Description

Terbutaline Related Compound (2-(Benzylmethylamino)-3',5'-Dihydroxyacetophenone Hcl) is a high-purity chemical reference standard, critical for ensuring the quality and safety of pharmaceutical products. This compound, with CAS number 857432-92-9, serves as a key impurity marker and analytical standard in the development and quality control of Terbutaline sulfate, a widely used bronchodilator. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific related compound in Terbutaline sulfate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in compliance with ICH Q2(R1) guidelines.
• Pharmacopeial Testing and Compliance: Essential for testing to meet the specifications of the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeias for Terbutaline sulfate.
• Stability Studies and Forced Degradation Studies: Employed to understand the degradation pathways of Terbutaline and to establish appropriate shelf-life and storage conditions for drug substances and products.
• Quality Control and Batch Release Testing: A vital component in the routine QA/QC testing of Terbutaline sulfate batches to ensure impurity levels are within specified limits for patient safety.
• Regulatory Submissions: Provides necessary data and reference standards for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.

Basic Information

Product Name	Terbutaline Related Compound (2-(Benzylmethylamino)-3',5'-Dihydroxyacetophenone Hcl)
CAS No.	857432-92-9
Molecular Formula	C17H20ClNO3
Molecular Weight	321.80 g/mol
Synonyms	2-(Benzylmethylamino)-3',5'-dihydroxyacetophenone hydrochloride; 1-(3,5-Dihydroxyphenyl)-2-[(N-methylbenzyl)amino]ethanone hydrochloride; Terbutaline Impurity; Terbutaline Related Substance; Terbutaline Sulfate Related Compound A (potential designation); α-[(Methylbenzylamino)methyl]-3,5-dihydroxybenzyl alcohol hydrochloride (related form); Benzylmethylamino Dihydroxyacetophenone HCl
EINECS	Contact for details

Quality Control

Our Terbutaline Related Compound is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by IR and MS, residual solvent analysis, and precise quantification of related substances. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines. Specifications are aligned with the requirements for pharmaceutical reference standards.

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), in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

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)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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