Description

Terbutaline Impurity 10 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of 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: Used as a certified reference material for the identification and quantification of specific impurities in Terbutaline drug substances and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and adherence to ICH guidelines.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Terbutaline formulations under various stress conditions.
• Research & Development: Used in R&D to study the degradation pathways, metabolism, and chemical behavior of Terbutaline.
• Quality Assurance/Quality Control (QA/QC): Provides a benchmark for in-house testing to ensure batch-to-batch consistency and purity of the active pharmaceutical ingredient (API).

Basic Information

Item	Detail
Product Name	Terbutaline Impurity 10
CAS No.	2352882-26-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terbutaline Related Compound; Terbutaline Impurity; Terbutaline Degradation Product; Terbutaline Process Impurity; (1,3-benzodioxol-5-yl)(tert-butylamino)ethanone derivative; 5-(2-(tert-Butylamino)-1-hydroxyethyl)benzene-1,3-diol impurity; 1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanone related substance
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material with care to prevent contamination.

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)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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