Description

Vinblastine Impurity J is a specified impurity and degradation product of the important anticancer drug Vinblastine sulfate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Vinblastine-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Vinblastine sulfate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Vinblastine and establish appropriate shelf-life specifications.
• Quality Control (QC) Testing: A critical component in the routine QC testing of Vinblastine batches to ensure compliance with pharmacopeial standards (e.g., USP, EP) and regulatory filing requirements.
• Regulatory Compliance & Documentation: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research on Degradation Chemistry: Used in academic and industrial research to study the chemical behavior, formation mechanisms, and toxicological significance of Vinblastine impurities.

Basic Information

Product Name	Vinblastine Impurity J
CAS No.	61988-79-2
Molecular Formula	C46H58N4O9
Molecular Weight	810.98 g/mol
Synonyms	Vincaleukoblastine Impurity J; 15-Oxovinblastine; 15-Oxo-VLB; 15-Ketovinblastine; Vinblastine Related Compound J; Vinblastine EP Impurity J; Vinblastine USP Impurity J; 3',4'-Didehydro-4'-deoxy-8'-norvinblastine-15-one
EINECS	Contact for details

Quality Control

Every batch of Vinblastine Impurity J is manufactured and handled under strict quality management systems. It undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profiles. Our quality commitment aligns with cGMP principles where applicable, supporting your regulatory and research needs.

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 light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity.

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%
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.