Description

Metaraminol Impurity 4 is a specified impurity and reference standard used in the analytical profiling of the pharmaceutical active ingredient, Metaraminol. This compound is critical for ensuring the purity, safety, and efficacy of Metaraminol-based drug formulations through rigorous quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Metaraminol drug substance and finished products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing and validating chromatographic methods to monitor impurities during stability studies and quality control.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and quality dossiers.
• Pharmacopoeial Testing: Employed in testing to comply with pharmacopoeial monographs (e.g., USP, EP, BP) that specify limits for known and unknown impurities.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions.
• Research & Development: Serves as a key reagent in R&D for studying the degradation pathways and impurity profile of Metaraminol.

Basic Information

Product Name	Metaraminol Impurity 4
CAS No.	20727-99-5
Molecular Formula	C9H13NO2
Molecular Weight	167.21 g/mol
Synonyms	1-(3-Hydroxyphenyl)-2-methylaminoethanol; 3-[1-Hydroxy-2-(methylamino)ethyl]phenol; Metaraminol Related Compound; Metaraminol EP Impurity; Metaraminol USP Impurity; α-(1-Aminoethyl)-3-hydroxybenzyl alcohol (methyl derivative); Nor-Metaraminol (common misnomer, verify structure)
EINECS	Contact for details

Quality Control

Every batch of Metaraminol Impurity 4 is manufactured and tested under strict quality management systems. The product undergoes comprehensive analytical characterization, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by validated chromatographic methods (HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidative degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0% w/w

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