Description

Anidulafungin Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical development of the antifungal drug Anidulafungin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Anidulafungin drug substance and finished products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection and quantification.
• Stability Studies and Forced Degradation: Employed to identify and monitor this specific impurity in stability-indicating assays during drug product shelf-life studies.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing of Anidulafungin APIs to ensure compliance with ICH guidelines and pharmacopeial monographs.
• Regulatory Submissions: Provides necessary data for impurity identification and characterization in regulatory filings (e.g., for FDA, EMA).
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Anidulafungin.

Basic Information

Product Name	Anidulafungin Impurity B
CAS No.	2099166-85-3
Molecular Formula	C58H86N10O15
Molecular Weight	1163.4 g/mol
Synonyms	Anidulafungin Related Compound B; (4R,5R)-4,5-Dihydroxy-N2-((4R,5R)-4,5-dihydroxy-1,6-diphenylhexan-2-yl)-N6-((1S,2R)-1-hydroxy-2-((4R,5S)-5-((R)-1-hydroxyethyl)-3-methyl-4-(pentyloxy)tetrahydrofuran-2-yl)propyl)-2,5-dioxopiperazine-1,6-dicarboxamide; Anidulafungin EP Impurity B; Anidulafungin USP Impurity B; Anidulafungin Process Impurity B
EINECS	Contact for details

Quality Control

Our Anidulafungin Impurity B is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity, related substances, residual solvents, and other relevant tests, supporting compliance with ICH Q3A, Q3B guidelines and pharmacopeial standards.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.