Description

Salbutamol Ep Impurity B Hcl is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound serves as a specified impurity for the active pharmaceutical ingredient Salbutamol, enabling precise monitoring and control to ensure final drug product safety and efficacy. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and production, particularly for those adhering to stringent pharmacopeial guidelines such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Salbutamol sulfate impurities.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in API and finished dosage form manufacturing to ensure compliance with EP, USP, and ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor impurity levels in drug substances and products under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in studies to understand the degradation pathways and stability profile of Salbutamol.

Basic Information

Item	Details
Product Name	Salbutamol Ep Impurity B Hcl
CAS No.	112337-52-7
Molecular Formula	C13H22ClNO3
Molecular Weight	275.77 g/mol
Synonyms	Salbutamol Impurity B Hydrochloride; 1-(3,5-Dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]ethanol hydrochloride; Albuterol Impurity B HCl; 2-(tert-Butylamino)-1-(3,5-dihydroxyphenyl)ethanol hydrochloride; Salbutamol Related Compound B; EP Impurity B of Salbutamol; Ventolin Impurity B HCl
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Ep Impurity B Hcl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and mass spectrometry.

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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Impurities (HPLC)	Individually ≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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