Description

Anidulafungin Impurity 4 is a specified impurity and degradation product of the antifungal pharmaceutical agent Anidulafungin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method development, validation, and ensuring the purity and safety of the active pharmaceutical ingredient (API).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Anidulafungin Impurity 4 in drug substance and drug product analysis.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the manufacturing process.
• Quality Control (QC) Testing: Employed in routine QC testing of Anidulafungin API and finished dosage forms to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate control strategies for known impurities.
• Research and Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Anidulafungin.

Basic Information

Product Name	Anidulafungin Impurity 4
CAS No.	54615-51-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Anidulafungin Related Compound 4; Anidulafungin EP Impurity D; Anidulafungin USP Impurity 4; (1R,2R)-2-[(2S,3S,4S,5R,6R)-4-Amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3-dihydroxy-8-methyl-9-oxononyl (4R,5R)-4,5-dihydroxy-N2-[(4R,5R)-5-[(1R,2R)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-1,3-dioxolan-4-yl]-L-ornithinate; Cyclohexyl (1R,2R)-2-[(2S,3S,4S,5R,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3-dihydroxy-8-methyl-9-oxononyl (4R,5R)-4,5-dihydroxy-N2-[(4R,5R)-5-[(1R,2R)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-1,3-dioxolan-4-yl]-L-ornithinate (deprotected form)
EINECS	Contact for details

Quality Control

Our Anidulafungin Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (e.g., by NMR and MS), to ensure identity, potency, and consistency. Certificates of Analysis (COA) are provided, detailing batch-specific results against comprehensive specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for pharmaceutical impurities.

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 COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere 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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.