Description

Adrenaline Impurity 16 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of adrenaline (epinephrine) and related pharmaceutical products by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in adrenaline (epinephrine) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC analytical methods in quality control laboratories.
• Stability Studies: Employed in forced degradation and long-term stability studies of adrenaline formulations to monitor impurity formation pathways and rates.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control & Batch Release: Acts as a system suitability standard and a quantitative calibrant in the routine QC testing of adrenaline API batches to ensure compliance with pharmacopeial monographs (USP, EP, JP).
• Research & Development: Used in R&D settings to study the synthesis pathways, degradation mechanisms, and metabolic byproducts of adrenaline and its analogs.

Basic Information

Product Name	Adrenaline Impurity 16
CAS No.	1894824-44-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Epinephrine Impurity 16; Adrenaline Related Compound 16; 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, (4R)-isomer (IUPAC tentative); (R)-4-[(R)-1-Hydroxy-2-(methylamino)ethyl]benzene-1,2-diol; Adrenaline process impurity; ARCI-16; Epi Imp 16
EINECS	Contact for details

Quality Control

Every batch of Adrenaline Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards for reference materials. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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