Description

Ethambutol Ep Impurity B Dihydrochloride is a high-purity chemical reference standard critical for pharmaceutical analysis and quality control. This compound serves as a specified impurity in the manufacturing and testing of the anti-tuberculosis drug Ethambutol, ensuring compliance with stringent pharmacopeial monographs. It is essential for analytical laboratories, quality assurance departments, and R&D teams in the pharmaceutical industry involved in method development, validation, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Ethambutol impurities as per EP, USP, and other pharmacopeias.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in active pharmaceutical ingredient (API) batches.
• Quality Control & Assurance (QC/QA): Used in routine testing of Ethambutol API and finished drug products to ensure they meet specified purity limits and regulatory requirements.
• Stability Studies: Employed to track the formation of degradation products in Ethambutol formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for Ethambutol.

Basic Information

Product Name	Ethambutol Ep Impurity B Dihydrochloride
CAS No.	32454-69-6
Molecular Formula	C10H26N2O2 · 2HCl
Molecular Weight	277.25 g/mol
Synonyms	(2S,2'S)-2,2'-(Ethane-1,2-diyldiimino)dibutan-1-ol dihydrochloride; (S,S)-Ethambutol Impurity B Dihydrochloride; EMB Impurity B HCl; (2S,2'S)-Ethambutol Dihydrochloride Impurity B; (+)-Ethambutol Related Compound B; (S,S)-1,2-Bis(2-aminobutan-1-yloxy)ethane dihydrochloride; (S,S)-N,N'-Bis(1-hydroxybutan-2-yl)ethylenediamine dihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Ethambutol Ep Impurity B Dihydrochloride is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards (EP, USP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques (HPLC, NMR, MS) is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	+12.5° to +13.5° (c=1 in H2O)

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