Description

Procaterol Impurity 7 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Procaterol, a selective β2-adrenergic receptor agonist. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development and regulatory compliance. Ensuring the integrity of this impurity standard is essential for accurate impurity profiling and meeting stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of related substances in Procaterol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical system suitability component in HPLC, UPLC, and LC-MS methods to ensure specificity, accuracy, and robustness.
• Stability Studies: Employed to monitor the formation of degradation products in Procaterol formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to comply with ICH Q3A/B guidelines.
• Quality Control (QC) Testing: Acts as a primary standard in routine QC laboratories for batch release testing of Procaterol APIs to ensure purity and safety.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity during manufacturing.

Basic Information

Product Name	Procaterol Impurity 7
CAS No.	1640918-78-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Procaterol Related Compound 7; Procaterol EP Impurity C; Procaterol USP Impurity; Procaterol Degradant; 5-(1-Hydroxy-2-((1-methylethyl)amino)butyl)-1,3-benzenediol impurity; Procaterol Isomer; Procaterol Process Impurity
EINECS	Contact for details

Quality Control

Our Procaterol Impurity 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be sealed under an inert atmosphere if specified.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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