Description

Paclitaxel Impurity 15 (Taxadiene-5-α-Acetoxy-10-β-Ol) is a key chemical reference standard used in the pharmaceutical development and quality control of the anticancer drug Paclitaxel. This impurity is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in oncology drug development and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Paclitaxel API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in GMP manufacturing environments to ensure product consistency.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to global health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor degradation pathways and establish impurity limits throughout the shelf-life of Paclitaxel formulations.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the drug's behavior and to synthesize related derivatives.

Basic Information

Product Name	Paclitaxel Impurity 15 (Taxadiene-5-α-Acetoxy-10-β-Ol)
CAS No.	337515-55-6
Molecular Formula	C22H34O3
Molecular Weight	346.51 g/mol
Synonyms	Taxa-4(20),11-dien-5α-acetoxy-10β-ol; 10β-Hydroxytaxa-4(20),11-dien-5α-yl acetate; (1S,2S,5R,7S,10R)-5-Acetoxy-10-hydroxy-4,11,11-trimethyl-8-methylidenetricyclo[7.2.1.01,6]dodec-4-ene; Paclitaxel Related Compound; Taxadiene Derivative; Taxane Impurity
EINECS	Contact for details

Quality Control

Our Paclitaxel Impurity 15 is manufactured under strict quality systems suitable for pharmaceutical reference standards. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, GC-MS, NMR, and IR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and chromatographic profiles. Our quality commitment aligns with ICH guidelines to support your regulatory needs.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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