Description

Procatero Impurity CAS NO 90098-93-4 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential tool for analytical chemists and quality control professionals in the pharmaceutical and biotechnology industries who require reliable standards for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Procaterol hydrochloride and related drug substances.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC analytical methods in compliance with ICH Q2(R1) and Q3B guidelines.
• Quality Control & Assurance: Employed in routine QC testing of bulk drug substances and finished pharmaceutical products to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control strategies.
• Stability Studies: Used as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of the parent drug.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis in academic and industrial R&D laboratories.

Basic Information

Product Name	Procatero Impurity
CAS No.	90098-93-4
Molecular Formula	C16H22N2O3
Molecular Weight	290.36 g/mol
Synonyms	Procaterol Impurity; Procaterol Related Compound; 8-Hydroxy-5-[(1R)-1-hydroxy-2-[(1-methylethyl)amino]butyl]-2(1H)-quinolinone; (R)-8-Hydroxy-5-[1-hydroxy-2-(isopropylamino)butyl]quinolin-2(1H)-one; Procaterol Quinolinone Metabolite; Procaterol Degradant
EINECS	Contact for details

Quality Control

Every batch of Procatero Impurity CAS NO 90098-93-4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Heavy Metals	≤ 20 ppm

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