Description

Procaterol Impurity 4 CAS NO 63235-39-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Procaterol, a selective β2-adrenergic receptor agonist. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Procaterol Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control & Assurance: Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Procaterol to understand degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Chemical Research: Used in academic and industrial research to study the synthesis, metabolism, and pharmacokinetics of Procaterol and related compounds.

Basic Information

Item	Details
Product Name	Procaterol Impurity 4
CAS No.	63235-39-2
Molecular Formula	C16H22N2O3
Molecular Weight	290.36 g/mol
Synonyms	5-(1-Hydroxy-2-((1-methylethyl)amino)butyl)-8-hydroxycarbostyril; Procaterol Related Compound; Procaterol EP Impurity; Procaterol USP Impurity; Procaterol Degradant; (±)-5-[1-Hydroxy-2-(isopropylamino)butyl]-8-quinolinol; 8-Hydroxy-5-[1-hydroxy-2-(propan-2-ylamino)butyl]quinolin-2(1H)-one
EINECS	Contact for details

Quality Control

Every batch of Procaterol Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions 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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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