Mupirocin Impurity Standards
Mupirocin Impurity Standards
Mupirocin impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Mupirocin-related impurities during analytical method development, method validation, and regulatory filing. As a topical antibiotic, Mupirocin 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 Mupirocin 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.
MUPIROCIN CALCIUM AND MUPIROCIN CALCIUM DIHYDRATE
Chemical Name: Calcium bis[9-[[(2E)-4-[(2S,3R,4R,5S)-3,...
CAS No:
115074-43-6
Molecular Formula: C26H43O9 : Ca : 2(H2O)
Molecular Weight: 499.6 : 40.1 : 2(36.5)
CAT No:
ALL-MUP-2
Keywords: SMILES string - O=C([O-])CCCCCCCCOC(/C=...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY A | PSEUDOMONIC ACID B
Chemical Name: 9-[[(2E)-4-[(2S,3R,4R,5R)-3,4,5-trihydro...
CAS No:
40980-51-6
Molecular Formula: C26H44O10
Molecular Weight: 516.62
CAT No:
ALL-M07312
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY B | PSEUDOMONIC ACID C
Chemical Name: 9-[[(2E)-4-[(2S,3R,4R,5S)-3,4-Dihydroxy-...
CAS No:
71980-98-8
Molecular Formula: C26H44O8
Molecular Weight: 484.62
CAT No:
ALL-M07313
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY C | PSEUDOMONIC ACID D
Chemical Name: (4E)-9-[[(2E)-4-[(2S,3R,4R,5S)-3,4-dihyd...
CAS No:
85178-60-5 (Sodium Salt) ; 85248-93-7 (acid)
Molecular Formula: C26H41NaO9
Molecular Weight: 520.59
CAT No:
ALL-M07314
Keywords: SMILES string - O=C(O)CC/C=C/CCCCOC(/C=...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY D | MUPIROCIN FURONYL ANALOG
Chemical Name: 9-[[(2E)-4-[(2R,3aS,6S,7S)-2-[(2S,3S)-1,...
CAS No:
116182-43-5 (Sodium Salt) ; 71087-97-3 (acid)
Molecular Formula: C26H43NaO9
Molecular Weight: 522.6
CAT No:
ALL-M07315
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY E | MUPIROCIN PYRANYL ANALOG
Chemical Name: 9-[[(2E)-4-[(2R,3RS,4aS,7S,8S,8aR)-3,8-d...
CAS No:
NA
Molecular Formula: C26H43NaO9
Molecular Weight: 523.61
CAT No:
ALL-M07316
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY F | PSEUDOMONIC ACID N
Chemical Name: 7-[[(2E)-4-[(2S,3R,4R,5S)-3,4-dihydroxy-...
CAS No:
167842-64-0
Molecular Formula: C24H40O9
Molecular Weight: 472.57
CAT No:
ALL-M07317
Keywords: SMILES string - O=C(O)CCCCCCOC(/C=C(C)/...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY G
Chemical Name: 9-[[(2E)-4-[(2S,3R,4R,5S)-5-(2-chloro-3,...
CAS No:
NA
Molecular Formula: C26H45ClO9
Molecular Weight: 537.08
CAT No:
ALL-M07318
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY H
Chemical Name: 99-[[(2E)-4-[(2S,3R,4R,5S)-5-(3-chloro-2...
CAS No:
NA
Molecular Formula: C26H45ClO9
Molecular Weight: 537.08
CAT No:
ALL-M07319
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
MUPIROCIN EP IMPURITY I
Chemical Name: 9-[[(2E)-4-[(2S,3R,4R,5S)-3,4-dihydroxy-...
CAS No:
NA
Molecular Formula: C26H44O9
Molecular Weight: 500.62
CAT No:
ALL-M07320
Keywords: SMILES string - O=C(O)CCCCCCCCOC(/C=C(C...
Inventory Status:DELIVERY IMMEDIATE
Key Mupirocin Impurity Variants
- Mupirocin EP Impurity A (Pseudomonic acid B, CAS 40980 — 51-6)-an epoxide-containing congener formed during fermentation, controlled as a specified impurity in the Ph. Eur. monograph
- Mupirocin EP Impurity B (Pseudomonic acid C, CAS 71980 — 98-8)-a related fermentation congener lacking the epoxide seen in Impurity A, also available as its sodium salt
- Mupirocin EP Impurity D (Mupirocin Furonyl Analogue / USP Impurity 1, CAS 71087 — 97-3)-a furanose ring-modified analogue used to confirm resolution from the main peak
- Mupirocin EP Impurity E (Mupirocin Pyranyl Analogue / USP Impurity 2, CAS 71087 — 96-2)-a pyranose ring-modified analogue structurally close to mupirocin
- Mupirocin EP Impurity F (Pseudomonic acid N/F, CAS 167842 — 64-0)-a shorter-chain heptanoic acid ester analogue of the main compound
- Sodium and calcium salt forms of several of these impurities are also available where relevant to the mupirocin calcium drug substance monograph.
Allmpus's Capability for This Drug Family
Allmpus Laboratories manufactures and isolates mupirocin-related impurities using preparative chromatographic separation techniques suited to closely related fermentation congeners, where small structural differences in ring configuration or side-chain length must be resolved and confirmed. Each impurity 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 documentation needs. Allmpus's R&D and manufacturing operations, based in Maharashtra, India, are structured to support API manufacturers, generic drug developers, and contract research organizations that require pharmacopeial and non-pharmacopeial mupirocin impurities for QC testing, ANDA/DMF filings, and stability program support.
Frequently Asked Questions
Why does mupirocin have so many structurally similar impurities?
Mupirocin is produced by fermentation, and the biosynthetic pathway naturally generates several related pseudomonic acid congeners alongside the main component; these are separated during purification but can remain as trace related substances that must be monitored.
What is the difference between Mupirocin EP Impurity D and Impurity E?
Impurity D (furonyl analogue) and Impurity E (pyranyl analogue) differ in the size of the oxygen-containing ring in the molecule-a furanose versus a pyranose ring-which affects their retention behavior in reversed-phase HPLC methods.
Are mupirocin calcium impurities different from mupirocin impurities?
Some impurities are shared between the two drug substances, but mupirocin calcium has its own EP monograph and can require sodium salt forms of certain impurities (e.g., Impurity B sodium salt) for accurate reference standard matching.