Description

Terbutaline Impurity CAS NO 882066-15-1 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-based pharmaceutical products. It is primarily required by analytical laboratories, quality control (QC) departments, and research institutions involved in pharmaceutical development and manufacturing. The impurity serves as a vital marker for method validation, stability studies, and impurity profiling in accordance with ICH guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for identifying and quantifying related substances in Terbutaline API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) for drug substance and product stability testing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization data.
• Research & Development (R&D): Utilized in synthetic chemistry research to study degradation pathways and the synthesis of Terbutaline.

Basic Information

Product Name	Terbutaline Impurity
CAS No.	882066-15-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terbutaline Related Compound; Terbutaline Impurity Standard; Terbutaline Reference Standard; Terbutaline System Suitability Impurity; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol Impurity; (RS)-1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol Impurity; 5-[2-[(tert-Butylamino)-1-hydroxyethyl]benzene-1,3-diol Impurity
EINECS	Contact for details

Quality Control

Our Terbutaline Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing purity, assay, and impurity profile. Our quality protocols are designed to support compliance with ICH Q3A, Q3B, and relevant pharmacopeial standards (e.g., USP, EP).

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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