Description

Micafungin Sodium is a semisynthetic echinocandin antifungal agent derived from the fermentation product of *Coleophoma empetri*. This product is a critical active pharmaceutical ingredient (API) valued for its potent fungicidal activity against a broad spectrum of *Candida* and *Aspergillus* species. It is primarily utilized by pharmaceutical manufacturers in the development and production of injectable antifungal medications for the treatment of serious systemic fungal infections.

Application

• Pharmaceutical API: As the active ingredient in sterile injectable formulations for the treatment of invasive candidiasis, esophageal candidiasis, and prophylaxis of *Candida* infections in hematopoietic stem cell transplant recipients.
• Hospital-Use Antifungals: For the compounding and manufacturing of ready-to-use intravenous solutions and lyophilized powders for reconstitution used in clinical settings.
• Drug Development: Serves as a reference standard and key intermediate in the research and development of new antifungal therapies and combination treatments.
• Generic Drug Manufacturing: A critical component for companies producing bioequivalent versions of branded micafungin sodium products for global markets.

Basic Information

Product Name	Micafungin Sodium
CAS No.	208538-73-2
Molecular Formula	C56H70N9NaO23S
Molecular Weight	1292.26 g/mol
Synonyms	Micafungin Sodium Salt; FK-463; Mycamine; (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-3-hydroxy-L-ornithyl-trans-4-hydroxy-L-proline Sodium Salt; FR-901379 Sodium; NK-3201; NK3201
EINECS	Contact for details

Quality Control

Our Micafungin Sodium is manufactured under strict cGMP conditions, ensuring the highest standards of purity and consistency for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, potency, and specified impurities. We adhere to stringent in-house specifications aligned with major pharmacopeial standards to guarantee product safety and efficacy.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C) or as specified. This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to prevent degradation and maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 10.0%
pH (1% Solution)	6.0 - 8.0
Specific Rotation	+40.0° to +50.0°
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Bacterial Endotoxins	< 0.25 EU/mg
Sterility (where applicable)	Sterile

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