Description

Caspofungin Impurity A is a specified impurity of the antifungal drug Caspofungin Acetate, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used in research and development, method validation, and as a certified reference material for quantitative analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Caspofungin Impurity A in Caspofungin Acetate drug substance and finished products.
• Method Development & Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance: Used in routine QC testing of active pharmaceutical ingredients (APIs) to ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to determine drug shelf life.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Caspofungin Impurity A
CAS No.	1202167-57-4
Molecular Formula	C52H81N9O15
Molecular Weight	1056.26 g/mol
Synonyms	Caspofungin Related Compound A; (4R,5S)-5-[(2S,3S)-3-[(2S,3S)-3-Hydroxy-2-[(1S,2S)-1-hydroxy-2-methylpentyl]pyrrolidin-1-yl]-3-oxo-2-(pentylamino)butanamido]-4-hydroxy-6-[(1E,3E,5E,7E)-8-[(2S,3S)-3-hydroxy-2-[(1S,2S)-1-hydroxy-2-methylpentyl]pyrrolidin-1-yl]-1,3,5,7-tetramethyl-8-oxoocta-1,3,5,7-tetraen-1-yl]-2-propyl-3,4-dihydro-2H-pyran-2-carboxylic acid; Caspofungin EP Impurity A; Caspofungin USP Impurity A.
EINECS	Contact for details

Quality Control

Our Caspofungin Impurity A is manufactured under strict quality control conditions suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure high purity and accurate qualification. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and should be handled under controlled humidity conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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