Description

Phytonadione Impurity 11 is a high-purity reference standard used in the analytical profiling of Vitamin K1 (Phytonadione). This compound is critical for pharmaceutical quality control, enabling precise identification and quantification of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is an essential tool for research and development scientists, analytical chemists, and quality assurance professionals working in pharmaceutical manufacturing and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Phytonadione (Vitamin K1) API and formulations.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity profiling in compliance with ICH Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability standard in routine QC labs to ensure the accuracy and precision of impurity assays for Phytonadione batches.
• Regulatory Submission & Compliance: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Employed to monitor the formation of degradation products in Phytonadione under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Pharmacopoeial Testing: Supports testing procedures aligned with monographs in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other pharmacopoeias.

Basic Information

Product Name	Phytonadione Impurity 11
CAS No.	22399-39-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vitamin K1 Impurity 11; Phylloquinone Impurity 11; Phytomenadione Impurity 11; 3-[(2E)-3,7-Dimethylocta-2,6-dien-1-yl]-2-methylnaphthalene-1,4-dione (related structural analog); Phytonadione Related Compound 11; Phytonadione EP Impurity 11; Phytonadione USP Impurity 11
EINECS	Contact for details

Quality Control

Every batch of Phytonadione Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic techniques (HPLC, GC) and spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Quality standards are aligned with the requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent oxidation.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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