Description

Paclitaxel Solution Std 0.5Mg/Ml(P) is a standardized analytical reference solution, specifically formulated for high-precision quantitative and qualitative analysis. This product is critical for ensuring accuracy and consistency in pharmaceutical research, development, and quality control processes. It is primarily needed by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in oncology drug development and testing.

Application

• Pharmaceutical Quality Control (QC): Used as a primary standard for the assay and impurity profiling of paclitaxel in bulk drug substances and finished dosage forms via HPLC and UPLC methods.
• Method Development and Validation: Serves as a critical reference material for developing, optimizing, and validating analytical methods in compliance with ICH guidelines.
• Bioanalytical Studies: Employed in pharmacokinetic and pharmacodynamic studies to calibrate equipment for measuring paclitaxel concentrations in biological matrices.
• Stability Testing: Acts as a benchmark solution to monitor the stability and degradation profiles of paclitaxel-based products under various storage conditions.
• Regulatory Compliance and Documentation: Essential for generating data for regulatory submissions to agencies like the FDA and EMA, ensuring adherence to pharmacopeial standards (e.g., USP, EP).
• Research and Development: Used in academic and industrial R&D for comparative analysis in the synthesis of new taxane derivatives or novel drug delivery systems.

Basic Information

Product Name	Paclitaxel Solution Std 0.5Mg/Ml(P)
CAS No.	379688-61-6
Molecular Formula	C47H51NO14
Molecular Weight	853.91 g/mol
Synonyms	Paclitaxel; Taxol; NSC 125973; 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine; Anzatax; Onxol; Abraxane (albumin-bound particle form); BMS-181339-01
EINECS	Contact for details

Quality Control

Our Paclitaxel Solution Standard is manufactured under strict quality management systems. Each batch is rigorously tested against certified reference materials to ensure identity, potency, and purity. The solution is characterized using validated methods including HPLC for assay determination and related substance analysis. A comprehensive Certificate of Analysis (COA), detailing all test results and traceability to primary standards, is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Due to the volatile nature of the solvent, ensure containers are securely sealed when not in use to prevent evaporation and concentration change. Keep away from heat and open flame.

Specification

Item	Specification
Appearance	Clear, colorless to pale yellow solution
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	0.45 mg/mL - 0.55 mg/mL
Related Substances (HPLC)	Total impurities ≤ 2.0%
Solvent	Specified (e.g., Methanol, Acetonitrile)
Homogeneity	Meets requirement

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