Description

Tocopherol Impurity 6 is a defined chemical reference standard used for the identification and quantification of related substances in tocopherol (Vitamin E) and its formulations. This high-purity impurity standard is critical for ensuring product quality, safety, and regulatory compliance in analytical and pharmaceutical development. It is an essential material for quality control laboratories, research institutions, and manufacturers involved in the production of pharmaceuticals, nutraceuticals, and high-purity vitamin products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the analysis of tocopherol acetate, tocopherol succinate, and other Vitamin E derivatives in drug substances and products.
• Method Development and Validation: Critical for developing, validating, and verifying HPLC, UPLC, and GC analytical methods in compliance with ICH Q2(R1) and pharmacopeial guidelines.
• Quality Control and Batch Release: Used in the identification and quantitative determination of this specific impurity to ensure batches meet stringent purity specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to monitor the formation of degradation products in Vitamin E formulations under various stress conditions (heat, light, humidity).
• Nutraceutical and Cosmetic Analysis: Supports quality assurance in dietary supplements and cosmetic products containing tocopherols, ensuring impurity profiles are within safe limits.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Tocopherol Impurity 6
CAS No.	75917-94-1
Molecular Formula	C29H50O2
Molecular Weight	430.71 g/mol
Synonyms	(2R)-2,5,7,8-Tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-chromen-6-ol; 6-Hydroxy-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman; δ-Tocopherol; δ-Tocopherol; Vitamin E Impurity 6; Tocopherol Related Compound 6; (R,R,R)-δ-Tocopherol
EINECS	Contact for details

Quality Control

Every batch of Tocopherol Impurity 6 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with specified criteria. Our quality commitment supports compliance with cGMP and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under controlled humidity conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.