Description

Docetaxel Impurity 36 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Docetaxel. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and impurity profiling.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Docetaxel API and finished drug products.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical quality control laboratories.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Used in stability studies to monitor impurity formation in Docetaxel formulations under various storage conditions.
• Critical for pharmacopoeial testing to ensure compliance with standards such as USP, EP, or JP monographs for Docetaxel.
• Valuable for academic and industrial research into the degradation pathways and metabolism of Docetaxel.

Basic Information

Product Name	Docetaxel Impurity 36
CAS No.	1095547-98-0
Molecular Formula	C43H53NO14
Molecular Weight	807.88 g/mol
Synonyms	Docetaxel Related Compound 36; 7-Epi-10-oxo Docetaxel; 10-Oxo-7-epi-docetaxel; (2R,3S)-N-Carboxy-3-phenylisoserine, 10-oxo-7-epi-docetaxel derivative; Taxotere Impurity 36; Docetaxel EP Impurity G; Docetaxel Oxidative Degradation Product
EINECS	Contact for details

Quality Control

Our Docetaxel Impurity 36 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

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 must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single 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.