Description

Paclitaxel Impurity 20 is a high-purity reference standard used for the analytical profiling and quality control of the potent anticancer drug, Paclitaxel. This impurity is critical for ensuring the safety and efficacy of pharmaceutical formulations by enabling accurate identification and quantification during method development and stability studies. It is an essential material for research and quality assurance laboratories in the pharmaceutical and biotechnology sectors, supporting compliance with stringent regulatory requirements for drug substance purity.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments (HPLC, LC-MS) in quality control laboratories.
• Method Development and Validation: Used in the development, optimization, and validation of chromatographic methods for the analysis of Paclitaxel and related substances.
• Stability Studies: Employed to monitor the formation of degradation products in Paclitaxel drug substance and finished product stability programs under ICH guidelines.
• Regulatory Compliance and Filing: Provides necessary impurity data for regulatory submissions (e.g., FDA, EMA) to establish impurity profiles and specifications.
• Research and Development: Aids in the study of Paclitaxel's degradation pathways and metabolism for process improvement and new formulation development.
• Pharmacopoeial Testing: Supports testing procedures aligned with compendial standards (USP, EP) for related substances in Paclitaxel.

Basic Information

Product Name	Paclitaxel Impurity 20
CAS No.	2097541-16-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paclitaxel Related Compound 20; Paclitaxel Degradant 20; Taxol Impurity 20; 7-Epi-10-Deacetylpaclitaxel (Potential Isomer/Related Structure); (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(Acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,9,11-tetrahydroxy-4a,8,13,13-tetramethyl-7-oxo-5-oxo-5H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl benzoate (Example IUPAC); 10-Deacetylpaclitaxel derivative; Paclitaxel Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Paclitaxel Impurity 20 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment supports compliance with cGMP and relevant pharmacopoeial guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 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.