Description

Cabazitaxel Impurity 32 (Mixture Of Diastereomers) is a critical pharmaceutical reference standard used in the analytical characterization and quality control of the anticancer drug Cabazitaxel. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a marker for specific synthetic by-products or degradation pathways. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Cabazitaxel formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Cabazitaxel API and finished drug products.
• Analytical Method Development & Validation: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling and stability studies.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to monitor the formation of this specific impurity over time under various storage conditions to establish product shelf-life.
• Process Chemistry Research: Aids in the optimization of Cabazitaxel synthesis by identifying and tracking the formation of this diastereomeric impurity.

Basic Information

Product Name	Cabazitaxel Impurity 32 (Mixture Of Diastereomers)
CAS No.	949459-78-3
Molecular Formula	C45H57NO14
Molecular Weight	835.94 g/mol
Synonyms	Cabazitaxel Related Compound 32; Cabazitaxel Diastereomeric Impurity; (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecah-11-hydroxy-4,6,9-trimethoxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl (2R)-2-methylbutanoate (Mixture of Diastereomers); Jevtana Impurity 32; XRP6258 Impurity 32
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity 32 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, LC-MS, and NMR, to confirm compliance with client specifications and relevant ICH guidelines. We support GMP-oriented projects and can provide materials suitable for regulatory filings.

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 desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0% (Area Percent)
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.