Description

Cabazitaxel Impurity 15 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Cabazitaxel. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and stability studies.

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 (HPLC/LC-MS): Essential for developing, validating, and calibrating chromatographic methods to monitor impurity profiles.
• Quality Control (QC) & Quality Assurance (QA): Serves as a critical benchmark in routine batch release testing to ensure product purity meets pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Research & Development: Used in metabolic studies, degradation pathway elucidation, and process chemistry research to optimize synthesis and purification of Cabazitaxel.

Basic Information

Product Name	Cabazitaxel Impurity 15
CAS No.	1584118-06-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound 15; Cabazitaxel Impurity; Cabazitaxel EP Impurity 15; Cabazitaxel USP Impurity 15; Jevtana Impurity 15; (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[10.3.1.0²,¹⁰]hexadec-13-en-2-yl Benzoate (IUPAC); Taxoid Derivative Impurity; Cabazitaxel Degradation Product
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity 15 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia standards for impurities in new drug substances and products.

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 dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.