Description

Salbutamol Impurity 42 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Salbutamol, a widely used bronchodilator. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Salbutamol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to meet ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Salbutamol to ensure it meets pharmacopeial standards (USP, EP, BP).
• Stability Studies: Employed to monitor the formation of degradation products in Salbutamol formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies and to understand the degradation pathways of Salbutamol.

Basic Information

Item	Details
Product Name	Salbutamol Impurity 42
CAS No.	18910-69-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albuterol Impurity 42; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol; 3,5-Dihydroxy-α-[(tert-butylamino)methyl]benzyl alcohol; Salbutamol related compound 42; Salbutamol EP Impurity B
EINECS	Contact for details

Quality Control

Our Salbutamol Impurity 42 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every 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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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