Description

Vinorelbine Ep Impurity F is a critical pharmaceutical reference standard used in the quality control and analytical development of the anticancer drug Vinorelbine. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a marker for a specific stereoisomeric impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing to meet stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Vinorelbine Ep Impurity F in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure drug substance and drug product batches comply with specified impurity limits as per ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemistry of Vinorelbine, aiding in process optimization.

Basic Information

Product Name	Vinorelbine Ep Impurity F
CAS No.	89368-96-7
Molecular Formula	C45H54N4O8
Molecular Weight	778.94 g/mol
Synonyms	Vinorelbine EP Impurity F; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine; 15α-Hydroxyvinorelbine; (15R)-Vinorelbine; Vinorelbine Isomer F; Vinorelbine Related Compound F; 4-Deoxy-3',4'-didehydro-8'-norvinblastine-15α-ol; A specific stereoisomer of Vinorelbine.
EINECS	Contact for details

Quality Control

Every batch of Vinorelbine Ep Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.