Description

Terbutaline Impurity CAS NO 1226543-90-3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Terbutaline sulfate, a widely used bronchodilator. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Used 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 & Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Terbutaline.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of ICH stability protocols.
• Regulatory Submissions: Provides essential data for impurity characterization reports required for Drug Master Files (DMFs), ANDAs, and INDs submitted to agencies like the FDA and EMA.
• Pharmacopeial Testing: Supports testing to comply with monograph requirements in the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).

Basic Information

Product Name	Terbutaline Impurity
CAS No.	1226543-90-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terbutaline Related Compound; Terbutaline Sulfate Impurity; Terbutaline Degradant; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol Impurity; Bricanyl Impurity; Brethine Impurity; Arubendol Impurity
EINECS	Contact for details

Quality Control

Every batch of Terbutaline Impurity (CAS 1226543-90-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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