Description

Paclitaxel Impurity 16 is a specified impurity of the potent anticancer drug Paclitaxel, identified by CAS NO 489459-83-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of Paclitaxel and its formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and ensuring drug safety and efficacy. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and regulatory submissions.

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: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in the batch release testing of Paclitaxel to ensure compliance with pharmacopeial monographs (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Paclitaxel formulations.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documents (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Paclitaxel under various environmental conditions.

Basic Information

Product Name	Paclitaxel Impurity 16
CAS No.	489459-83-8
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	7-Epi-10-Deacetylpaclitaxel; 10-Deacetyl-7-epipaclitaxel; 7-Epi-10-DAP; Paclitaxel Related Compound; Taxol Impurity; 7-Epi-10-deacetyl Taxol; 10-Deacetyl-7-epitaxol; (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-dodecah-6,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl benzoate
EINECS	Contact for details

Quality Control

Our Paclitaxel Impurity 16 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques including HPLC, NMR, and Mass Spectrometry. We ensure compliance with relevant guidelines for pharmaceutical impurities and reference standards. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% 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.