Description

Salbutamol Impurity 6 CAS NO 870076-73-6 is a high-purity reference standard used for the identification, qualification, and quantification of related substances in Salbutamol (Albuterol) drug substances and products. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by analytical laboratories, quality control departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development, validation, and routine quality control testing of Salbutamol API and finished dosage forms.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and LC-MS analyses to identify and quantify this specific impurity, supporting regulatory filings (e.g., ANDA, NDA) and stability studies.
• Pharmacopoeial Compliance: Essential for testing to meet the stringent impurity limits specified in pharmacopoeial monographs (USP, EP, BP, JP) for Salbutamol.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this impurity under various stress conditions (light, heat, humidity, acid/base).
• Manufacturing Process Control: Helps API manufacturers monitor and control the formation of this impurity during synthesis and purification processes.
• Research and Development: Used in academic and industrial R&D for studying the degradation pathways and metabolism of Salbutamol.

Basic Information

Product Name	Salbutamol Impurity 6
CAS No.	870076-73-6
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	Albuterol Impurity 6; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol; 2-(tert-Butylamino)-1-(3,5-dihydroxyphenyl)ethanol; Salbutamol Related Compound 6; 870076-73-6; tert-Butyl[2-(3,5-dihydroxyphenyl)-2-hydroxyethyl]amine
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
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 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.