Description

Docetaxel Impurity 12 is a specified impurity of the potent anticancer drug Docetaxel, identified by CAS NO 165173-47-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control of Docetaxel drug substances and products. It is essential for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry who require high-purity reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Docetaxel Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating sensitive and specific chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Docetaxel formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Docetaxel to improve formulation strategies.
• Calibration of Equipment: Serves as a precise calibrant for analytical instruments used in pharmaceutical analysis laboratories.

Basic Information

Product Name	Docetaxel Impurity 12
CAS No.	165173-47-7
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	10-Deacetyl-7-epi-docetaxel; 7-Epi-10-deacetyldocetaxel; (2R,3S)-N-Carboxy-3-phenylisoserine, 10-deacetyl-7-epi-docetaxel ester; Docetaxel Related Compound L; Taxotere Impurity L; Docetaxel EP Impurity L; Docetaxel USP Related Compound L
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, MS, NMR) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results against predefined specifications, is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed and stored with desiccant to prevent moisture uptake, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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 guidelines

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