Description

Ethambutol Dihydrochloride is a critical pharmaceutical active ingredient primarily used as a first-line antituberculosis agent. Its core value lies in its bacteriostatic activity against *Mycobacterium tuberculosis*, making it essential for combination therapy regimens to combat tuberculosis. This compound is a key raw material for pharmaceutical manufacturers producing finished dosage forms such as tablets and capsules. Global health organizations and pharmaceutical companies rely on a consistent supply of high-purity Ethambutol Dihydrochloride to support essential TB treatment programs worldwide.

Application

• Pharmaceutical Active Ingredient: Primary use as a key component in first-line antituberculosis (TB) drug formulations.
• Tablet and Capsule Manufacturing: Direct compression or granulation for solid oral dosage forms in combination therapies.
• Research & Development: Used in pharmacological studies, stability testing, and the development of new TB treatment protocols.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical laboratories.
• Veterinary Pharmaceuticals: Potential application in treating mycobacterial infections in animals.
• Intermediate Synthesis: May be used in the chemical synthesis of related ethambutol salts or derivatives.

Basic Information

Product Name	Ethambutol Dihydrochloride
CAS No.	1070-11-7
Molecular Formula	C10H24N2O2·2HCl
Molecular Weight	277.23 g/mol
Synonyms	(+)-Ethambutol Dihydrochloride; (S,S)-Ethambutol Dihydrochloride; EMB Dihydrochloride; Etambutol Dihydrochloride; Myambutol Dihydrochloride; (2S,2'S)-2,2'-(Ethane-1,2-diyldiimino)dibutan-1-ol dihydrochloride; Dexambutol Dihydrochloride; (+)-N,N'-Bis(1-hydroxymethylpropyl)ethylenediamine Dihydrochloride
EINECS	213-974-8

Quality Control

Our Ethambutol Dihydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets stringent specifications, including identity, purity, and impurity profiles. Certificates of Analysis (COA) are provided with each batch, detailing results from tests such as HPLC assay, chiral purity, and residual solvent analysis. We can supply material compliant with various pharmacopeial standards, including USP and EP monographs, upon request.

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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Chiral Purity (Enantiomeric Excess)	≥ 99.0%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Enumeration	Meets USP/EP criteria

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