Description

Docetaxel Impurity 4 (Oxazolidine 4S,5S Isomer) is a defined stereoisomeric impurity used as a critical reference standard in the analytical profiling of the anticancer drug Docetaxel. This compound is essential for pharmaceutical manufacturers and quality control laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily required by researchers and QC professionals in the pharmaceutical industry for method development, validation, and impurity identification studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Docetaxel active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods to monitor this specific impurity.
• Quality Control & Batch Release: Used in routine QC testing to confirm impurity levels are within specified limits as per ICH guidelines, ensuring batch-to-batch consistency.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and growth of this impurity over time under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Facilitates research into the degradation pathways and chemical behavior of Docetaxel during synthesis, formulation, and storage.

Basic Information

Product Name	Docetaxel Impurity 4 (Oxazolidine 4S,5S Isomer)
CAS No.	153744-63-9
Molecular Formula	C₄₃H₅₃NO₁₄
Molecular Weight	815.89 g/mol
Synonyms	(4S,5S)-Oxazolidine Docetaxel Impurity; Docetaxel Oxazolidine Impurity (4S,5S); Docetaxel Related Compound 4; (2'R,3S,4S,5R,13S)-4,10-Bis(acetyloxy)-13-{[(2R,3S)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate; Taxotere Impurity 4; Docetaxel EP Impurity D; Docetaxel USP Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 4 (Oxazolidine 4S,5S Isomer) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This compound is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to ambient conditions should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.