Description

Docetaxel Impurity 9 is a specified impurity of the potent anticancer agent Docetaxel, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Docetaxel drug substances and products. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Docetaxel Active Pharmaceutical Ingredient (API).
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Docetaxel formulations.
• Serves as a critical component for regulatory compliance and submission to agencies like the FDA and EMA.
• Applied in pharmaceutical research to study the metabolism and pharmacokinetics of Docetaxel.
• Utilized as a calibration standard in high-precision analytical instrumentation.

Basic Information

Product Name	Docetaxel Impurity 9
CAS No.	161759-90-6
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	10-Deacetyl-7-epitaxol; 7-Epi-10-deacetyltaxol; Docetaxel Related Compound; Taxotere Impurity; (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecah-6,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl (2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoate
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request to support your regulatory and research needs.

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 COA. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

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 single unknown impurity ≤ 1.0%
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.