Description

Micafungin Fr-179642 Impurity (Acid) is a high-purity chemical reference standard, specifically identified as an acidic process-related impurity of the antifungal pharmaceutical agent Micafungin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quantitative and qualitative analysis of Micafungin drug substance and finished products.
• Analytical Method Development: Crucial for developing and optimizing HPLC, UPLC, and LC-MS methods to detect and quantify this specific impurity.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and regulatory submission specifications.
• Stability Studies: Employed to identify and track the formation of degradation products under various stress conditions.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Micafungin to minimize impurity formation.

Basic Information

Product Name	Micafungin Fr-179642 Impurity (Acid)
CAS No.	168110-44-9
Molecular Formula	C56H70N8O23S
Molecular Weight	1239.27 g/mol
Synonyms	FR-179642 Impurity (Acid); Micafungin Related Compound A (Acidic Form); (4R,5R)-4,5-Dihydroxy-N2-[4-[5-[4-(pentyloxy)phenyl]-3-isoxazolyl]benzoyl]-L-ornithyl-L-threonyl-trans-4-hydroxy-L-prolyl-(S)-4-hydroxy-4-(4-hydroxyphenyl)-L-threonyl-trans-3-hydroxy-L-prolyl-(3S)-3-hydroxy-L-homoalanyl-; Anidulafungin Impurity (Acid) related structure; Echinocandin B derivative impurity; Antifungal API Process Impurity.
EINECS	Contact for details

Quality Control

Every batch of Micafungin Fr-179642 Impurity (Acid) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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 guidelines

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