Description

Terbutaline Impurity 7 is a high-purity reference standard specifically used in the analytical profiling and quality control of Terbutaline, a widely used bronchodilator. This compound is critical for pharmaceutical manufacturers and research laboratories to identify, quantify, and monitor this specific impurity, ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is an essential material for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Terbutaline Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation during Terbutaline synthesis.

Basic Information

Product Name	Terbutaline Impurity 7
CAS No.	113051-10-8
Molecular Formula	C₁₂H₁₉NO₃
Molecular Weight	225.28 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol Impurity 7; Terbutaline Related Compound 7; 5-[2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-1,3-benzenediol Impurity; Terbutaline EP Impurity G; Terbutaline USP Related Compound; α-[[(1,1-Dimethylethyl)amino]methyl]-3,5-dihydroxybenzenemethanol Impurity; Bricanyl Impurity 7
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity 7 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that include detailed results from advanced analytical techniques such as HPLC, GC, NMR, and MS to confirm identity, purity, and strength. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference materials, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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