Description

Docetaxel impurity 1/(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-acetoxy-6,9,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-4-(((2,2,2-trichloroethoxy)carbonyl)oxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1H-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl is a high-purity chemical reference standard, specifically identified as a process-related impurity of the potent anticancer drug Docetaxel. This compound is essential for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities during drug substance synthesis and final product formulation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and quantification of specific impurities in Docetaxel Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure that Docetaxel batches meet predefined impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light) to establish drug shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Docetaxel synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Docetaxel impurity 1
CAS No.	114915-19-4
Molecular Formula	C₄₅H₅₃Cl₃NO₁₈
Molecular Weight	986.25 g/mol
Synonyms	(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-Acetoxy-6,9,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-4-(((2,2,2-trichloroethoxy)carbonyl)oxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1H-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl; Docetaxel Related Compound; 7-Epi-10-oxo-docetaxel; Docetaxel Impurity; Taxotere Impurity
EINECS	Contact for details

Quality Control

Every batch of our Docetaxel impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques including HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, providing full traceability and analytical data. Our quality commitment aligns with the principles of GMP and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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