Description

Cabazitaxel Impurity CAS NO 1262147-55-6 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 during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Cabazitaxel drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in API manufacturing to confirm compliance with stringent pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation and level of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to support the development of robust purification processes.

Basic Information

Product Name	Cabazitaxel Impurity
CAS No.	1262147-55-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound; Cabazitaxel Impurity Standard; Cabazitaxel Specified Impurity; (1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-(Acetyloxy)-15-{[(2R,3S)-3-{[(tert-Butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-9,12-dimethoxy-11-oxo-5,5,7,10-tetramethyl-8-oxatricyclo[10.3.1.0²,⁷]hexadec-13-en-2-yl Benzoate; Cabazitaxel EP Impurity; Cabazitaxel USP Impurity
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) containing batch-specific data on identity, purity, and impurities, supporting compliance with ICH guidelines and regulatory requirements.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified 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.