Description

Cabazitaxel Impurity 20 is a specified impurity and degradation product of the potent chemotherapeutic agent Cabazitaxel. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. 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 Cabazitaxel drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cabazitaxel 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.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Cabazitaxel meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to support drug approval and marketing authorization.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Cabazitaxel.

Basic Information

Product Name	Cabazitaxel Impurity 20
CAS No.	153652-67-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound 20; Cabazitaxel EP Impurity J; Cabazitaxel USP Impurity; 7,10-Dimethoxy-13-oxo-4,20-epoxytax-11-en-9-one 2,10-dibenzoate derivative (related to Cabazitaxel); Cabazitaxel Degradation Product; JTX-13 Impurity; XRP6258 Impurity; Taxoid Impurity
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity 20 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines. The material is suitable for use as a pharmaceutical reference standard.

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 inert atmosphere or in a desiccator to maintain stability and purity. Avoid repeated opening of the primary container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
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.