Description

Salbutamol Impurity H is a high-purity chemical reference standard specifically identified and characterized for pharmaceutical analysis. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Salbutamol (Albuterol) drug substances and products through rigorous impurity profiling. It is an essential tool for quality control laboratories and R&D departments within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material for the identification and quantification of Salbutamol Impurity H in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Crucial for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity levels against strict pharmacopeial limits (e.g., USP, EP, BP) to ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of drug stability programs.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research on Degradation Pathways: Aids in research to understand the degradation mechanisms of Salbutamol, helping to improve formulation and packaging strategies.

Basic Information

Item	Detail
Product Name	Salbutamol Impurity H
CAS No.	2252153-95-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Albuterol Impurity H; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol impurity H; (RS)-1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol Impurity H; Salbutamol Related Compound H; Potential process-related impurity of Salbutamol
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity H is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature (typically 15-25°C) or as specified on the label or COA. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets internal specifications
Water Content (KF)	≤ 5.0%

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