Description

Salbutamol Impurity 22 is a designated impurity standard used in the analytical profiling and quality control of Salbutamol (Albuterol) active pharmaceutical ingredients (APIs) and finished drug products. This compound is critical for ensuring the purity, safety, and regulatory compliance of respiratory medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Salbutamol Impurity 22 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting impurity limits in the routine QC testing of Salbutamol API and formulations.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the US FDA and EMA.
• Pharmacopoeial Testing: Supports testing to meet the monograph specifications of USP, EP, BP, and other international pharmacopoeias.

Basic Information

Product Name	Salbutamol Impurity 22
CAS No.	232590-81-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albuterol Impurity 22; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol (related to Salbutamol); Salbutamol Related Compound 22; Salbutamol EP Impurity G; Potential process-related impurity of Salbutamol
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity 22 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Handle the material in accordance with good laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.