Description

Docetaxel Impurity 17 is a specified impurity of the potent anticancer drug Docetaxel, identified by CAS NO 194235-02-4. This high-purity reference standard is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities during drug manufacturing. It is an essential material for quality assurance laboratories, analytical scientists, and regulatory affairs professionals working to ensure the safety, efficacy, and compliance of Docetaxel formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Docetaxel.
• Method Development & Validation: Critical for developing and validating robust analytical methods (e.g., HPLC, LC-MS) for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control impurity levels, ensuring drug product specifications are met.
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing data on impurity identity and levels.
• Stability Studies: Employed to track the formation of degradation products in Docetaxel drug substance and product under various storage conditions.
• Research & Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and pharmacokinetics of Docetaxel.

Basic Information

Product Name	Docetaxel Impurity 17
CAS No.	194235-02-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Docetaxel Related Compound 17; 7-Epi-10-oxo-docetaxel; 10-Oxo-7-epi-docetaxel; Docetaxel EP Impurity J; Docetaxel Impurity J (EP); Taxotere Impurity 17; (2R,3S)-3-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoic Acid 10-oxo-7-epi-docetaxel Ester
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 17 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

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. Keep the container in a dry, cool, and well-ventilated area.

Specification

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

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