Rifaximin Impurity Standards
Rifaximin Impurity Standards
Rifaximin impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Rifaximin-related impurities during analytical method development, method validation, and regulatory filing. As a rifamycin antibiotic, Rifaximin 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 Rifaximin 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.
RIFAXIMIN 11-DESMETHYL IMPURITY
Chemical Name: 4-Deoxy-pyridol[1',2'-1,2]imid...
CAS No:
1316302-12-1
Molecular Formula: C42H49N3O11
Molecular Weight: 771.85
CAT No:
ALL-RIF-1949
Keywords: SMILES string - O=C1C(C2=C3C(O)=C(NC(/C(...
Inventory Status:IN STOCK
RIFAXIMIN DESACETYL IMPURITY
Chemical Name: 5,6,21,23,25-Pentahydroxy-27-methoxy-2,4...
CAS No:
80621-88-1
Molecular Formula: C41H49N3O10
Molecular Weight: 743.84
CAT No:
ALL-RIF-1950
Keywords: SMILES string - O=C1C(C2=C3C(O)=C(NC(/C(...
Inventory Status:IN STOCK-391-71
RIFAXIMIN EP IMPURITY A
Chemical Name: 4-Methylpyridin-2-amine
CAS No:
695-34-1
Molecular Formula: C6H8N2
Molecular Weight: 108.14
CAT No:
ALL-RIF-1951
Keywords: SMILES string - NC1=NC=CC(C)=C1
Inventory Status:IN STOCK-392-71
RIFAXIMIN EP IMPURITY B
Chemical Name: 4-O-Carboxymethyl Rifamycin ;[(1,2-Dihyd...
CAS No:
13929-35-6
Molecular Formula: C39H49NO14
Molecular Weight: 755.8
CAT No:
ALL-RIF-B
Keywords: SMILES string - [H][C@@](OC(C)=O)([C@@H]...
Inventory Status:IN STOCK-393-71
RIFAXIMIN EP IMPURITY C
Chemical Name: 5,6,9,17,19,21-Hexahydroxy-23-methoxy-2,...
CAS No:
6998-60-3 (base) ; 14897-39-3 (Na salt)
Molecular Formula: C37H46NNaO12
Molecular Weight: 719.75
CAT No:
ALL-RIF-1953
Keywords: SMILES string - CC1=C(O2)C3=C4C(C(O)=C(N...
Inventory Status:IN STOCK-394-71
RIFAXIMIN EP IMPURITY D
Chemical Name: (2S,16Z,18E,20R,21S,22R,23R,24R,25S,26R,...
CAS No:
NA
Molecular Formula: C43H49N3O12
Molecular Weight: 799.86
CAT No:
ALL-R06943
Keywords: SMILES string - CC1=CC2=NC3=C(C(NC(/C(C)...
Inventory Status:UNDER DEVELOPMENT
RIFAXIMIN EP IMPURITY D & H
Chemical Name: (2S,16Z,18E,20R,21S,22R,23R,24R,25S,26R,...
CAS No:
N.A
Molecular Formula: C43H49N3O12 + C43H51N3O12
Molecular Weight: 799.86 + 801.88
CAT No:
ALL-R07090
Keywords: SMILES string - CC1=CC2=NC3=C(C(NC(/C(C)...
Inventory Status:IN STOCK
RIFAXIMIN EP IMPURITY E
Chemical Name: 1,4-Dideoxy-1,4-dihydro-1,4-dioxo-rifamy...
CAS No:
13553-79-2
Molecular Formula: C37H45NO12
Molecular Weight: 695.75
CAT No:
ALL-RIF-1955
Keywords: SMILES string - O=C1C2=C(C(C=C3NC(/C(C)=...
Inventory Status:IN STOCK-395-71
RIFAXIMIN EP IMPURITY F
Chemical Name: 4-O-(Carboxymethyl)-1-deoxy-1,4-dihydro-...
CAS No:
14487-05-9
Molecular Formula: C39H47NO14
Molecular Weight: 753.79
CAT No:
ALL-RIF-1956
Keywords: SMILES string - O=C1C(C(C(OC2=O)(OC2)C=C...
Inventory Status:IN STOCK-396-71
RIFAXIMIN EP IMPURITY G
Chemical Name: (2S,7Z,16Z,18E,20S,21S,22R,23R,24R,25S,2...
CAS No:
80621-76-7
Molecular Formula: C43H49N3O11
Molecular Weight: 783.86
CAT No:
ALL-RIF-G
Keywords: SMILES string - O=C1C(C(C2=C(/C3=N/C(/C(...
Inventory Status:IN STOCK-397-71
RIFAXIMIN EP IMPURITY H
Chemical Name: (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,...
CAS No:
1210022-90-4
Molecular Formula: C43H51N3O12
Molecular Weight: 801.88
CAT No:
ALL-R06792
Keywords: SMILES string - CC1=CC2=NC3=C(C(N4)=C(O)...
Inventory Status:UNDER DEVELOPMENT
RIFAXIMIN IMPURITY 1
Chemical Name: (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,...
CAS No:
1351775-04-6
Molecular Formula: C43H49N3O11
Molecular Weight: 783-86
CAT No:
ALL-R04478
Keywords: SMILES string - O=C([C@](O1)(O/C=C/[C@@H...
Inventory Status:IN STOCK-398-71
RIFAXIMIN IMPURITY 2
Chemical Name: (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,...
CAS No:
1351775-03-5
Molecular Formula: C43H49N3O11
Molecular Weight: 783-86
CAT No:
ALL-R04404
Keywords: SMILES string - O=C1C(C(C(C(N2C=C3)=C4NC...
Inventory Status:IN STOCK-399-71
Key Rifaximin impurity variants available
- Rifaximin EP Impurity A (2 — Amino-4-picoline)-CAS 695-34-1
- Rifaximin EP Impurity B (Rifamycin SV) — CAS 13929-35-6
- Rifaximin EP Impurity C — CAS 6998-60-3
- Rifaximin EP Impurity E (Rifamycin S) — CAS 13553-79-2
- Rifaximin EP Impurity H (16 — Desmethyl-16-(hydroxymethyl)rifaximin)-CAS 1210022-90-4
Allmpus Capability for This Drug Family
Allmpus Laboratories Private Limited, based in India, is engaged in the design, research, and cost-effective synthesis of API-related compounds, process impurities, and metabolites, including those associated with rifaximin and the broader rifamycin family. Our synthesis and isolation/purification techniques are developed to produce well-characterized impurity standards suitable for method development, method validation, and quality control applications. Reference materials are supplied with supporting documentation intended to meet the traceability and characterization expectations of regulatory agencies, assisting clients with ANDA and DMF filings as well as genotoxic impurity studies.
Frequently Asked Questions
1. Why does Rifaximin require monitoring of so many distinct impurity variants?
Rifaximin's synthesis from rifamycin SV involves multiple reaction and purification steps, each of which can introduce specific process-related impurities or leave behind synthetic intermediates. EP and USP monographs identify these individually so that each can be controlled within its own specified limit.
2. Are Rifaximin impurity standards from Allmpus suitable for structure elucidation work?
Reference standards are supplied with characterization data appropriate for identity confirmation and method development. Where a detailed structure elucidation report is required for a specific impurity, this should be confirmed with our technical team based on the compound and intended use.
3. Are these Rifaximin impurity standards intended for human use?
No. These standards are intended solely for analytical and research applications, including method development, validation, and quality control testing, and are not intended for human or veterinary administration.