Description

Terbutaline Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Terbutaline-based pharmaceutical products by enabling accurate identification and quantification of impurities. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams involved in method development and validation.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component in pharmaceutical quality control (QC) for impurity profiling and batch release testing.
• Essential for regulatory compliance and submissions (e.g., FDA, EMA) requiring impurity identification.
• Used in stability studies to monitor degradation pathways of Terbutaline drug substances and products.
• Valuable for pharmacological and toxicological research to understand impurity impact.
• Serves as a key impurity marker in high-performance liquid chromatography (HPLC) and related chromatographic analyses.

Basic Information

Product Name	Terbutaline Impurity
CAS No.	52144-90-8
Molecular Formula	C₁₂H₁₉NO₃
Molecular Weight	225.28 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol; Terbutaline Related Compound; Terbutaline EP Impurity; Terbutaline USP Impurity; Terbutaline Degradation Product; BRL-10833 Impurity
EINECS	Contact for details

Quality Control

Our Terbutaline Impurity is manufactured under strict quality systems to ensure the highest standards of purity and consistency. Each batch is subjected to comprehensive analytical testing, including HPLC, NMR, and MS, to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting all test results against stringent in-house specifications. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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