Description

Terbutaline Impurity C is a specified impurity and degradation product of the bronchodilator drug Terbutaline. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Terbutaline-based pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Terbutaline sulfate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability-Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Terbutaline and to establish shelf-life specifications.
• Quality Control & Assurance (QC/QA): Acts as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B, USP, EP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet regulatory requirements.
• Research and Development: Utilized in synthetic chemistry research to study the formation and mitigation of process-related impurities during API manufacturing.

Basic Information

Product Name	Terbutaline Impurity C
CAS No.	139508-58-0
Molecular Formula	C12H19NO3
Molecular Weight	225.29 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol; Terbutaline Related Compound C; Terbutaline EP Impurity C; Terbutaline USP Impurity C; Terbutaline Degradation Product; Bricanyl Impurity C
EINECS	Contact for details

Quality Control

Our Terbutaline Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with relevant standards for pharmaceutical reference materials. Our quality commitment ensures reliable and consistent performance for your critical analytical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure optimal stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.