Description

Vinflunine Ditartrate CAS NO 194468-36-5 is a high-purity, semi-synthetic vinca alkaloid derivative and a key pharmaceutical active ingredient. It serves as a critical intermediate in the development and manufacturing of advanced oncology therapeutics. This compound is essential for pharmaceutical R&D laboratories, API manufacturers, and contract research organizations (CROs) focused on innovative cancer treatments.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in the formulation of injectable oncology drugs.
• Oncology Research & Development: A vital reference standard and building block in the discovery and development of novel chemotherapeutic agents targeting various cancers.
• Contract Manufacturing: Sourced by CDMOs (Contract Development and Manufacturing Organizations) for the commercial-scale production of finished dosage forms under cGMP.
• Analytical Reference Standard: Used in quality control laboratories for method development, validation, and routine assay testing via HPLC and other chromatographic techniques.
• Preclinical & Clinical Studies: Essential material for conducting pharmacological, toxicological, and bioavailability studies during drug development phases.

Basic Information

Product Name	Vinflunine Ditartrate
CAS No.	194468-36-5
Molecular Formula	C49H58F2N4O8 • 2C4H6O6
Molecular Weight	1073.1 g/mol
Synonyms	Vinflunine Ditartrate; VFL Ditartrate; 20',20'-Difluoro-3',4'-dihydrovinorelbine Ditartrate; BMS-710485 Ditartrate; (3'α,4'α)-20',20'-Difluoro-15-oxo-3',4'-dihydrovinorelbine Ditartrate; 4'-Deoxy-20',20'-difluoro-15-oxovinorelbine Ditartrate; Javlor® (brand name salt form)
EINECS	Contact for details

Quality Control

Our Vinflunine Ditartrate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing all test results against release specifications is provided with every shipment.

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 dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (on anhydrous basis)
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%
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.