Description

Vitamin K1 Impurity 1 is a high-purity reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the synthesis of Vitamin K1 (Phytonadione). It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical and nutraceutical industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for method development and validation in HPLC and LC-MS analysis of Vitamin K1 drug substances and products.
• Quality Control & Assurance (QC/QA): Used as a system suitability standard and for calibrating analytical instruments to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research & Development (R&D): Employed in stability studies and degradation pathway elucidation to understand the behavior of Vitamin K1 under various conditions.
• Contract Research Organizations (CROs): A vital tool for laboratories offering analytical testing services to pharmaceutical clients.
• Academic Research: Used in universities and research institutes studying the chemistry, metabolism, and analysis of Vitamin K and related compounds.

Basic Information

Item	Detail
Product Name	Vitamin K1 Impurity 1
CAS No.	19274-66-9
Molecular Formula	C31H46O2
Molecular Weight	450.70 g/mol
Synonyms	Phytonadione Impurity 1; Vitamin K1 EP Impurity 1; (2E,7R,11R)-3,7,11,15-Tetramethyl-2-hexadecene-1,4-dione; 2-Hexadecene-1,4-dione, 3,7,11,15-tetramethyl-, (2E,7R,11R)-; trans-Phytylmenadione; Menadione Phytyl Derivative; K1 Impurity A (in some contexts); Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Vitamin K1 Impurity 1 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 reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen or argon) at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is light-sensitive and easily oxidized; prolonged exposure to air, light, or elevated temperatures should be avoided to maintain stability and purity.

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)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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