Description

Caspofungin Impurity 12 Acetate is a high-purity chemical reference standard critical for the quality control and regulatory compliance of the antifungal drug Caspofungin. This compound serves as a specified impurity, enabling pharmaceutical manufacturers and analytical laboratories to accurately identify, quantify, and monitor this component during drug substance and product development. It is an essential material for researchers and quality assurance professionals in the pharmaceutical industry focused on method validation, stability studies, and ensuring product safety.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Caspofungin Acetate drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Used to assess the stability profile of Caspofungin formulations by tracking the level of this impurity under various stress conditions.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Pharmacopoeial Testing: Applicable for testing against specifications outlined in pharmacopoeias such as USP or EP where impurity profiles are mandated.
• Process Chemistry Research: Used by R&D scientists to understand and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Caspofungin Impurity 12 Acetate
CAS No.	1671884-43-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Caspofungin Related Compound 12 Acetate; Caspofungin EP Impurity 12 Acetate; Caspofungin USP Impurity 12 Acetate; (1R,2S)-2-[(5S,6S)-5-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-3-[(1R)-1-Hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[(1R)-1-hydroxy-2-(methylamino)-2-oxoethyl]-6,9,24-trimethyl-2,5,8,10,13,16,19,22-octaoxo-1-oxa-4,7,12,17,23-pentaazacyclopentacosan-26-yl]-6-hydroxydecahydroisoquinolin-2-yl]-2-hydroxy-1-methylethyl acetate; Caspofungin Acetate Impurity 12
EINECS	Contact for details

Quality Control

Every batch of Caspofungin Impurity 12 Acetate is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 Certificate of Analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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