Description

Cabazitaxel Impurity CAS NO 949459-76-1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Cabazitaxel, a key chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Cabazitaxel API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish specificity, accuracy, and detection limits.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products in Cabazitaxel formulations under various stress conditions.
• Research & Development: Facilitates studies on the metabolism, pharmacokinetics, and toxicology of Cabazitaxel and its related substances.

Basic Information

Product Name	Cabazitaxel Impurity
CAS No.	949459-76-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound; Cabazitaxel Impurity Standard; Cabazitaxel Specified Impurity; Cabazitaxel Degradation Product; Cabazitaxel Process Impurity; Jevtana Impurity; XRP6258 Impurity
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity is manufactured under strict quality systems to ensure batch-to-batch consistency and traceability. Each lot undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and impurity profile. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP standards for pharmaceutical reference materials.

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 should be handled in a low-humidity environment. For long-term stability, consider storage under inert atmosphere or desiccant.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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