Description

Ethambutol Hydrochloride is a critical second-line antitubercular agent, specifically formulated as the hydrochloride salt of ethambutol for enhanced stability and bioavailability. Its primary value lies in its targeted bacteriostatic action against actively growing *Mycobacterium tuberculosis*, making it an essential component of combination therapy regimens to combat drug-resistant strains. This high-purity pharmaceutical intermediate is indispensable for manufacturers in the global pharmaceutical industry engaged in the production of anti-tuberculosis medications, as well as for research institutions developing new therapeutic formulations.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the key active component in the manufacture of finished dosage forms for the treatment of tuberculosis.
• Combination Therapy Formulations: Used in fixed-dose combination (FDC) drugs alongside other antitubercular agents like isoniazid, rifampicin, and pyrazinamide.
• Drug-Resistant TB Treatment: A cornerstone in second-line treatment protocols for multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB) tuberculosis.
• Pharmaceutical Research & Development: Serves as a reference standard and starting material in R&D for novel TB drug delivery systems and new combination therapies.
• Veterinary Pharmaceuticals: Potential application in the treatment of mycobacterial infections in animals.

Basic Information

Product Name	Ethambutol Hydrochloride
CAS No.	134566-79-3
Molecular Formula	C10H24N2O2·2HCl
Molecular Weight	277.23 g/mol
Synonyms	(+)-Ethambutol Dihydrochloride; EMB HCl; (S,S)-Ethambutol Dihydrochloride; (2S,2'S)-2,2'-(Ethane-1,2-diyldiimino)dibutan-1-ol dihydrochloride; Dexambutol Hydrochloride; Etambutol Hydrochloride; Myambutol Hydrochloride; SQ-10219 Hydrochloride
EINECS	Contact for details

Quality Control

Our Ethambutol Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, with potential alignment to pharmacopeial monographs such as USP, EP, or BP. A detailed Certificate of Analysis (COA) is provided with each batch, documenting critical parameters including assay, optical rotation, related substances, residual solvents, and microbiological quality.

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). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Specific Optical Rotation	+6.0° to +7.0° (c=1 in H2O)
Related Substances (HPLC)	Total impurities ≤ 1.0%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Conforms to EP/USP limits

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