Description

Vinorelbine Impurity 12 is a designated impurity standard used in the analytical profiling of the anticancer drug Vinorelbine. This compound is critical for pharmaceutical quality control, enabling the identification, quantification, and monitoring of this specific impurity during drug substance and product development. It is an essential reference material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance for Vinorelbine-based formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Vinorelbine.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to detect and quantify this specific impurity.
• Quality Control and Batch Release: Used in routine QC testing of Vinorelbine active pharmaceutical ingredient (API) and finished drug products to ensure impurity levels meet pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of Vinorelbine Impurity 12 over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control strategy and understanding of the drug's impurity profile.
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes for Vinorelbine.

Basic Information

Product Name	Vinorelbine Impurity 12
CAS No.	868596-47-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vinorelbine Related Compound 12; Impurity 12 of Vinorelbine; Vinorelbine EP Impurity 12; Vinorelbine USP Impurity 12; Deacetyl Vinorelbine (potential structural synonym); 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine (related IUPAC fragment); Navelbine Impurity 12
EINECS	Contact for details

Quality Control

Our Vinorelbine Impurity 12 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.