability component for developing and validating HPLC, UPLC, or GC methods for Propofol analysis.
• Quality Control & Release Testing: Serves as a quantitative standard in routine QC testing to ensure Propofol batches meet stringent pharmacopeial (e.g., USP, EP) or internal specification limits for related substances.
• Stability Studies: Employed to monitor the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Contract Laboratory Testing: A vital reagent for third-party testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Item	Details
Product Name	Propofol Related Impurity 1
CAS No.	153752-00-2
Molecular Formula	C12H18O
Molecular Weight	178.27 g/mol
Synonyms	2,6-Diisopropylphenol Impurity 1; 1,3-Diisopropyl-2-hydroxybenzene; 2,6-Bis(1-methylethyl)phenol related compound; Propofol Impurity A (Potential designation); 2-Hydroxy-1,3-diisopropylbenzene; Phenol, 2,6-bis(1-methylethyl)- (related substance); Process Impurity of 2,6-Diisopropylphenol
EINECS	Contact for details

Quality Control

Every batch of Propofol Related Impurity 1 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including confirmation of structure and high purity determination. A detailed Certificate of Analysis (COA) is supplied with each shipment, containing results from identity (IR, NMR), purity (HPLC), and related substance tests. 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, typically between 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.