Description

Phytonadione Impurity E CAS NO 79082-96-5 is a specified impurity of Phytonadione (Vitamin K1), a critical pharmaceutical reference standard. This compound is essential for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Phytonadione Impurity E in Vitamin K1 drug substances and products.
• Analytical Method Development: Critical for developing and optimizing HPLC, UPLC, or GC methods to separate and analyze impurities in Phytonadione.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (light, heat, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Phytonadione.

Basic Information

Item	Details
Product Name	Phytonadione Impurity E
CAS No.	79082-96-5
Molecular Formula	C31H46O2
Molecular Weight	450.70 g/mol
Synonyms	Vitamin K1 Impurity E; 2,3-Epoxyphylloquinone; 2,3-Epoxy-2,3-dihydrophylloquinone; 2,3-Epoxy-3-phytyl-1,4-naphthoquinone; Phylloquinone Epoxide; 3-Phytyl-2,3-epoxy-1,4-naphthoquinone; (2R,3S)-2,3-Epoxy-3-phytyl-1,4-naphthoquinone; Phytonadione Related Compound E
EINECS	Contact for details

Quality Control

Our Phytonadione Impurity E is manufactured and tested under strict quality systems. Each batch is characterized using advanced analytical techniques to ensure identity, purity, and stability, aligning with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all specified tests.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	Yellow to orange powder or crystalline solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.