Description

Terbutaline Impurity B is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Terbutaline. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Terbutaline Impurity B in Terbutaline API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation in Terbutaline formulations.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Terbutaline.
• Quality Assurance/Quality Control (QA/QC): Used for system suitability testing, as a control in batch release testing, and to ensure compliance with pharmacopeial monographs (USP, EP).

Basic Information

Product Name	Terbutaline Impurity B
CAS No.	94120-05-5
Molecular Formula	C₁₂H₁₉NO₃
Molecular Weight	225.28 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol; 3,5-Dihydroxy-α-[(1,1-dimethylethyl)amino]methyl]benzenemethanol; Terbutaline Related Compound B; Terbutaline EP Impurity B; Terbutaline USP Impurity B
EINECS	Contact for details

Quality Control

Our Terbutaline Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any 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.