Description

Docetaxel Impurity1 CAS NO 1095548-07-4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Docetaxel by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions focused on oncology drug development and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Docetaxel drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate comprehensive control of the drug substance.
• Stability Studies: Used to track the formation and levels of this impurity over time under various storage conditions, supporting shelf-life determination.
• Research & Development: Facilitates chemical and metabolic studies to understand the degradation pathways and behavior of Docetaxel.

Basic Information

Product Name	Docetaxel Impurity1
CAS No.	1095548-07-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Docetaxel Related Compound 1; Docetaxel Impurity A; Docetaxel EP Impurity A; Docetaxel USP Impurity; (1S,2S,3R,4S,7R,9S,10S,12R,15S)-4,12-Diacetoxy-15-{[(2R,3S)-3-({tert-butyl[(dimethylamino)carbonyl]amino}carbonyloxy)-2-hydroxy-3-phenylpropanoyl]oxy}-1,9-dihydroxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0³,¹⁰.0⁴,⁷]heptadec-13-en-2-yl benzoate; Docetaxel Degradant; Docetaxel Process Impurity
EINECS	Contact for details

Quality Control

Our Docetaxel Impurity1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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