Description

Docetaxel Impurity 15 is a specified impurity and degradation product of the potent anticancer drug Docetaxel. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Docetaxel active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Docetaxel API and formulations.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification pathways of Docetaxel to minimize impurity formation.

Basic Information

Product Name	Docetaxel Impurity 15
CAS No.	146924-91-6
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	10-Deacetyl-7-epi-10-oxo-docetaxel; 7-Epi-10-oxo-10-deacetyl Docetaxel; (2R,3S)-3-[[(1S,2S,5R,7S,10R,11S,14R,15S)-14-[[(2R,3S)-3-[(Benzoylamino)-2-hydroxy-3-phenylpropanoyl]oxy]-2,15-dihydroxy-5,9-dimethyl-11-[(2-methyl-1-propenyl)oxy]tetracyclo[8.7.0.0²,⁷.0¹¹,¹⁵]heptadec-6-en-10-yl]oxy]-2-hydroxy-3-phenylpropanoic acid tert-butyl ester; Docetaxel Related Compound H (EP); Docetaxel Impurity H; Docetaxel EP Impurity H
EINECS	Contact for details

Quality Control

Our Docetaxel Impurity 15 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, MS, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each product, detailing batch-specific results. Our quality commitment aligns with the principles of ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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 individual unspecified 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.