Description

Salbutamol Impurity 87 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Salbutamol (Albuterol) drug substances and finished pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Salbutamol API and its formulations.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure drug substance and product purity meets pharmacopeial (USP, EP, BP) specifications.
• Stability Studies: Used to track and quantify the formation of this specific impurity during forced degradation and long-term stability studies of Salbutamol products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemical behavior of Salbutamol.

Basic Information

Product Name	Salbutamol Impurity 87
CAS No.	115787-53-6
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	Albuterol Impurity 87; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol; 2-(tert-Butylamino)-1-(3,5-dihydroxyphenyl)ethanol; Salbutamol Related Compound H (EP); Albuterol Related Compound H; Salbutamol EP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity 87 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical parameters. Our quality commitment aligns with the requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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 single 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.