Description

Rifabutin CAS NO 72559-06-9 is a semi-synthetic ansamycin antibiotic derived from rifamycin S. This compound is critical for its potent antibacterial activity, particularly against mycobacteria. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers for the formulation of anti-tuberculosis and anti-MAC (Mycobacterium avium complex) medications. Its role is vital in addressing drug-resistant bacterial infections in clinical settings.

Application

• Primary API in the manufacture of oral capsules for the treatment of pulmonary tuberculosis.
• Key component in combination therapies for preventing and treating Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
• Used in clinical research for investigating new applications against other persistent bacterial infections.
• Essential material for compounding pharmacies preparing specialized dosage forms.
• Serves as a reference standard in analytical laboratories for quality control and method development.
• Used in preclinical studies to evaluate pharmacokinetics and novel drug delivery systems.

Basic Information

Product Name	Rifabutin
CAS No.	72559-06-9
Molecular Formula	C46H62N4O11
Molecular Weight	847.00 g/mol
Synonyms	Ansamycin; LM-427; Mycobutin; Rifabutinum; Rifabutina; (9S,12E,14S,15R,16S,17R,18R,19R,20S,21S,22E,24Z)-6,16,18,20-Tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,10-dioxo-3,26-dioxa-11-azatetracyclo[25.3.1.14,7.05,27]hentriaconta-12,22,24,27,29,31-hexaene-23-carboxamide
EINECS	Contact for details

Quality Control

Our Rifabutin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity pharmacopeial standards, including identification, assay, impurity profile, and residual solvent analysis. Certificates of Analysis (COA) are provided with each shipment, detailing compliance with relevant specifications. We support audits and can provide documentation for regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and potency. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	Reddish-violet crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13 requirements

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.