Description

Salbutamol Impurity K is a designated impurity standard used in the analytical profiling and quality control of Salbutamol, a widely used bronchodilator. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Salbutamol drug substances and products. It serves as a key reference material for method development, validation, and routine impurity monitoring in compliance with stringent regulatory guidelines. Professionals in pharmaceutical R&D, quality assurance, and contract research organizations rely on this high-purity standard to maintain supply chain integrity and product quality.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for Salbutamol in accordance with ICH, USP, and EP guidelines.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or GC methods for impurity detection and quantification.
• Quality Control & Batch Release: Used in routine QC testing of Salbutamol Active Pharmaceutical Ingredients (APIs) and finished dosage forms to monitor impurity levels.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions during drug shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing procedures as required by United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other pharmacopoeias.

Basic Information

Product Name	Salbutamol Impurity K
CAS No.	898542-80-8
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	Albuterol Impurity K; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol; 5-[2-(tert-Butylamino)-1-hydroxyethyl]benzene-1,3-diol; Salbutamol Related Compound K; Albuterol Related Compound K; tert-Butylsaligenin; Salbutamol EP Impurity K
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity K is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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. The material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	98.0% - 102.0%

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