Description

Phytonadione Impurity 4 CAS NO 15576-40-6 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Vitamin K1 (Phytonadione) drug products by enabling the accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs. The availability of a well-characterized impurity standard is fundamental to meeting stringent pharmacopeial requirements for drug substance and drug product specifications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Phytonadione Impurity 4 in Vitamin K1 active pharmaceutical ingredients (APIs) and finished formulations.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles during stability studies.
• Quality Control (QC) Testing: Used in routine QC release testing of Phytonadione batches to ensure impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial (USP, EP) specified limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., Drug Master Files, Common Technical Documents) by providing definitive characterization data for specified impurities.
• Stability Studies: Acts as a marker to track the formation of degradation products in Phytonadione under various stress conditions (light, heat, humidity).
• Research and Development: Facilitates research into the synthesis, degradation pathways, and metabolism of Vitamin K1 and its related compounds.

Basic Information

Product Name	Phytonadione Impurity 4
CAS No.	15576-40-6
Molecular Formula	C31H46O2
Molecular Weight	450.70 g/mol
Synonyms	Vitamin K1 Impurity 4; 2,3-Epoxy-2,3-dihydrophylloquinone; 2,3-Epoxy-2,3-dihydrophytonadione; 2,3-Epoxy-2,3-dihydro-2-methyl-3-phytyl-1,4-naphthoquinone; Phylloquinone Epoxide; Phytonadione 2,3-Epoxide; (2R,3S)-2,3-Epoxy-2-methyl-3-(3,7,11,15-tetramethylhexadec-2-en-1-yl)-2,3-dihydronaphthalene-1,4-dione
EINECS	Contact for details

Quality Control

Every batch of Phytonadione Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, analytical methods, and traceability. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated place. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	Yellow to orange powder or crystalline 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%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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