Description

Tocopherol Impurity 11 CAS NO 72657-56-8 is a high-purity chemical reference standard used for the identification and quantification of related substances in tocopherol (Vitamin E) analysis. This compound is critical for ensuring the quality, safety, and regulatory compliance of tocopherol products in pharmaceutical and nutraceutical manufacturing. It is primarily required by quality control laboratories, analytical service providers, and R&D departments involved in the development and production of Vitamin E and its formulations.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of Tocopherol Impurity 11 in active pharmaceutical ingredients (APIs) and finished drug products containing Vitamin E.
• Method Development and Validation: Used as a critical standard in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for tocopherol analysis.
• Nutraceutical and Food Supplement QC: Essential for quality control testing of Vitamin E supplements, softgel capsules, and fortified foods to monitor and control impurity levels.
• Stability Studies: Employed in forced degradation and shelf-life studies of tocopherol formulations to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Compliance and Documentation: Supports compliance with stringent pharmacopoeial standards (USP, EP, JP) and regulatory submissions (FDA, EMA) by providing a traceable impurity standard.
• Contract Research and Testing: A vital tool for CROs (Contract Research Organizations) and analytical testing laboratories offering impurity identification and characterization services.

Basic Information

Product Name	Tocopherol Impurity 11
CAS No.	72657-56-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin E Impurity 11; Tocopherol Related Compound 11; (2R)-2,5,7,8-Tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-chromen-6-ol; α-Tocopherol Impurity 11; d-α-Tocopherol Impurity 11; Tocopherol EP Impurity 11; Tocopherol USP Impurity 11
EINECS	Contact for details

Quality Control

Our Tocopherol Impurity 11 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each lot is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation, and impurity profiles. We support compliance with major pharmacopoeial guidelines, and specifications can be aligned with USP, EP, or client-specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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