Description

Vinorelbine Ep Impurity G is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the manufacturing of the anticancer drug Vinorelbine. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Vinorelbine active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with specifications from USP, EP, ICH, and other regulatory bodies.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies of Vinorelbine to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Vinorelbine Ep Impurity G
CAS No.	72311-64-9
Molecular Formula	C₄₅H₅₄N₄O₈
Molecular Weight	778.94 g/mol
Synonyms	Vinorelbine Related Compound G; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine; 20'-Epivinorelbine; (3α,4β,5α,12α,19α)-4-(Acetyloxy)-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-6,7-didehydroaspidospermidine-3-carboxylic acid methyl ester; Vinorelbine EP Impurity G; Vinorelbine Impurity G; 20'-Epi-Vinorelbine
EINECS	Contact for details

Quality Control

Every batch of Vinorelbine Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, USP, and EP 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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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