Rifabutin Impurity Standards
Rifabutin Impurity Standards
Rifabutin impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Rifabutin-related impurities during analytical method development, method validation, and regulatory filing. As a rifamycin antibiotic, Rifabutin 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 Rifabutin 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.
RIFABUTIN EP IMPURITY A
Chemical Name: 1-(2-Methylpropyl)piperidin-4-one
CAS No:
72544-16-2
Molecular Formula: C9H17NO
Molecular Weight: 155.24
CAT No:
ALL-RIFA-1943
Keywords: PHARMACEUTICAL IMPURITIES LIKE RIFABUTIN...
Inventory Status:IN STOCK-385-69
RIFABUTIN EP IMPURITY B
Chemical Name: 3-Amino-1,4-dideoxy-1,4-dihydro-1,4-diox...
CAS No:
51756-80-0
Molecular Formula: C37H46N2O12
Molecular Weight: 710.79
CAT No:
ALL-R03889
Keywords: PHARMACEUTICAL IMPURITIES LIKE RIFABUTIN...
Inventory Status:IN STOCK-386-69
RIFABUTIN EP IMPURITY C
Chemical Name: 21,31-Didehydrorifabutin
CAS No:
2241829-23-0
Molecular Formula: C46H60N4O11
Molecular Weight: 844.99
CAT No:
ALL-RIFA-1945
Keywords: PHARMACEUTICAL IMPURITIES LIKE RIFABUTIN...
Inventory Status:IN STOCK-387-69
RIFABUTIN EP IMPURITY D
Chemical Name: 3-Amino-4-imidorifamycin S
CAS No:
62041-01-4
Molecular Formula: C37H47N3O11
Molecular Weight: 709.78
CAT No:
ALL-RIFA-1946
Keywords: PHARMACEUTICAL IMPURITIES LIKE RIFABUTIN...
Inventory Status:IN STOCK-388-69
RIFABUTIN EP IMPURITY E
Chemical Name: 25-O-Deacetyl Rifabutin ;16-Deacetylrifa...
CAS No:
100324-63-8
Molecular Formula: C44H60N4O10
Molecular Weight: 804.97
CAT No:
ALL-RIFA-1947
Keywords: RIFABUTIN IMPURITY, RIFABUTIN EP IMPURIT...
Inventory Status:IN STOCK-389-69
RIFABUTIN N-OXIDE
Chemical Name: Spiro[9,4-(epoxypentadeca[1,11,13]trieni...
CAS No:
645406-37-7
Molecular Formula: C46 H62 N4 O12
Molecular Weight: 863
CAT No:
ALL-RIFA-1948
Keywords: RIFABUTIN N-OXIDE
Inventory Status:IN STOCK-390-69
Key Rifabutin impurity variants available
- Rifabutin EP Impurity B (3 — Amino Rifamycin S)-CAS 51756-80-0
- Rifabutin EP Impurity D
- Rifabutin EP Impurity E (25 — O-Desacetyl Rifabutin)-CAS 100324-63-8
- Rifabutin EP Impurity E — d7 (deuterium-labeled analog)-CAS 1294503-48-2
- Rifabutin — related process and degradation impurities, characterized to support both EP and USP method requirements
Allmpus Capability for This Drug Family
Allmpus Laboratories Private Limited, based in India, specializes in the design, research, and synthesis of API-related compounds, process impurities, and metabolites across a range of therapeutic drug families, including the rifamycin class. Our synthesis and isolation/purification workflows are developed with a focus on cost-effective, scalable production without compromising analytical rigor. Each impurity standard is fully characterized and supplied with supporting data appropriate for use in method development, method validation, and genotoxic impurity studies. Our reference materials are produced to meet the documentation and traceability expectations of regulatory agencies, supporting clients through ANDA and DMF filing processes.
Frequently Asked Questions
1. What is the difference between an EP impurity designation and a USP related compound?
EP impurities are named and numbered according to the European Pharmacopoeia monograph for a given API, while USP designates equivalent or related substances under its own related-compound nomenclature. Both refer to characterized substances used as reference standards for compendial and in-house analytical methods, though naming conventions and structural coverage can differ between the two pharmacopoeias.
2. Are Allmpus Rifabutin impurity standards suitable for regulatory filings?
Yes. These standards are supplied with characterization data suitable for supporting analytical method validation, stability studies, and genotoxic impurity assessments referenced in ANDA and DMF submissions. Specific documentation packages should be confirmed with our technical team based on the intended regulatory use.
3. Are these impurity standards intended for human use?
No. Rifabutin impurity reference standards are intended solely for analytical and research purposes, including method development and quality control testing, and are not intended for human or veterinary administration.