Description

Cabazitaxel Impurity 45 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical development of Cabazitaxel, an important chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies to ensure drug safety and efficacy.

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 and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing in GMP manufacturing environments to monitor impurity levels.
• Stability Studies: Employed to track the formation and behavior of this specific impurity during forced degradation and long-term stability testing of Cabazitaxel formulations.
• Regulatory Submissions: Provides necessary data for filing regulatory documents (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in academic and industrial R&D to study the metabolic pathways, degradation mechanisms, and toxicological profile of Cabazitaxel-related compounds.

Basic Information

Product Name	Cabazitaxel Impurity 45
CAS No.	959123-35-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound 45; Cabazitaxel Impurity C; Cabazitaxel EP Impurity C; Jevtana Impurity 45; (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-6-oxatetracyclo[10.3.1.0²,¹⁰.0⁴,⁸]hexadec-13-en-2-yl Benzoate; Taxoid Impurity; Cabazitaxel Degradation Product
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity 45 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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)	Single unspecified impurity ≤ 1.0% 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.