Description

Vinorelbine N'B-Oxide Sulfate Salt is a chemically modified derivative of the potent vinca alkaloid vinorelbine, primarily utilized as a key reference standard and an important intermediate in advanced pharmaceutical research and development. This compound is critical for analytical method development, impurity profiling, and metabolic studies related to the parent anticancer drug. It serves the needs of pharmaceutical R&D laboratories, analytical testing facilities, and academic institutions focused on oncology drug discovery, quality control, and pharmacokinetic research.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified standard for the identification and quantification of related substances in Vinorelbine drug substance and finished products.
• Impurity Profiling & Characterization: Essential for method development and validation in HPLC and LC-MS analyses to monitor and control process-related impurities.
• Metabolic Studies: Employed in preclinical and clinical research to investigate the metabolic pathways and biotransformation products of Vinorelbine.
• Analytical Research: A critical tool for academic and industrial scientists studying the stability, degradation pathways, and formulation compatibility of vinca alkaloid-based therapeutics.
• Quality Control & Assurance: Integral to establishing specifications and release criteria for Vinorelbine active pharmaceutical ingredients (APIs) in compliance with regulatory guidelines (e.g., ICH Q3A/B).

Basic Information

Product Name	Vinorelbine N'B-Oxide Sulfate Salt
CAS No.	74075-34-6
Molecular Formula	C45H54N4O10 • H2SO4
Molecular Weight	911.02 g/mol (for the sulfate salt)
Synonyms	Vinorelbine N-Oxide Sulfate; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine Nb-Oxide Sulfate; Navelbine Impurity F (N-Oxide) Sulfate; 5'-Noranhydrovinblastine Nb-Oxide Sulfate; Vinorelbine Related Compound F Sulfate; (3α,16α)-Eburnamenine-14-carboxylic Acid, 4-(Acetyloxy)-6,7-didehydro-15-[(2R,6R,8S)-4-ethyl-1,3,6,7,8,9-hexahydro-2,6-methano-2H-azecino[4,3-b]indol-8-yl]-3-hydroxy-16-methoxy-1-methyl-, Methyl Ester, 4-Oxide, Sulfate (1:1)
EINECS	Contact for details

Quality Control

Our Vinorelbine N'B-Oxide Sulfate Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for use as a reference material. Certificates of Analysis (COA) detailing batch-specific results are provided and can be tailored to support regulatory submissions under current ICH and GMP guidelines.

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 indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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