Description

Ethambutol Related Compound A (15 Mg) ((2R,2'S)-2,2'-[Ethane-1,2-Diylbis(Azanediyl)]Dibutan-1-Ol) is a high-purity analytical reference standard, essential for ensuring the quality and safety of pharmaceutical products. This compound is critical for the accurate identification and quantification of impurities in Ethambutol formulations, a key first-line drug for tuberculosis treatment. It is primarily used by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in drug development and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Ethambutol active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Enables routine batch testing in pharmaceutical QC laboratories to ensure products meet stringent pharmacopeial specifications (e.g., USP, EP, BP) for impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive proof of impurity characterization and control strategies for drug master files.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ethambutol to monitor the formation of related substances over time and under various stress conditions.
• Research & Development: Used in academic and industrial R&D settings to study the metabolism, degradation pathways, and synthesis of Ethambutol and its analogs.

Basic Information

Product Name	Ethambutol Related Compound A (15 Mg) ((2R,2'S)-2,2'-[Ethane-1,2-Diylbis(Azanediyl)]Dibutan-1-Ol)
CAS No.	10054-06-5
Molecular Formula	C10H24N2O2
Molecular Weight	204.31 g/mol
Synonyms	(2R,2'S)-2,2'-(Ethane-1,2-diyldiimino)dibutan-1-ol; (R,R')-2,2'-(Ethylenediimino)di-1-butanol; Ethambutol Impurity A; Ethambutol EP Impurity A; (R,R)-Ethambutol Related Substance A; EMB Impurity A; (+)-N,N'-Bis(1-hydroxymethylpropyl)ethylenediamine; (2R,2'R)-2,2'-(Ethylenediamino)dibutan-1-ol
EINECS	Contact for details

Quality Control

Our Ethambutol Related Compound A is manufactured and tested under strict quality management systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical characterization, including identity confirmation by spectroscopic methods and purity determination by chromatographic techniques. A detailed Certificate of Analysis (COA) is provided, documenting the results for identity, assay, and impurity profile to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This product is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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