Description

Tocopherol Impurity 10 is a specified impurity of tocopherol (Vitamin E) and related compounds, identified by the CAS registry number 2896-55-1. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical and nutraceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical, food supplement, and cosmetic industries who require precise impurity profiling to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in tocopherol and Vitamin E drug substances and finished products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, GC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP, JP).
• Nutraceutical & Dietary Supplement Analysis: Essential for verifying the purity and authenticity of Vitamin E ingredients in food supplements and fortified products.
• Stability Studies: Used to identify and track degradation products in tocopherol formulations during forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Cosmetic Ingredient Analysis: Applied in the quality assessment of tocopherol used as an antioxidant in skincare and cosmetic formulations.

Basic Information

Product Name	Tocopherol Impurity 10
CAS No.	2896-55-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin E Impurity 10; Tocopherol Related Compound 10; 2896-55-1; (2R)-2,5,7,8-Tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-chromen-6-ol; α-Tocopherol Impurity; d-α-Tocopherol Impurity 10; EP Impurity C (Tocopherol); USP Tocopherol Related Compound C
EINECS	Contact for details

Quality Control

Our Tocopherol Impurity 10 is manufactured under strict quality management systems. Each batch undergoes rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic techniques. Certificates of Analysis (COA) are provided, detailing results for assay, related substances, and other critical parameters. We support compliance with ICH Q3A, Q3B guidelines and relevant pharmacopeial monographs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container tightly sealed in a dry and well-ventilated place.

Specification

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