Description

Vitamin K2 Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing Vitamin K2 (Menaquinone) by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and analytical method development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Vitamin K2 active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits (e.g., ICH Q3A/B).
• Stability Studies: Employed as a marker to track degradation pathways and establish shelf-life for Vitamin K2 formulations under various storage conditions.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Synthesis: Serves as a building block or intermediate in the research-scale synthesis of novel Vitamin K2 analogs or related compounds.

Basic Information

Product Name	Vitamin K2 Impurity 9
CAS No.	587888-42-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Menatetrenone Impurity 9; Menaquinone-4 Impurity 9; Vitamin K2 (MK-4) Impurity 9; (2E,6E,10E)-2,6,10,14,18,22,26,30-Octamethyldotriaconta-2,6,10,14,18,22,26,30-octaen-1-ol (Related); MK-4 Related Compound; Vitamin K2 Analog; Phytonadione Impurity (Related)
EINECS	Contact for details

Quality Control

Our Vitamin K2 Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term stability, consider storage at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%

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