Description

Cabazitaxel Impurity 48 is a designated impurity standard used in the analytical profiling and quality control of the anticancer drug Cabazitaxel. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, stability studies, and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cabazitaxel Impurity 48 in Cabazitaxel API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure product specifications are met according to ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research & Development: Used in studies to understand the degradation pathways and chemistry of Cabazitaxel.

Basic Information

Product Name	Cabazitaxel Impurity 48
CAS No.	949459-79-4
Molecular Formula	C45H57NO14
Molecular Weight	835.94 g/mol
Synonyms	Cabazitaxel Related Compound 48; Cabazitaxel EP Impurity J; Cabazitaxel USP Impurity; (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecah-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl (2R)-2-methylbutanoate; Cabazitaxel Degradant; Cabazitaxel Process Impurity
EINECS	Contact for details

Quality Control

Our Cabazitaxel Impurity 48 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is fully characterized and undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS). A comprehensive Certificate of Analysis (COA) is provided, detailing the results of all tests performed. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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