Description

Vinorelbine Ep Impurity I is a critical pharmaceutical reference standard used in the quality control and analytical development of the anticancer drug Vinorelbine. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Vinorelbine formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development & Validation: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Vinorelbine.
• Quality Control (QC) Testing: Critical for the identification and quantification of this specific impurity in Vinorelbine active pharmaceutical ingredient (API) and finished drug products to meet pharmacopeial specifications.
• Stability Studies: Employed to monitor the formation of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Compliance & Filings: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in studies to understand the degradation pathways and synthesis impurities of Vinorelbine.

Basic Information

Product Name	Vinorelbine Ep Impurity I
CAS No.	89384-09-8
Molecular Formula	C45H54N4O8
Molecular Weight	778.94 g/mol
Synonyms	Vinorelbine Impurity I; Vinorelbine EP Impurity I; 3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine; 4'-Deoxy-3',4'-didehydro-8'-norvinblastine; 4'-Deoxy-3',4'-didehydro-8'-norvincaleukoblastine; (3'α,4'α)-3',4'-Didehydro-4'-deoxy-8'-norvincaleukoblastine; Vinorelbine Related Compound I
EINECS	Contact for details

Quality Control

Our Vinorelbine Ep Impurity I is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, and NMR to confirm identity and purity, ensuring it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical results.

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) and must be kept under dry conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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