Description

Terbutaline Impurity 27 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Terbutaline sulfate, a widely used bronchodilator, by serving as a known impurity for method development and validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of respiratory medications.

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: Critical for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Stability Studies: Employed to identify and track degradation products that may form during the forced degradation or long-term stability testing of Terbutaline formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Terbutaline to minimize impurity formation.

Basic Information

Product Name	Terbutaline Impurity 27
CAS No.	147942-88-9
Molecular Formula	C₁₂H₁₉NO₃
Molecular Weight	225.28 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol Impurity 27; Terbutaline Related Compound 27; Terbutaline Sulfate Impurity 27; 5-[2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl]-1,3-benzenediol; (RS)-1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol impurity; Bricanyl Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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); ensure the container is sealed tightly after each use to prevent degradation due to moisture absorption.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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