Description

Adrenochrome Impurity 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 pharmaceutical products and related substances. It is primarily utilized by researchers and quality control laboratories in the pharmaceutical, biotechnology, and analytical chemistry sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Adrenochrome and related pharmaceutical intermediates.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and mass spectrometry (MS) methods.
• Quality Control (QC) & Quality Assurance (QA): Serves as a system suitability standard and for routine batch testing in pharmaceutical manufacturing to ensure product purity and compliance with ICH guidelines.
• Stability Studies: Employed in forced degradation and stability-indicating studies to monitor the formation of degradation products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Academic & Contract Research: Used in universities and contract research organizations (CROs) for biochemical research and analytical services.

Basic Information

Product Name	Adrenochrome Impurity 2
CAS No.	87708-46-1
Molecular Formula	C₉H₉NO₃
Molecular Weight	179.17 g/mol
Synonyms	3-Hydroxy-1-methyl-5,6-indolinedione; 1-Methyl-3-hydroxy-5,6-indolinedione; Adrenochrome related compound; Adrenochrome derivative; Adrenochrome analog; 5,6-Dihydroxy-1-methylindole-2,3-dione (tautomeric form); Adrenochrome Impurity B; Adrenolutin precursor
EINECS	Contact for details

Quality Control

Every batch of Adrenochrome Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support cGMP and ISO standards for research and pharmaceutical-grade materials.

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 at -20°C to maximize stability.

Specification

Item	Specification
Appearance	Reddish-brown to brown solid
Identification (IR)	Conforms to structure
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
Water Content (KF)	≤ 1.0% w/w

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