Description

Paclitaxel Impurity O CAS NO 219783-77-4 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in Paclitaxel, a critical anticancer drug. This compound is essential for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and quality assurance of Paclitaxel and its formulations.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification, method development, and validation of analytical procedures (e.g., HPLC, LC-MS) to monitor and control Paclitaxel Impurity O levels in active pharmaceutical ingredients (APIs) and finished drug products.
• Regulatory Compliance and Documentation: Critical for preparing regulatory submissions (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and establishing acceptable limits in accordance with ICH Q3A and Q3B guidelines.
• Stability Studies and Forced Degradation Testing: Used as an analytical marker to understand the degradation pathways of Paclitaxel and to establish the stability-indicating methods required for drug shelf-life determination.
• Process Chemistry Research and Optimization: Employed by chemists to study and optimize the synthesis and purification processes of Paclitaxel, helping to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC) Laboratories: Acts as a primary standard for the routine batch release testing of Paclitaxel API, ensuring every lot meets stringent purity specifications.
• Academic and Contract Research: Utilized in research settings to investigate the chemical properties, biological activity, or toxicological profile of Paclitaxel-related compounds.

Basic Information

Item	Detail
Product Name	Paclitaxel Impurity O
CAS No.	219783-77-4
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	7-Epi-10-deacetylpaclitaxel; 10-Deacetyl-7-epipaclitaxel; 7-Epi-10-DAP; Paclitaxel EP Impurity O; Taxol Impurity O; 1H-Azepin-1-one, 4,10-dihydroxy-2a,4a,7,20-tetrakis(acetyloxy)-11-[(2R,3S)-3-[(benzoylamino)-2-hydroxy-3-phenylpropanoyl]oxy]-9-oxo-5,20-epoxy-7,11-methano-7H-cyclonona[de]naphthalen-4-yl ester, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-; 10-Deacetyl-7-epitaxol
EINECS	Contact for details

Quality Control

Every batch of Paclitaxel Impurity O is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation and purity testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results for purity, impurities, and identification. Our quality processes are designed to support compliance with relevant pharmacopeial and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must 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 (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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