Description

Docetaxel Impurity 3 CAS NO 1095548-05-2 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in Docetaxel, a potent anti-cancer chemotherapy drug. This impurity standard is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) and its final drug formulations. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in quality control, method development, and stability studies.

Application

• Pharmaceutical Quality Control (QC): Primary standard for the identification and quantitative analysis of Docetaxel Impurity 3 in bulk API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical reference material to develop, optimize, and validate chromatographic methods for impurity profiling.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this specific impurity under various stress conditions to establish product shelf-life.
• Regulatory Documentation and Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development (R&D): Used in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Docetaxel.
• Pharmacopoeial Standards: Serves as a reference compound for compliance testing against pharmacopoeial monographs (e.g., USP, EP) where specified.

Basic Information

Item	Details
Product Name	Docetaxel Impurity 3
CAS No.	1095548-05-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Docetaxel Related Compound 3; Docetaxel EP Impurity C; Docetaxel USP Impurity; 7-Epi-10-oxo-docetaxel; (2R,3S)-N-Carboxy-3-phenylisoserine, 10-oxo-7-epi-docetaxel derivative; Taxotere Impurity 3; 10-Oxo-7-epi-docetaxel
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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