Description

Cabazitaxel Impurity 1 is a designated reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Cabazitaxel during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories involved in the production and regulatory compliance of oncology drugs. The availability of this well-characterized impurity supports robust analytical method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Cabazitaxel drug substance and finished products.
• Analytical Method Development: Used to develop, optimize, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Employed as a system suitability standard and for routine batch testing in QC laboratories to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of Cabazitaxel formulations.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Cabazitaxel.

Basic Information

Product Name	Cabazitaxel Impurity 1
CAS No.	2983453-05-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabazitaxel Related Compound 1; Cabazitaxel Impurity A; Cabazitaxel EP Impurity A; Cabazitaxel USP Impurity; Cabazitaxel Degradation Product; Jevtana Impurity 1; Taxoid Impurity; (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)-4a,11-dihydroxy-4,6-dimethoxy-4a,6,9,10,11,12,12a,12b-octahydro-9,11-epoxy-1H-naphtho[2,1-b]pyrano[3,4-e]pyran-2,5,7,13-tetrone
EINECS	Contact for details

Quality Control

Every batch of Cabazitaxel Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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