Description

Caspofungin Impurity 4 is a specified impurity of the antifungal drug Caspofungin Acetate, a critical echinocandin used in clinical settings. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and quality control units involved in the production and testing of Caspofungin drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Caspofungin Impurity 4 in drug substances and products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurities.
• Stability Studies & Forced Degradation: Employed to understand degradation pathways and establish impurity profiles under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Acts as a system suitability component and a quantitative marker to ensure drug product purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate control over the drug's impurity profile.
• Research on Degradation Chemistry: Supports studies investigating the formation, structure, and pharmacological relevance of this specific impurity.

Basic Information

Item	Details
Product Name	Caspofungin Impurity 4
CAS No.	258510-40-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Caspofungin Related Compound 4; Caspofungin EP Impurity D; Caspofungin USP Impurity D; (4R,5S)-5-[(2S,3S)-3-[(2S,3S)-3-Amino-2-hydroxy-4-phenylbutanamido]-2-hydroxy-4-phenylbutanamido]-4-hydroxy-6-[(1S,2S)-1-hydroxy-2-methylbutyl]-2-oxo-1,3-oxazane-4-carboxamide; Caspofungin Isomer; Caspofungin Degradant
EINECS	Contact for details

Quality Control

Every batch of Caspofungin Impurity 4 is produced and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC and mass spectrometry to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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