Description

Micafungin Impurity H is a specified impurity of the antifungal pharmaceutical agent Micafungin Sodium. This compound is critical for analytical research and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of the final drug product. The availability of this well-characterized impurity standard is essential for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Micafungin Impurity H in Micafungin Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Utilized to track the formation and increase of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Research and Development: Aids in synthetic route optimization and process chemistry studies to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Micafungin Impurity H
CAS No.	1392514-05-4
Molecular Formula	C56H70N9O23S
Molecular Weight	1269.28 g/mol
Synonyms	(5-{[(6R,7R,8S)-8-{[(1S,2S)-2-[(1S,2S)-1,2-Dihydroxy-2-(4-hydroxy-3-sulfophenyl)ethyl]-2-hydroxy-1-methyl-2-(4-{[(5S)-5-[(1R,2R)-1,2-dihydroxy-2-(4-hydroxy-3-sulfophenyl)ethyl]-5-(hydroxymethyl)-2-oxooxazolidin-3-yl]phenyl}butyl)cyclopropyl]carbamoyl}-7-methoxy-2-[(1E,3E,5E,7E)-8-(4-methoxyphenyl)-2,6-dimethylocta-1,3,5,7-tetraen-1-yl]-5-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]carbamoyl}-1,3-thiazol-2-yl)guanidine; Micafungin Related Compound H; FK463 Impurity H; Mycamine Impurity H; (1S,2S)-2-[(1S,2S)-1,2-Dihydroxy-2-(4-hydroxy-3-sulfophenyl)ethyl]-2-hydroxy-1-methyl-2-(4-{[(5S)-5-[(1R,2R)-1,2-dihydroxy-2-(4-hydroxy-3-sulfophenyl)ethyl]-5-(hydroxymethyl)-2-oxooxazolidin-3-yl]phenyl}butyl)cyclopropanaminium Impurity H
EINECS	Contact for details

Quality Control

Our Micafungin Impurity H is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures material suitable for use as a pharmaceutical reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, consider storing at 2-8°C. The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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% w/w
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.