Description

Terbutaline Ep Impurity B Hemisulphate is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity for the quality control and analytical validation of Terbutaline, a widely used bronchodilator. It is an essential material for laboratories and manufacturers focused on ensuring drug safety, efficacy, and regulatory compliance. Professionals in pharmaceutical analysis, quality assurance, and regulatory affairs rely on this standard for method development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Terbutaline Ep Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels, ensuring Terbutaline API and formulations comply with pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Supports impurity isolation, characterization, and toxicological studies during the drug development lifecycle.

Basic Information

Product Name	Terbutaline Ep Impurity B Hemisulphate
CAS No.	153657-83-1
Molecular Formula	C₁₂H₁₉NO₃ • ½H₂SO₄
Molecular Weight	274.33 g/mol (free base)
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol hemisulfate; Terbutaline Impurity B (EP); Terbutaline Sulfate Impurity B; Terbutaline Related Compound B; (±)-Terbutaline hemisulfate impurity B; 5-[2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-1,3-benzenediol hemisulfate; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol hemisulfate
EINECS	Contact for details

Quality Control

Our Terbutaline Ep Impurity B Hemisulphate is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and related substances. We support compliance with ICH, EP, and USP guidelines, and specifications can be aligned with your specific pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed after each use to minimize exposure to atmospheric moisture.

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, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
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.