Description

2,2-Dimethyl-4-Isopropyl-1,3-Benzodioxole (Propofol Impurity L) is a high-purity chemical reference standard critical for pharmaceutical quality control. This compound serves as a specified impurity in the synthesis and analysis of the widely used anesthetic agent, Propofol. It is an essential material for analytical laboratories, regulatory bodies, and pharmaceutical manufacturers engaged in method development, validation, and ensuring drug safety and compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Propofol Impurity L in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, GC, or LC-MS methods to monitor impurities in Propofol synthesis.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Research & Development: Employed in studies to understand the formation, fate, and degradation pathways of impurities during Propofol manufacturing and storage.
• Contract Research Organizations (CROs): Utilized by third-party testing labs offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	2,2-Dimethyl-4-Isopropyl-1,3-Benzodioxole (Propofol Impurity L)
CAS No.	201166-22-5
Molecular Formula	C12H16O2
Molecular Weight	192.25 g/mol
Synonyms	Propofol Impurity L; 2,2-Dimethyl-4-(1-methylethyl)-1,3-benzodioxole; 4-Isopropyl-2,2-dimethyl-1,3-benzodioxole; 1,3-Benzodioxole, 2,2-dimethyl-4-(1-methylethyl)-; Diisopropylphenol Impurity L; 2,6-Diisopropylphenol Related Compound L
EINECS	Contact for details

Quality Control

Every batch of 2,2-Dimethyl-4-Isopropyl-1,3-Benzodioxole (Propofol Impurity L) is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). For long-term stability, consider storage under inert atmosphere. Keep container tightly sealed to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.