Description

Procaterol Impurity 01 is a designated reference standard used in the analytical profiling and quality control of Procaterol, a selective β2-adrenergic receptor agonist. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Procaterol-based drug substances and products. It serves as a key marker for identifying and quantifying related substances during method development, stability studies, and regulatory batch release.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for qualitative and quantitative analysis in compliance with ICH Q3A/B guidelines.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods for Procaterol API.
• Quality Control and Batch Release: Used in-house by QC laboratories to monitor impurity levels in active pharmaceutical ingredients (APIs) and finished drug products.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Acts as a benchmark to track the formation of degradation products under various stress conditions (light, heat, humidity).
• Pharmacopoeial Testing: Potential use in testing to meet the specifications of pharmacopoeias such as USP, EP, or JP.

Basic Information

Product Name	Procaterol Impurity 01
CAS No.	62910-96-7
Molecular Formula	C16H22N2O3
Molecular Weight	290.36 g/mol
Synonyms	5-(1-Hydroxy-2-((1-methylethyl)amino)butyl)-8-hydroxycarbostyril; Procaterol Related Compound A; Procaterol EP Impurity A; Procaterol USP Related Compound; (±)-8-Hydroxy-5-[1-hydroxy-2-(isopropylamino)butyl]carbostyril; 8-Hydroxy-5-[1-hydroxy-2-[(1-methylethyl)amino]butyl]-2(1H)-quinolinone
EINECS	Contact for details

Quality Control

Every batch of Procaterol Impurity 01 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (IR, NMR), assay (HPLC), and related substance analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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