Description

Salbutamol Glyoxal Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a key marker in impurity profiling and method validation studies. It is primarily required by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and biotechnology industries for compliance with stringent regulatory standards.

Application

• Primary use as a certified reference standard for the identification and quantification of process-related impurities in Salbutamol API and finished drug products.
• Essential for analytical method development and validation (HPLC, LC-MS) to meet ICH Q2(R1) and other pharmacopeial guidelines.
• Critical component in stability studies and forced degradation studies to understand the degradation pathways of Salbutamol.
• Used in pharmaceutical quality control laboratories to establish specification limits and ensure batch-to-batch consistency.
• Valuable for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Serves as a research tool in academic and industrial settings for studying the metabolism and pharmacokinetics of Salbutamol.

Basic Information

Product Name	Salbutamol Glyoxal Impurity
CAS No.	72189-44-7
Molecular Formula	C13H19NO4
Molecular Weight	253.30 g/mol
Synonyms	1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol glyoxal adduct; Albuterol Glyoxal Impurity; Salbutamol Impurity G (Glyoxal); 4-[2-(tert-Butylamino)-1-hydroxyethyl]-1,2-benzenediol glyoxal impurity; RS-Glyoxal Adduct of Salbutamol; Ventolin Glyoxal Related Compound
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Glyoxal Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and high-purity requirements typical for pharmaceutical reference materials. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality assurance needs.

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); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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