Fusidic Acid Impurity Standards
Fusidic Acid Impurity Standards
Fusidic Acid impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Fusidic Acid-related impurities during analytical method development, method validation, and regulatory filing. As a steroidal antibiotic, Fusidic Acid 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 Fusidic Acid 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.
DIETHANOLAMINE FUSIDATE
Chemical Name: 2,2'-Azanediylbis(ethan-1-ol) (Z)-2...
CAS No:
16391-75-6
Molecular Formula: C31H48O6 : C4H11NO2
Molecular Weight: 516.7 : 105.1
CAT No:
ALL-FUS-DIF
Keywords: SMILES string - O[C@]1([H])CC[C@@]2(C)[C...
Inventory Status:DELIVERY 3-4 WEEKS
FUSIDIC ACID
Chemical Name: ent-(17Z)-16α-(Acetyloxy)-3β,11β-dihy...
CAS No:
6990-06-3
Molecular Formula: C31H48O6
Molecular Weight: 516.71
CAT No:
ALL-FUS-FAA
Keywords: SMILES string - O[C@]1([H])CC[C@@]2(C)[C...
Inventory Status:3-4 WEEKS
FUSIDIC ACID 3,11-DIKETO IMPURITY
Chemical Name: ent-(17Z)-16α-(Acetyloxy)-3,11-dioxo-4...
CAS No:
3482-38-0
Molecular Formula: C31H44O6
Molecular Weight: 512.68
CAT No:
ALL-FUS-DIK
Keywords: SMILES string - C[C@@]([C@](C1=O)([H])[C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY A
Chemical Name: ent-(24SR,17Z)-16α-(Acetyloxy)-3β,11β...
CAS No:
80445-74-5
Molecular Formula: C31H50O8
Molecular Weight: 550.72
CAT No:
ALL-FUS-EPA
Keywords: SMILES string - O[C@]1([H])CC[C@@]2(C)[C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY B
Chemical Name: Ent-(17Z)-3β,11β-Dihydroxy-17-[(6SR)-6...
CAS No:
N.A.
Molecular Formula: C31H48O7
Molecular Weight: 532.71
CAT No:
ALL-FUS-EPB
Keywords: SMILES string - C[C@@]1(C[C@]/2([H])OC(C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY C
Chemical Name: Ent-(17Z)-3β,11β-Dihydroxy-17-[(6S)-6-...
CAS No:
NA
Molecular Formula: C31H48O7
Molecular Weight: 532.71
CAT No:
ALL-FUS-EPC
Keywords: SMILES string - C[C@@]1(C[C@]/2([H])OC(C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY D
Chemical Name: Ent-(17Z)-3β,11β-Dihydroxy-17-[(6R)-6-...
CAS No:
3054708-76-5
Molecular Formula: C31H48O7
Molecular Weight: 532.71
CAT No:
ALL-FUS-EPD
Keywords: SMILES string - C[C@@]1(C[C@]/2([H])OC(C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY E
Chemical Name: Ent-(17Z,24EZ)-16α-(Acetyloxy)-3β,11β...
CAS No:
2802408-15-5
Molecular Formula: C31H48O7
Molecular Weight: 532.71
CAT No:
ALL-FUS-EPE
Keywords: SMILES string - C[C@@]1(C[C@]/2([H])OC(C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY F
Chemical Name: Ent-(17Z,24EZ)-16alpha-(acetyloxy)-3beta...
CAS No:
1415035-94-7
Molecular Formula: C31H46O7
Molecular Weight: 530.7
CAT No:
ALL-FUS-EPF
Keywords: SMILES string -C[C@@]([C@](C[C@H]1O)([H]...
Inventory Status:DELIVERY 3-4 WEEKS
FUSIDIC ACID EP IMPURITY G
Chemical Name: ent-(17Z)-16α-(Acetyloxy)-11β-hydroxy-...
CAS No:
4680-37-9
Molecular Formula: C31H46O6
Molecular Weight: 514.69
CAT No:
ALL-FUS-EPG
Keywords: SMILES string - C[C@@]([C@]([C@H](O)C1)(...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY H
Chemical Name: ent-(17Z)-16α-(Acetyloxy)-3β-hydroxy-4...
CAS No:
16711-91-4
Molecular Formula: C31H46O6
Molecular Weight: 514.69
CAT No:
ALL-FUS-EPH
Keywords: SMILES string - C[C@@]([C@@]1([H])C2)(C[...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY I
Chemical Name: ent-(17Z)-3β,11β,16β-trihydroxy-4β,8...
CAS No:
5951-83-7
Molecular Formula: C29H46O5
Molecular Weight: 474.67
CAT No:
ALL-FUS-EPI
Keywords: SMILES string - C[C@@]([C@]([C@H](O)C1)(...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY J
Chemical Name: Ent-(17Z)-3?,11?-dihydroxy-4?,8,14-trim...
CAS No:
13011-12-6
Molecular Formula: C29H44O4
Molecular Weight: 456.7
CAT No:
ALL-FUS-EPJ
Keywords: SMILES string - O=C1C(CC/C=C(C)/C)=C2[C@...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY K
Chemical Name: Ent-(17Z)-3beta,11beta-dihydroxy-4beta,8...
CAS No:
4701-54-6
Molecular Formula: C29H44O4
Molecular Weight: 456.7
CAT No:
ALL-FUS-EPK
Keywords: SMILES string -C[C@]([C@]([C@@]1([H])C2)...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY L
Chemical Name: ent-(17Z)-16α-(Acetyloxy)-3β-hydroxy-4...
CAS No:
74048-41-2
Molecular Formula: C31H46O5
Molecular Weight: 498.69
CAT No:
ALL-FUS-EPL
Keywords: SMILES string - C[C@@]([C@]1([H])/C2=C(C...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID EP IMPURITY M
Chemical Name: Ent-(17Z)-16alpha-(acetyloxy)-3beta-hydr...
CAS No:
1013937-16-0
Molecular Formula: C31H48O5
Molecular Weight: 500.7
CAT No:
ALL-FUS-EPM
Keywords: SMILES string - C[C@@]([C@](CC1)([H])/C2...
Inventory Status:DELIVERY 3-4 WEEKS
FUSIDIC ACID EP IMPURITY O
Chemical Name: ent-(17Z)-3β,11β,16α-trihydroxy-4β,8...
CAS No:
55601-53-1
Molecular Formula: C29H45NaO5
Molecular Weight: 496.65
CAT No:
ALL-FUS-EPO
Keywords: SMILES string - C/C(C)=C\CC/C(C([O-])=O)...
Inventory Status:DELIVERY IMMEDIATE
FUSIDIC ACID IMPURITY N
Chemical Name: (Z)-6-Methyl-2-((3R,4S,5S,8S,9S,10S,11R,...
CAS No:
13090-91-0
Molecular Formula: C29H46O5
Molecular Weight: 474.7
CAT No:
ALL-FUS-EPN
Keywords: SMILES string -O=C(O)/C(CC/C=C(C)\C)=C1[...
Inventory Status:DELIVERY 3-4 WEEKS
FUSIDIC ACID SODIUM SALT
Chemical Name: 2-[(1S,2S,5R,6S,7S,10S,11S,13S,14Z,15R,1...
CAS No:
751-94-0
Molecular Formula: C31H47NaO6
Molecular Weight: 538.69
CAT No:
ALL-FUS-FAS
Keywords: SMILES string -O[C@]1([H])CC[C@@]2(C)[C@...
Inventory Status:3-4 WEEKS
Key Impurity Variants Available
- Fusidic Acid EP Impurity A — CAS 80445-74-5, a related steroidal substance included in the EP related-substances test
- Fusidic Acid EP Impurity B — a process-related substance characterized for use in EP impurity profiling (C31H48O7)
- Fusidic Acid EP Impurity D — CAS 3054708-76-5, the 24,25-dihydro-24,25-dihydroxy lactone derivative of fusidic acid
- Fusidic Acid EP Impurity G (3 — Keto Fusidic Acid)-CAS 4680-37-9, an oxidation-related degradation product
- Fusidic Acid EP Impurity M (11 — Deoxyfusidic Acid)-CAS 1013937-16-0, a deoxygenated structural analog listed in the EP monograph
Allmpus Capability for This Drug Family
Fusidic acid's related substances are structurally close steroidal analogs that differ from the parent molecule and from each other by small changes in oxidation state, hydroxylation, or side-chain saturation, which places significant demands on both synthesis and chromatographic separation during characterization. Allmpus Laboratories' analytical and synthetic chemistry teams operate within R&D and manufacturing facilities accredited by USFDA, EU GMP, EDQM, KFDA, and COFEPRIS, and are equipped to isolate, synthesize, and characterize steroid-class impurities of this type. Standards are intended to be supplied with supporting analytical data-HPLC purity, NMR, and mass spectral confirmation-for direct use in method development, forced-degradation studies, and DMF or ANDA documentation. Where an EP-listed fusidic acid impurity is not currently held in inventory, our teams can undertake custom synthesis or isolation on request, including scale-up for extended stability programs.
Frequently Asked Questions
What documentation accompanies Allmpus fusidic acid impurity standards?
Standards are intended to be supplied with a Certificate of Analysis and supporting structural data, typically HPLC purity and spectroscopic confirmation, suitable for method validation and regulatory submissions.
Can Allmpus produce a fusidic acid-related substance that isn't currently listed?
Yes. Our synthetic and analytical chemistry teams undertake custom synthesis and isolation of steroidal-class impurities, including oxidation and deoxygenation-related variants, on a case-by-case basis.
Are these standards suitable for use directly in fusidic acid drug products?
No. Allmpus impurity standards are supplied strictly for laboratory, research, and analytical use-including method development and stability-indicating assay validation-and are not intended for human consumption or clinical administration.