Description

Tocopherol Impurity 1 CAS NO 3808-26-2 is a high-purity 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 pharmaceutical and nutraceutical products containing tocopherol. It is an essential tool for analytical laboratories, quality control departments, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in tocopherol-based active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, validating, and verifying HPLC, UPLC, and GC methods in compliance with ICH Q2(R1) and USP guidelines.
• Nutraceutical & Dietary Supplement Quality Control: Employed to monitor and control impurity levels in Vitamin E supplements, ensuring product purity and meeting FCC or other relevant standards.
• Stability Studies: Used as a marker compound in forced degradation and long-term stability studies of tocopherol formulations to track impurity formation over time.
• Regulatory Compliance & Documentation: Essential for generating impurity data to support regulatory filings (e.g., CMC sections for FDA, EMA) and for audit readiness.
• Research & Development: Utilized in chemical and metabolic pathway studies related to tocopherol synthesis, degradation, and bioavailability.

Basic Information

Product Name	Tocopherol Impurity 1
CAS No.	3808-26-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5,7,8-Trimethyltocotrienol; d-Phenyl-tocotrienol; Tocotrienol, 5,7,8-trimethyl-; (2R)-2,5,7,8-Tetramethyl-2-[(3E,7E)-4,8,12-trimethyltrideca-3,7,11-trien-1-yl]-3,4-dihydro-2H-chromen-6-ol; Vitamin E related compound; Tocopherol related substance A
EINECS	Contact for details

Quality Control

Every batch of Tocopherol Impurity 1 (CAS 3808-26-2) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated analytical methods (e.g., HPLC, GC, NMR) to ensure they meet the stringent requirements for use as reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere at 2-8°C. This product is easily oxidized and light-sensitive; prolonged exposure to air, light, or elevated temperatures should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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