Description

Paclitaxel Impurity 8 is a specified impurity of the potent anticancer drug Paclitaxel, identified by the CAS number 28865-97-6. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control of Paclitaxel drug substances and products. It is primarily required by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Paclitaxel active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to monitor impurity profiles in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to establish acceptance criteria, ensure batch-to-batch consistency, and maintain compliance with pharmacopeial standards (USP, EP, JP).
• Stability Studies: Used to track the formation of degradation products in Paclitaxel formulations under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies for drug approval.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes for Paclitaxel by identifying and minimizing the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Paclitaxel Impurity 8
CAS No.	28865-97-6
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	10-Deacetyl-7-epitaxol; 7-Epi-10-deacetyltaxol; Paclitaxel EP Impurity H; Paclitaxel Related Compound H; Taxol Impurity H; 7-Epi-10-deacetylpaclitaxel; 10-Deacetyl-7-epipaclitaxel; 7-Epitaxol C
EINECS	Contact for details

Quality Control

Every batch of Paclitaxel Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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%
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.