Description

Vinorelbine Tartrate is a semi-synthetic vinca alkaloid derivative, a potent antineoplastic agent specifically designed to disrupt microtubule dynamics during cell division. Its primary commercial value lies in its targeted efficacy against non-small cell lung cancer and advanced breast cancer, offering a critical therapeutic option in oncology. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing injectable formulations and is a key subject of research in novel drug delivery systems and combination therapies.

Application

• Oncological Pharmaceutical Manufacturing: As the core active ingredient in the production of injectable chemotherapy drugs, primarily for the treatment of non-small cell lung cancer (NSCLC).
• Advanced Breast Cancer Therapy: Used in formulations for treating metastatic or recurrent breast cancer, often in combination with other chemotherapeutic agents.
• Pharmaceutical Research & Development (R&D): Serves as a reference standard and a starting material for developing new anticancer formulations, prodrugs, and targeted delivery mechanisms.
• Clinical Trial Material (CTM): Supplied under strict quality protocols for use in clinical studies investigating new indications or combination regimens.
• Generic Drug Production: A critical API for manufacturers producing bioequivalent versions of established vinorelbine-based medications.
• Academic and Preclinical Studies: Used in laboratory research to study mechanisms of mitosis inhibition, drug resistance, and cancer cell biology.

Basic Information

Product Name	Vinorelbine Tartrate
CAS No.	125317-39-7
Molecular Formula	C45H54N4O8 • C4H6O6
Molecular Weight	1079.18 g/mol
Synonyms	Vinorelbine Ditartrate; 3',4'-Didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3-dihydroxybutanedioate (1:2)]; KW-2307; Navelbine Tartrate; Nor-5'-anhydrovinblastine Tartrate; 5'-Noranhydrovinblastine Tartrate; Vinorelbine Acid Tartrate
EINECS	Contact for details

Quality Control

Our Vinorelbine Tartrate is manufactured and tested to meet the stringent requirements of pharmacopeial standards for active pharmaceutical ingredients (APIs). Every batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure high purity and consistency. Certificates of Analysis (COA) documenting compliance with relevant specifications are provided with each 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) or as specified on the label. The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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