Micafungin Impurity Standards
Micafungin Impurity Standards
Micafungin impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Micafungin-related impurities during analytical method development, method validation, and regulatory filing. As a echinocandin antifungal, Micafungin requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Micafungin impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.
DESMETHYL MICAFUNGIN
Chemical Name: Sodium 5-[(1S,2S)-2-{(2R,6S,9S,11R,12R,1...
CAS No:
1392514-03-2 (Na) 1392513-99-3 (free base)
Molecular Formula: C55H68N9O23S : Na
Molecular Weight: 1255.2 + 23.0 = 1278.2
CAT No:
ALL-M08640
Keywords: SMILES string - OC1=CC=C([C@H](O)[C@@H](...
Inventory Status:IN STOCK
Micafungin Impurity E / Deoxy Micafungin Impurity
Chemical Name: sodium 5-((1S,2S)-2-((2R,6S,9S,12R,14aS,...
CAS No:
1392514-06-5
Molecular Formula: C56H70N9NaO22S
Molecular Weight: 1276.26 g/mol
CAT No:
ALL-M08439
Keywords: SMILES string - O=S(OC1=CC([C@H](O)[C@H]...
Inventory Status:IN STOCK
MICAFUNGIN IMPURITY A / MICAFUNGIN OPEN RING ANALOG
Chemical Name: Sodium 5-[(1S,2S,3S)-4-({(2S,3R)-5-amino...
CAS No:
539823-82-0
Molecular Formula: C56H70N9NaO23S
Molecular Weight: 1292.26 g/mol
CAT No:
ALL-M07322
Keywords: SMILES string - [O-]S(OC1=CC([C@H](O)[C@...
Inventory Status:IN STOCK
MICAFUNGIN IMPURITY B/ MICAFUNGIN SERINE ANALOG
Chemical Name: 5-((1S,2S)-2-((2R,6S,9S,11R,12R,14aS,15S...
CAS No:
1392514-04-3
Molecular Formula: C55H69N9NaO23S
Molecular Weight: 1279.24
CAT No:
ALL-M07325
Keywords: SMILES string - CCCCCOC1=CC=C(C2=CC(C3=...
Inventory Status:IN STOCK
MICAFUNGIN IMPURITY D / O-DESULFO MICAFUNGIN
Chemical Name: N-((2R,6S,9S,11R,12R,14aS,15S,16S,20S,23...
CAS No:
539823-80-8
Molecular Formula: C56H71N9O20
Molecular Weight: 1190.21
CAT No:
ALL-M07326
Keywords: SMILES string - O=C(N[C@@H]1C(N[C@@H]([C...
Inventory Status:IN STOCK
MICAFUNGIN IMPURITY F / MICAFUNGIN SODIUM STEREOISOMER
Chemical Name: 5-((1S,2S)-2-((2R,6S,9S,11R,12R,14aS,15S...
CAS No:
1686155-92-9
Molecular Formula: C56H71N9NaO23S
Molecular Weight: 1293.26
CAT No:
ALL-M07324
Keywords: Micafungin Impurity F / Micafungin Sodiu...
Inventory Status:IN STOCK
MICAFUNGIN IMPURITY H / MICAFUNGIN EPIMER IMPURITY
Chemical Name: Sodium5-[(1S,2S)-2-{(2R,6S,9S,11R,12S,14...
CAS No:
1392514-05-4
Molecular Formula: C56H70N9NaO23S
Molecular Weight: 1292.26 g/mol
CAT No:
ALL-M07321
Keywords: SMILES string - OC1=CC=C([C@H](O)[C@@H](...
Inventory Status:IN STOCK
Micafungin Nucleus / FR-179642 / WF11899A Nucleus / FR-901379 Nucleus
Chemical Name: 5-((1S,2S)-2-((2R,6S,9S,11R,12R,14aS,15S...
CAS No:
168110-44-9
Molecular Formula: C35H52N8O20S
Molecular Weight: 936.9
CAT No:
ALL-MO0449
Keywords: SMILES string - O=C1N2[C@@](C(N[C@@H]([C...
Inventory Status:IN STOCK
Micafungin Side Chain Acid
Chemical Name: 4-(5-(4-(Pentyloxy)phenyl)isoxazol-3-yl)...
CAS No:
179162-55-1
Molecular Formula: C21H21NO4
Molecular Weight: 351.4
CAT No:
ALL-MO2551
Keywords: SMILES string - O=C(O)C1=CC=C(C2=NOC(C3...
Inventory Status:IN STOCK
Micafungin Side Chain Acid Benzotriazole Ester
Chemical Name: 4-(5-(4-(Pentyloxy)phenyl)isoxazol-3-yl)...
CAS No:
NA
Molecular Formula: C27H24N4O4
Molecular Weight: 468.5
CAT No:
ALL-MO2444
Keywords: SMILES string - O=C(C1=CC=C(C2=NOC(C3=CC...
Inventory Status:IN STOCK
Micafungin Side Chain Acid Methyl Ester
Chemical Name: 4-(5-(4-(Pentyloxy)phenyl)isoxazol-3-yl)...
CAS No:
179162-64-2
Molecular Formula: C22H23NO4
Molecular Weight: 365.42
CAT No:
ALL-MO2642
Keywords: SMILES string - O=C(C1=CC=C(C2=NOC(C3=CC...
Inventory Status:IN STOCK
Micafungin Sodium / Micafungin Acid Sodium Salt / FK463 (Sodium Salt)
Chemical Name: Sodium 5-((1S,2S)-2-((2R,6S,9S,11R,12R,1...
CAS No:
208538-73-2
Molecular Formula: C56H70N9NaO23S
Molecular Weight: 1269.3 : 23.0
CAT No:
ALL-MO8732
Keywords: SMILES string - OC1=C(OS(=O)([O-])=O)C=C...
Inventory Status:IN STOCK
Micafungin WF11899A Impurity / WF11899A (Acid) / FR-901379 (Acid)
Chemical Name: 5-(2-(20-(3-amino-1-hydroxy-3-oxopropyl)...
CAS No:
160335-87-5 ; 144371-88-0 ; 138328-74-2
Molecular Formula: C51H82N8O21S
Molecular Weight: 1175.3
CAT No:
ALL-MO5875
Keywords: SMILES string - CCCCCCCCCCCCCCCC(NC(CC(O...
Inventory Status:IN STOCK
Key Micafungin Impurity Variants
- Deoxy Micafungin (CAS 1392514 — 06-5)-a hydroxyl-deficient analogue arising from incomplete hydroxylation during synthesis, listed in the USP–NF monograph for Micafungin Sodium
- Desmethyl Micafungin (sodium salt) (CAS 1392514 — 03-2)-a demethylated process-related impurity, also referred to as Micafungin EP Impurity B, controlled under the USP monograph
- Micafungin Epimer Impurity (CAS 1392514 — 05-4)-a stereochemical epimer of the parent molecule, also known as Micafungin Impurity H, listed as a USP–NF related substance
- Micafungin Open — Ring Analog (sodium salt) (CAS 539823-82-0)-a hydrolytic ring-opened degradant relevant to stability and forced-degradation studies, included in the USP monograph
- Micafungin Serine Analog (CAS 1392514 — 04-3)-a side-chain analogue in which a residue is replaced by serine, listed as a USP–NF related substance
- Non — pharmacopeial process impurities and precursor-related compounds (such as the micafungin nucleus and side-chain acid fragments) are also available where relevant to synthetic route investigations.
Allmpus's Capability for This Drug Family
Allmpus Laboratories has developed synthetic and isolation capability across the micafungin structural family, including the drug substance itself, its nucleus and side-chain fragments, and its characterized process-related impurities. Given the structural complexity of echinocandin cyclic peptides, isolation of these closely related species requires preparative purification techniques capable of resolving single-atom or single-stereocenter differences. Each compound supplied by Allmpus is released with a Certificate of Analysis comprising ¹H NMR, ¹³C NMR, mass spectrometry, HPLC purity, IR, and TGA data, supporting customers' method validation, impurity qualification, and regulatory submission requirements. Allmpus's R&D and manufacturing operations, based in Maharashtra, India, support API manufacturers, generic injectable developers, and contract research organizations sourcing micafungin-related reference standards for QC testing and DMF/ANDA support work.
Frequently Asked Questions
Why does micafungin have USP-listed impurities when it is a complex fermentation-derived peptide?
Because micafungin undergoes both fermentation and downstream chemical modification, specific process-related impurities are consistently produced at trace levels, and the most significant of these have been characterized and incorporated into the USP–NF monograph as named related substances with defined limits.
What is the difference between Deoxy Micafungin and the Open-Ring Analog?
Deoxy Micafungin results from incomplete hydroxylation during synthesis, while the Open-Ring Analog is a hydrolytic degradation product formed by cleavage of the macrocyclic ring, making the two relevant to different stages of quality monitoring (process control versus stability testing).
Are micafungin precursor fragments, such as the nucleus or side-chain acid, the same as impurities?
Not exactly-these fragments represent synthetic intermediates or building blocks used in route-of-synthesis investigations and impurity origin studies, rather than impurities formally controlled in the finished drug substance specification.