Description

Cabazitaxel Impurity 30 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cabazitaxel. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Cabazitaxel-based chemotherapeutic formulations.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Cabazitaxel API.
• Essential for method development and validation of HPLC and LC-MS analytical procedures in pharmaceutical R&D.
• Critical component in stability studies to monitor degradation pathways and establish shelf-life for drug products.
• Used for regulatory compliance and filing, providing necessary data for submissions to agencies like the FDA and EMA.
• Supports quality control (QC) laboratories in routine batch release testing of Cabazitaxel.
• Valuable for academic and clinical research studying the metabolism and pharmacokinetics of Cabazitaxel.

Basic Information

Product Name	Cabazitaxel Impurity 30
CAS No.	154083-99-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound 30; Cabazitaxel EP Impurity J; Cabazitaxel USP Impurity; 7,10-Dimethoxy-3-(((2R,3S)-3-((2-((1,1-dimethylethyl)dimethylsilyl)oxy)ethyl)-4-hydroxy-5-oxo-2-tetrahydrofuranyl)carbonyl)-13-oxo-4,8,11-triazatricyclo[7.4.0.02,7]trideca-1(9),2,4,6,10,12-hexaen-12-yl (2R,3S)-3-(((1,1-dimethylethyl)dimethylsilyl)oxy)-2-hydroxy-3-phenylpropanoate; Cabazitaxel Silyl Ether Impurity
EINECS	Contact for details

Quality Control

Every batch of Cabazitaxel Impurity 30 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial guidelines (e.g., USP, EP). Comprehensive characterization is performed using advanced techniques such as HPLC, GC, NMR, and MS. Certificates of Analysis (COA) detailing purity, identity, and analytical results are available upon request.

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. Store under inert atmosphere if specified. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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