Description

Terbutaline Impurity 4 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, a widely used bronchodilator. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Terbutaline API and its finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and other chromatographic methods for quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions to establish product shelf-life.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Terbutaline, supporting the development of more stable formulations.
• Quality Control Testing: Acts as a system suitability standard and a comparator in routine batch release testing of Terbutaline to ensure it meets pharmacopeial specifications.

Basic Information

Product Name	Terbutaline Impurity 4
CAS No.	476176-83-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol impurity; Terbutaline Related Compound; Terbutaline EP Impurity; Terbutaline USP Impurity; Terbutaline degradation product; Bronchodilator impurity; (RS)-1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol impurity
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity levels is provided with each shipment to support your quality and regulatory 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. Handle under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.1%

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