Description

Docetaxel Impurity 16 is a specified impurity of the potent anticancer drug Docetaxel, identified by the CAS number 194235-04-6. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of Docetaxel formulations. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Docetaxel active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch release testing to ensure drug substance and product compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Docetaxel.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Docetaxel during synthesis and formulation processes.

Basic Information

Product Name	Docetaxel Impurity 16
CAS No.	194235-04-6
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	10-Deacetyl-7-epi-docetaxel; 7-Epi-10-deacetyldocetaxel; (2R,3S)-3-[[(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4,12-Diacetoxy-1,9-dihydroxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl]oxy]-2-hydroxy-3-phenylpropanoic acid tert-butyl ester; Docetaxel Related Compound I; Docetaxel EP Impurity I
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 16 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C. This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

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

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