Description

Cabazitaxel Impurity 34 is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient, Cabazitaxel. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development, production, and regulatory compliance of Cabazitaxel-based chemotherapeutic formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cabazitaxel API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Cabazitaxel during synthesis and formulation processes.

Basic Information

Product Name	Cabazitaxel Impurity 34
CAS No.	173101-50-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound 34; Cabazitaxel Impurity C; Cabazitaxel EP Impurity C; Cabazitaxel USP Impurity; 7,10-Dimethoxy-13-oxo-4,20-epoxytax-11-en-9-one 2,10-dibenzoate derivative (related to Cabazitaxel); Jevtana Impurity 34; XRP6258 Impurity 34
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity 34 is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatographic purity, and supporting spectral information. Our quality commitment aligns with the standards expected for ICH Q3A, Q3B, USP, and EP compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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