Description

Phytonadione Impurity 3 is a designated reference standard used in the analytical profiling and quality control of Vitamin K1 (Phytonadione) active pharmaceutical ingredients (APIs) and finished drug products. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the pharmaceutical and life sciences industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Phytonadione Impurity 3 in Vitamin K1 drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing, validating, and transferring robust chromatographic methods in quality control laboratories.
• Stability Indicating Method: Used to monitor the formation of this impurity during forced degradation studies and long-term stability testing of Phytonadione formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Pharmaceutical R&D: Aids in synthetic route optimization and impurity fate mapping during the development of Phytonadione manufacturing processes.
• Quality Control Testing: Enables in-house QC labs to perform accurate assay and related substance tests against a qualified standard.

Basic Information

Product Name	Phytonadione Impurity 3
CAS No.	50281-47-5
Molecular Formula	C31H46O2
Molecular Weight	450.70 g/mol
Synonyms	Vitamin K1 Impurity 3; Phylloquinone Impurity 3; 2-Methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione; 2-Methyl-3-[(E,7R,11R)-3,7,11,15-tetramethylhexadec-2-en-1-yl]naphthalene-1,4-dione; trans-Phytonadione Impurity C; (E)-Phytonadione Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Phytonadione Impurity 3 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, GC, NMR, and MS to confirm identity and establish purity. A detailed Certificate of Analysis (COA) is provided with each lot, documenting batch-specific results. Our quality protocols are designed to support compliance with cGMP and ICH Q3B (R2) guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive (store away from light). Keep the container tightly sealed in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	Yellow to orange 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 individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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