Description

Docetaxel Impurity 46 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Docetaxel. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in the production of oncology drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Docetaxel API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits.
• Stability Studies & Forced Degradation: Employed to monitor impurity formation and profile changes in Docetaxel under various stress conditions.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Docetaxel batches meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Regulatory Documentation & Submission: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Docetaxel to improve formulation stability.

Basic Information

Product Name	Docetaxel Impurity 46
CAS No.	157240-36-3
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	Docetaxel Related Compound 46; (2R,3S)-3-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoic Acid 10-Deacetylbaccatin III Ester; 7-Epi-10-Deacetyl Docetaxel; 10-Deacetyl-7-epi-docetaxel; 7-Epi-10-deacetyldocetaxel; Docetaxel EP Impurity J; Docetaxel Impurity J (EP)
EINECS	Contact for details

Quality Control

Our Docetaxel Impurity 46 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

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 Certificate of Analysis. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.