Description

Terbutaline Impurity 11 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 Terbutaline, a widely used bronchodilator. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Terbutaline active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (HPLC, LC-MS) to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Terbutaline, meeting pharmacopeial standards (USP, EP).
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Terbutaline to understand degradation pathways and establish shelf-life.
• Research & Development: Supports chemical and pharmacological research related to Terbutaline, including metabolism studies and the synthesis of related compounds.

Basic Information

Product Name	Terbutaline Impurity 11
CAS No.	2387020-93-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terbutaline Related Compound 11; Terbutaline EP Impurity J; Terbutaline USP Impurity; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol Impurity; α-[[(1,1-Dimethylethyl)amino]methyl]-3,5-dihydroxybenzenemethanol Impurity; Terbutaline Degradation Product; Terbutaline Process Impurity
EINECS	Contact for details

Quality Control

Our Terbutaline Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the needs of cGMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

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%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0% w/w

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