Description

Docetaxel Impurity 37 CAS NO 1095547-96-8 is a high-purity chemical reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient Docetaxel. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is essential for method development, validation, and routine testing in the production of oncology drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Docetaxel drug substance and finished products.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and third-party testing labs to ensure batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf life.
• Research & Development: Serves as a key intermediate or by-product marker for synthetic chemists to optimize Docetaxel manufacturing processes and improve yield.

Basic Information

Product Name	Docetaxel Impurity 37
CAS No.	1095547-96-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4,12-Diacetoxy-15-{[(2R,3S)-3-{[(tert-butoxy)carbonyl]amino}-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 Related Compound 37; A potential degradation product or process-related impurity of Docetaxel.
EINECS	Contact for details

Quality Control

Every batch of Docetaxel Impurity 37 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, related substances, and identification (IR, MS). We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants and an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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