Description

Ethambutol is a synthetic, bacteriostatic antimycobacterial agent primarily used in the treatment of tuberculosis. Its core value proposition lies in its specific activity against *Mycobacterium tuberculosis*, making it a critical first-line component in combination therapy to prevent drug resistance. This pharmaceutical active ingredient is essential for manufacturers of anti-tuberculosis medications, including tablets and fixed-dose combinations, serving global public health initiatives and pharmaceutical supply chains.

Application

• First-line Tuberculosis Treatment: A key component in combination therapy regimens (e.g., with isoniazid, rifampicin, and pyrazinamide) for active pulmonary tuberculosis.
• Pharmaceutical Formulation: Used as the active pharmaceutical ingredient (API) in the production of oral solid dosage forms, primarily film-coated or uncoated tablets.
• Drug-Resistant TB Management: Employed in certain regimens for the management of multidrug-resistant tuberculosis (MDR-TB), as per WHO treatment guidelines.
• Mycobacterial Infection Control: Used in the treatment of infections caused by other mycobacteria, such as *Mycobacterium avium* complex (MAC).
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for treating mycobacterial infections in animals.
• Reference Standard: Serves as a chemical reference standard in analytical laboratories for quality control and method development.

Basic Information

Product Name	Ethambutol
CAS No.	74-55-5
Molecular Formula	C10H24N2O2
Molecular Weight	204.31 g/mol
Synonyms	(+)-Ethambutol; (S,S)-Ethambutol; EMB; Etambutol; Myambutol®; Dexambutol; 2,2'-(Ethylenediimino)di-1-butanol; (2S,2'S)-2,2'-(Ethane-1,2-diyldiimino)dibutan-1-ol
EINECS	200-810-6

Quality Control

Our Ethambutol is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and BP. Each batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets the required specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Specific Rotation	+6.0° to +7.0°
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Microbial Enumeration	Meets EP/USP requirements

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