Description

Vinorelbine Ep Impurity H is a critical pharmaceutical reference standard used in the analytical profiling of Vinorelbine, a potent chemotherapeutic agent. This compound is essential for quality control and regulatory compliance in the manufacturing of high-purity active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) for method development, validation, and impurity identification studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Vinorelbine drug substance and finished products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Vinorelbine APIs meet stringent pharmacopeial specifications (e.g., EP, USP) for impurity limits.
• 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.
• Stability Studies: Used to monitor the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Aids in understanding the degradation pathways and chemistry of Vinorelbine during process development and formulation studies.

Basic Information

Product Name	Vinorelbine Ep Impurity H
CAS No.	220137-33-7
Molecular Formula	C45H54N4O8
Molecular Weight	778.94 g/mol
Synonyms	Vinorelbine EP Impurity H; Vinorelbine Related Compound H; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine; (3α,4β,5α,12α,19α)-4-(Acetyloxy)-15-[(5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino[5,4-b]indol-9-yl]-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylic acid methyl ester
EINECS	Contact for details

Quality Control

Every batch of Vinorelbine Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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