Description

Docetaxel Impurity 5 CAS NO 1021489-55-3 is a high-purity chemical reference standard used for the analytical profiling and quality control of the anticancer drug Docetaxel. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for method development, validation, and stability studies in the pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in Docetaxel Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in Docetaxel formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and stability profile of Docetaxel.
• Contract Research Organizations (CROs) & Testing Labs: Provides a reliable benchmark for external testing and certification services for pharmaceutical clients.

Basic Information

Product Name	Docetaxel Impurity 5
CAS No.	1021489-55-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Docetaxel Related Compound 5; Docetaxel EP Impurity 5; Docetaxel USP Impurity 5; 7-Epi-10-oxo-docetaxel; 10-Oxo-7-epi-docetaxel; Taxotere Impurity 5; Docetaxel Degradation Product; Docetaxel Process Impurity
EINECS	Contact for details

Quality Control

Our Docetaxel Impurity 5 is manufactured under strict quality systems suitable for pharmaceutical reference standards. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data, chromatograms, and storage recommendations. Our quality commitment aligns with the standards expected for impurities and reference standards in pharmacopeial (USP, EP) applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Solubility	Soluble in acetonitrile, methanol; sparingly soluble in water

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