Description

Salbutamol Related Compound 2 is a designated impurity and reference standard used in the pharmaceutical quality control process. This compound is critical for ensuring the purity, safety, and efficacy of Salbutamol (Albuterol) drug substances and finished products through precise analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing. Its use is essential for compliance with stringent pharmacopeial monographs from the USP, EP, and other international regulatory agencies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and control specified impurities in Salbutamol API and its formulations (e.g., inhalers, tablets).
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to meet ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Release Testing: Employed in routine QC laboratories for the assay and related substances testing of Salbutamol to ensure batch-to-batch consistency and compliance with regulatory filings.
• Pharmacopeial Testing: Essential for conducting tests as per United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and British Pharmacopoeia (BP) monographs for Salbutamol.
• Stability Studies: Used to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of ICH stability-indicating methods.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory compliance documentation.

Basic Information

Product Name	Salbutamol Related Compound 2
CAS No.	51234-21-0
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	Albuterol Related Compound 2; 1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; α-[(tert-Butylamino)methyl]-3,5-dihydroxybenzyl alcohol; 5-[1-Hydroxy-2-[(1,1-dimethylethyl)amino]ethyl]-1,3-benzenediol; Salbutamol Impurity B; Albuterol Impurity B
EINECS	Contact for details

Quality Control

Our Salbutamol Related Compound 2 is manufactured and controlled under a strict quality management system. Each batch undergoes rigorous analytical testing, including identification (IR, NMR), purity assay (HPLC), and control of specified and unspecified impurities, to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial standards (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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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