Description

Paclitaxel Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the widely used anticancer drug, Paclitaxel, by serving as a key marker for impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies focused on oncology drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Paclitaxel active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for Paclitaxel analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Paclitaxel formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory agencies like the FDA and EMA.
• Research on Degradation Pathways: Facilitates studies on the chemical stability and degradation mechanisms of Paclitaxel.

Basic Information

Product Name	Paclitaxel Impurity 2
CAS No.	959572-72-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-Epi-10-Deacetylpaclitaxel; 10-Deacetyl-7-epipaclitaxel; Paclitaxel EP Impurity B; Paclitaxel Related Compound B; Taxol Impurity B; (2α,4α,5β,7β,10β,13α)-4,10-Bis(acetyloxy)-13-{[(2R,3S)-3-(benzoylamino)-2-hydroxy-3-phenylpropanoyl]oxy}-1,7-dihydroxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate
EINECS	Contact for details

Quality Control

Our Paclitaxel Impurity 2 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents. A comprehensive Certificate of Analysis (COA) detailing all test results and confirming compliance with relevant standards is provided with every shipment.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 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.