Description

Paclitaxel Impurity F is a critical pharmaceutical reference standard used for the identification and quantification of a specific impurity in paclitaxel drug substance and finished products. This compound is essential for ensuring the purity, safety, and efficacy of paclitaxel-based chemotherapeutics, which are vital in the treatment of various cancers. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for rigorous quality control and research and development processes.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification, qualification, and quantification of Impurity F in paclitaxel Active Pharmaceutical Ingredients (APIs) and drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for paclitaxel analysis.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure compliance with pharmacopeial standards (e.g., USP, EP) and regulatory filing specifications.
• Stability Studies: Monitors the formation of this specific degradant over time under various stress conditions to establish product shelf life.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of paclitaxel under different processing and storage conditions.

Basic Information

Item	Detail
Product Name	Paclitaxel Impurity F
CAS No.	153083-53-5
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 F; Taxol Impurity F; NSC 716088; (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 F is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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 product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.