Description

Micafungin Impurity 10 is a specified impurity and degradation product of the antifungal pharmaceutical agent Micafungin. 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 for method validation, stability studies, and ensuring the purity and safety of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Micafungin drug substance and finished products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to detect and quantify impurities.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Micafungin and to establish stability-indicating methods.
• Quality Control and Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in the quality control testing of active pharmaceutical ingredients (APIs).
• Regulatory Submissions: Provides necessary data on impurity profiles for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the fate of this impurity in biological systems.

Basic Information

Product Name	Micafungin Impurity 10
CAS No.	539823-82-0
Molecular Formula	C56H70N9O23S
Molecular Weight	1293.28 g/mol
Synonyms	(5-[(1S,2S)-2-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-3-[(2R,3R,4S,5R,6R)-4-Amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-11,20,21,25-tetrahydroxy-15-[(1R,2R)-1-hydroxy-1-(4-hydroxyphenyl)propan-2-yl]-18-[(4-{5-[4-(pentyloxy)phenyl]-1,2-oxazol-3-yl}benzoyl)amino]-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.09,13]heptacosan-6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenyl)hydrogen sulfate; FK463 Impurity 10; Mycamine Impurity 10; Micafungin Related Compound 10.
EINECS	Contact for details

Quality Control

Every batch of Micafungin Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
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 guidelines

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