Description

Terbutaline Impurity 4 is a specified impurity of the bronchodilator drug Terbutaline, used in pharmaceutical development and quality control. This compound is critical for ensuring the purity, safety, and efficacy of Terbutaline sulfate active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Terbutaline and related substances.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed as a system suitability standard and for assessing impurity levels in Terbutaline API batches to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH).
• Stability Studies: Aids in identifying and quantifying degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of Terbutaline.

Basic Information

Product Name	Terbutaline Impurity 4
CAS No.	52144-92-0
Molecular Formula	C₁₂H₁₉NO₃
Molecular Weight	225.28 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; 5-[2-(tert-Butylamino)-1-hydroxyethyl]benzene-1,3-diol; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol; Terbutaline Related Compound; Terbutaline EP Impurity; Terbutaline Sulfate Impurity
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
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%
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.