Description

Vinorelbine Ep Impurity K is a high-purity chemical reference standard critical for pharmaceutical analysis and quality control. This compound is essential for the accurate identification, quantification, and monitoring of a key impurity in Vinorelbine drug substance and finished products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and structural elucidation of Vinorelbine Ep Impurity K in active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC testing of Vinorelbine tartrate to ensure impurity levels are within specified limits per ICH guidelines.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Utilized in R&D to study the degradation pathways and chemistry of Vinorelbine, aiding in process improvement and formulation stability.

Basic Information

Item	Detail
Product Name	Vinorelbine Ep Impurity K
CAS No.	218128-75-7
Molecular Formula	C45H54N4O8
Molecular Weight	778.94 g/mol
Synonyms	Vinorelbine EP Impurity K; Vinorelbine Impurity K; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine; 5'-Noranhydrovinblastine; (3α,4β,5α,12α,19α)-4-(Acetyloxy)-15-[(5S,7R,9S)-5-ethyl-1,4,5,6,7,8,9,10-octahydro-5-hydroxy-9-(methoxycarbonyl)-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylic acid methyl ester
EINECS	Contact for details

Quality Control

Every batch of Vinorelbine Ep Impurity K is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure it meets the exacting standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

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 CoA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white 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
Water Content (KF)	≤ 5.0%

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