Description

Terbutaline Impurity 8 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, a widely used bronchodilator, by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of Terbutaline-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Terbutaline active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or GC methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure drug substance and product specifications are met.
• Stability Studies: Employed to track the formation of degradation products in Terbutaline formulations under various stress conditions (ICH Q1A).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacological Research: Serves as a tool in metabolic and pharmacokinetic studies to understand the degradation pathways of Terbutaline.

Basic Information

Product Name	Terbutaline Impurity 8
CAS No.	28924-20-1
Molecular Formula	C₁₂H₁₉NO₃
Molecular Weight	225.28 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; 5-[2-(tert-Butylamino)-1-hydroxyethyl]benzene-1,3-diol; Terbutaline Related Compound; Terbutaline EP Impurity; Terbutaline USP Impurity; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards (USP, EP, BP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.