Description

Paclitaxel Impurity 9 CAS NO 1186096-50-3 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 identification and quantification during pharmaceutical development and quality control. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries focused on oncology drug development and manufacturing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Paclitaxel active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for Paclitaxel analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure Paclitaxel batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits for related substances.
• Stability Studies and Forced Degradation: Acts as a marker compound in studies to understand the degradation pathways and stability profile of Paclitaxel under various stress conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control and understanding of the drug substance.
• Research on Metabolism and Pharmacokinetics: Utilized in research settings to investigate the metabolic fate of Paclitaxel and potential related compounds in biological systems.

Basic Information

Product Name	Paclitaxel Impurity 9
CAS No.	1186096-50-3
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	Paclitaxel Related Compound 9; 7-Epi-10-Deacetylpaclitaxel; 10-Deacetyl-7-epipaclitaxel; (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; Taxol Impurity 9; Paclitaxel EP Impurity I; Paclitaxel USP Related Compound I
EINECS	Contact for details

Quality Control

Every batch of Paclitaxel Impurity 9 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS 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, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. 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 (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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