Description

Salbutamol Impurity 5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Salbutamol-based pharmaceutical products by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality control departments, and research institutions in the pharmaceutical industry focused on method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Salbutamol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles, ensuring batch-to-batch consistency and compliance with pharmacopoeial specifications (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products in Salbutamol formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate control over product impurities.
• Research & Development: Supports impurity profiling, metabolic studies, and the synthesis of related compounds in pharmaceutical R&D.

Basic Information

Product Name	Salbutamol Impurity 5
CAS No.	1221726-71-1
Molecular Formula	C13H21NO3
Molecular Weight	239.31 g/mol
Synonyms	Albuterol Impurity 5; 5-(2-((1,1-Dimethylethyl)amino)-1-hydroxyethyl)-2-hydroxybenzaldehyde; 2-Hydroxy-5-[(2-((tert-butylamino)-1-hydroxyethyl)]benzaldehyde; Salbutamol Related Compound 5; Salbutamol EP Impurity E; Albuterol Related Compound 5
EINECS	Contact for details

Quality Control

Every batch of Salbutamol Impurity 5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity analysis, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with each shipment to support your quality and regulatory requirements.

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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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