Description

Paclitaxel Ep Impurity I is a specified impurity of the potent anticancer drug Paclitaxel, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of Paclitaxel-based formulations. It is primarily used by professionals in pharmaceutical development, quality assurance, and regulatory affairs for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves 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: Used in High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods to establish system suitability, specificity, and detection limits.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing of Paclitaxel to monitor impurity levels and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in studies to understand the degradation pathways and metabolism of Paclitaxel.

Basic Information

Product Name	Paclitaxel Ep Impurity I
CAS No.	2157462-42-3
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	Paclitaxel Impurity I (EP); Paclitaxel EP Impurity I; 7-Epi-10-Deacetylpaclitaxel; (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; 10-Deacetyl-7-epipaclitaxel; Taxol EP Impurity I
EINECS	Contact for details

Quality Control

Every batch of Paclitaxel Ep Impurity I 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 stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (EP, USP) and ICH specifications.

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 Certificate of Analysis. 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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