Description

Vitamin E Impurity D (Mixture Of Z And E Isomers) is a critical reference standard used in the analytical profiling of Vitamin E (α-Tocopherol) and related pharmaceutical products. This compound, with CAS NO 37570-32-4, is essential for ensuring product purity, safety, and regulatory compliance in high-stakes manufacturing. It is primarily utilized by quality control laboratories, research institutions, and pharmaceutical companies involved in the development, production, and validation of tocopherol-based drugs, nutraceuticals, and high-purity supplements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Vitamin E Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: Crucial for developing and validating robust HPLC, UPLC, and GC analytical methods in compliance with ICH Q2(R1) and pharmacopeial guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels, ensuring batches of Vitamin E meet stringent specifications for USP, EP, or JP monographs.
• Stability Studies: Employed to track the formation of degradation products in Vitamin E formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Nutraceutical & Cosmetic Analysis: Applied in the quality assessment of high-end dietary supplements and cosmetic products containing tocopherols to guarantee purity and label claims.

Basic Information

Product Name	Vitamin E Impurity D (Mixture Of Z And E Isomers)
CAS No.	37570-32-4
Molecular Formula	C29H50O2
Molecular Weight	430.71 g/mol
Synonyms	2,5,7,8-Tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-1-benzopyran-6-ol; 6-Hydroxy-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman; α-Tocopherol Impurity D; (2RS,4'RS,8'RS)-α-Tocopherol; DL-α-Tocopherol EP Impurity D; Tocopherol Impurity D; Vitamin E Related Compound D
EINECS	Contact for details

Quality Control

Our Vitamin E Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), isomeric ratio confirmation, and identity verification (IR, NMR) against qualified reference standards. We provide detailed Certificates of Analysis (COA) with batch-specific data, supporting compliance with current Good Manufacturing Practice (cGMP) and relevant pharmacopeial requirements. Specifications are designed to meet the needs of pharmaceutical impurity analysis and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to ambient conditions should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	Colorless to pale yellow viscous oil or solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0% (Total of Z and E isomers)
Isomeric Ratio (Z/E)	Reported on COA
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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