Description

Salbutamol Related Compound 1 is a designated impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Salbutamol. Its precise identification and quantification are critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations. This compound is essential for quality control laboratories in the pharmaceutical industry, particularly those involved in the development, manufacturing, and regulatory compliance of respiratory medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development, validation, and routine quality control testing of Salbutamol API and its formulations.
• HPLC/LC-MS Calibration: Used to calibrate chromatographic systems for the accurate detection and quantification of specific impurities in compliance with ICH Q3A and Q3B guidelines.
• Stability Studies: Employed to monitor the formation of degradation products in Salbutamol drug products under various stress conditions (e.g., heat, light, humidity).
• Pharmacopoeial Testing: Supports testing procedures mandated by pharmacopoeias such as USP, EP, and BP for related substances analysis.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate control over the impurity profile of the drug substance.
• Research and Development: Used in R&D settings to study the degradation pathways and impurity formation mechanisms of Salbutamol.

Basic Information

Product Name	Salbutamol Related Compound 1
CAS No.	156339-89-8
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	4-[2-(tert-Butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol; Salbutamol Impurity 1; Albuterol Related Compound 1; 1-(3,5-Dihydroxyphenyl)-2-(tert-butylamino)ethanol; Ventolin Related Compound 1; 156339-89-8; Salbutamol EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Related Compound 1 is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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