Description

Caspofungin Impurity 5 Acetate is a high-purity chemical reference standard, specifically identified as an impurity and degradation product of the antifungal drug Caspofungin. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, stability studies, and quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Caspofungin-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Caspofungin drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Stability Indicating Studies: Employed in forced degradation studies to identify and monitor degradation pathways of Caspofungin under various stress conditions.
• Quality Control & Batch Release Testing: Essential for setting impurity specifications and conducting routine QC testing to ensure drug product compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Mechanisms: Aids in understanding the chemical behavior and stability of Caspofungin for improved formulation development.

Basic Information

Product Name	Caspofungin Impurity 5 Acetate
CAS No.	1201042-11-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Caspofungin Acetate Impurity 5; Caspofungin Related Compound 5 Acetate; Caspofungin EP Impurity 5 Acetate; Caspofungin USP Impurity 5 Acetate; (1R,2S)-2-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-3-[(2S)-2-Amino-3-hydroxybutanoyl]-6-[(1R)-1-hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[(1R)-1-hydroxy-2-(methylamino)-2-oxoethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.0⁹,¹³]heptacosan-18-yl]-2-hydroxy-N²-[(4R,5S)-5-[(2-aminoethyl)amino]-4-hydroxy-6-methylheptanoyl]-N¹,3-dihydroxybutanediamide acetate; Caspofungin Acetate Degradation Product.
EINECS	Contact for details

Quality Control

Our Caspofungin Impurity 5 Acetate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH Q3A/B and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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%
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.