Description

Tocopherol Impurity 2 CAS NO 90510-39-7 is a specific chemical reference standard used for the analytical profiling and quality control of tocopherol (Vitamin E) products. This compound is critical for ensuring the purity and safety of tocopherol raw materials and finished formulations in regulated industries. It is primarily required by pharmaceutical, nutraceutical, and high-purity chemical manufacturers for method development, validation, and routine impurity monitoring.

Application

• Pharmaceutical Reference Standard: Used for the identification, qualification, and quantification of related substances in Tocopherol (Vitamin E) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for tocopherol analysis.
• Quality Control & Assurance: Employed in-house by manufacturers and by third-party testing laboratories to verify batch-to-batch consistency and compliance with pharmacopeial monographs (e.g., USP, EP).
• Nutraceutical & Dietary Supplement Testing: Ensures the purity and label claim accuracy of Vitamin E supplements by detecting and controlling specified impurities.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in stability studies to track impurity profiles and degradation pathways of tocopherol-based formulations under various conditions.

Basic Information

Product Name	Tocopherol Impurity 2
CAS No.	90510-39-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin E Impurity 2; Tocopherol Related Compound 2; (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 impurity; Tocopherol EP Impurity B; Tocopherol USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Tocopherol Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated chromatographic methods (HPLC/GC) to ensure they meet the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is light-sensitive (store away from light) and easily oxidized (store under inert atmosphere). For long-term storage, consider storage under an inert gas such as argon or nitrogen.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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